Overview of Patient Safety Learning Laboratory (PSLL) Projects

Introduction

Patient safety learning laboratories (PSLLs) take a systems engineering approach to allow researchers and healthcare providers to evaluate clinical processes and enhance work and information flow to improve patient safety. The learning laboratories use cross-disciplinary teams to address patient safety-related challenges. This approach can involve evaluating the physical (built) environment, technological factors such as health information technology (IT), and clinical workflow processes relevant to the patient's condition. Emphasis is placed on the system-level confluence of these multiple factors in enhancing patient safety.

AHRQ has been supporting the PSLLs through the Agency's patient safety program. In 2014 and 2015, AHRQ funded 13 multiyear demonstration grants through the P30 mechanism to evaluate the use and effectiveness of various systems engineering approaches and the role they can play in improving the safety and quality of healthcare delivery.

In 2018 and 2019, AHRQ funded 17 additional PSLL grants (9 in 2018, and 8 in 2019) through the R18 mechanism and expanded the focus to include projects that aim to improve diagnosis and treatment issues. In 2022 and 2023, AHRQ funded 17 additional PSLL grants under the R18 mechanism (5 in 2022 and 12 in 2023).

Following are summaries of these projects. Each summary includes the project title, principal investigator (and co-PIs where applicable) and organization, AHRQ grant number, project start and end dates, and a description of the focus and goals of the project. Contact information for each principal investigator is at the end, after all the summaries.

AHRQ's PSLLs have the potential to improve the safety of healthcare as they inform providers, health educators, payers, policymakers, patients, and the public about the practical and effective use of systems engineering approaches in improving patient safety.

Project Descriptions

P30 Projects Funded in 2014 and 2015

Brain Health Patient Safety Learning Laboratory (Brain Safety Lab)

Principal Investigator: Christopher Callahan, M.D., Indiana University, Indianapolis, IN
AHRQ Grant No.: HS24384
Project Period: 09/30/15-03/31/20
Description: This learning laboratory focused on preventing harms to brain health among vulnerable older adults. The Brain Safety Lab was a collaboration between the Indiana University’s Schools of Medicine, Informatics and Computing, and Nursing; Purdue University’s Schools of Biomedical and Industrial Engineering and its College of Pharmacy; the Regenstrief Institute; and Eskenazi Health, a safety-net healthcare system.

The project aims were to:

1. Reduce the use of unsafe medications with anticholinergic (ACh) side effects.
2. Prevent repeated episodes of hypoglycemia (HG) among older adults with diabetes.

Using a five-phase process (i.e., problem analysis, design, development, implementation, and evaluation), the lab team developed the Brain Buddy, a consumer-facing mHealth application to inform and encourage older adults to initiate dialogue with a clinician regarding the risks and benefits of their anticholinergic medications. The lab tested the usability and feasibility of the tool on primary care patients, finding that 100 percent of participants indicated they were more informed, with 94 percent stating they would speak to their physician about their anticholinergic-related risk. On followup, 82 percent reported having spoken to their physician about their anticholinergic medication, a rate independently confirmed by physicians.

In addition, the Brain Safety Lab team developed a conceptual model for over-the-counter medication purchase and use by older adults based on habits and deliberation. This model suggests several design directions for future consumer-oriented interventions to promote medication safety.

To date, this PSLL's work has resulted in at least 18 peer-reviewed journal publications, with nearly 130 citations in other publications.

A sample of the lab's publications is listed below. A longer description of its work and associated publications is available.

Publications

• Holden RJ, Abebe E. Medication transitions: vulnerable periods of change in need of human factors and ergonomics. Appl Ergon 2021;90:103279.
• Holden RJ, et al.; Brain Health Patient Safety Laboratory. Usability and feasibility of consumer-facing technology to reduce unsafe medication use by older adults. Res Social Adm Pharm 2020;16(1):54-61.
• Khan SH, et al. Decreasing delirium through music: a randomized pilot trial. Am J Crit Care 2020;29(2):e31-e38.

Building an Ambulatory Patient Safety Learning Laboratory for Diverse Populations (ASCENT)

Principal Investigator: Urmimala Sarkar, M.D., University of California-San Francisco, San Francisco, CA
AHRQ Grant No.: HS023558
Project Period: 09/30/14-09/29/2020
Description: The overall goal of this project was to examine the epidemiology of patient safety in ambulatory care settings that care for diverse, low-income populations in the San Francisco Heath Network (SFHN).

The project aims were to:

1. Create a transdisciplinary patient safety learning laboratory composed of stakeholders and experts in patient safety, reliability science, design thinking, and operational leadership to collaborate on creative and effective solutions.
2. Design and iterate technical and workflow solutions for high-priority ambulatory safety issues in a publicly funded, safety-net healthcare system caring for diverse, vulnerable patients. Specifically, ASCENT addressed (a) test results management, (b) outpatient monitoring for high-risk conditions, and (c) enhanced medication comprehension to reduce adverse drug events.
3. Implement and evaluate solutions using implementation sciences methodology.
4. Scale up effective solutions across the health system and disseminate them among safety-net health systems.

The ASCENT Lab developed, piloted, and implemented a needs-driven technical and culture-based solution for subcritical test results, management of high-risk conditions and their treatments, and patient-centered medication language with rich involvement from frontline clinicians and leadership in the health system.

An example of innovations created by the ASCENT Lab include:

• An electronic registry for urology clinic staff to monitor men on active surveillance for prostate cancer risk. The goal is to assess the efficacy and feasibility of health information technology at a safety-net hospital to ensure patients receive guideline-recommended care.
• A health information technology platform that monitors patients with head and neck cancer to improve timely and successful completion of guideline-based care processes.
• An electronic dashboard (integrated into a preexisting electronic health record) and standardized workflow to track patients' laboratory results, identify patients requiring followup, and facilitate the use of a validated nomogram for dose adjustment.

To date, this PSLL’s work has resulted in at least 34 peer-reviewed journal publications, with nearly 200 citations in other publications.

A sample of the lab’s publications is listed below.  A longer description of its work and associated publications is available.

Publications

• Cedars B, et al. An electronic registry to improve adherence to active surveillance monitoring among men with prostate cancer at a safety-net hospital: protocol for a pilot study. Pilot Feasibility Stud 2019 Aug 14;5:101.
• Fontil V, et al. Evaluation of a health information technology-enabled panel management platform to improve anticoagulation control in a low-income patient population: protocol for a quasi-experimental design. JMIR Res Protoc 2020;9(1):e13835.
• Nouri SS, et al. Assessing mobile phone digital literacy and engagement in user-centered design in a diverse, safety-net population: mixed methods study. JMIR Mhealth Uhealth 2019;7(8):e14250.

Caregiver Innovations to Reduce Harm in Neonatal Intensive Care

Principal Investigator: Eric J. Thomas, M.D., University of Texas, Houston, TX
AHRQ Grant No.: HS24459
Project Period: 09/30/15–09/29/21
Description: The goal of the University of Texas Patient Safety Learning Laboratory was to create an environment of collaborative learning focused on reducing all-cause preventable harm by 50 percent in the neonatal intensive care unit (NICU).

The specific aims were to:

1. Increase parent and family engagement.
2. Improve staff training on nutrition and respiratory care in neonates.
3. Decrease central line-associated bloodstream infections.

This lab used three cores of multidisciplinary experts to engage NICU caregivers and develop a multimethod trigger-based, prospective clinical surveillance system to detect all-cause preventable harm. More specifically, the following list provides examples of individual core accomplishments:

• The measurement core developed causal-loop diagrams and a simulation model to help identify various individual-, team-, and unit/organizational-level factors associated with harms and quality improvement (QI)-related outcomes. This model showed how policies designed to affect those factors resulted in changes to outcomes. The measurement core also created a tool to assess the processes and teamwork during QI team meetings and a new survey to measure stakeholder attitudes about QI interventions.
• The electronic health record (EHR) core identified and developed the Safer Dx Trigger Tools Framework that enables health systems to develop and implement e-trigger tools. It also identified nine challenges to help healthcare organizations, health information technology developers, researchers, policymakers, and funders focus their efforts on health information technology-related patient safety. As of August 2021, the Centers for Medicare & Medicaid Services requires eligible hospitals to attest to having completed an annual self-assessment of their EHR using SAFER Guides.
• The parent engagement core used an observational, mixed-methods design of field observations, interviews, and surveys with parent advisors, clinicians, and leaders involved with the NICU. This core obtained data to detect preventable harms in the NICU and the impact of parent engagement on QI initiatives. They found that parents of hospitalized infants in the NICU observe and can report problems/harms, if asked. Through this work, researchers describe a stepwise approach to implementing a QI-based parent advisory council that could be applicable to any hospital or ambulatory unit.

A sample of this lab's publications is below. A longer description of this lab’s work and associated publications is available.

Publications

• Nether K. Implementing a robust process improvement program in the neonatal intensive care unit to reduce harm. J Healthc Qual 2022 Jan-Feb 01;44(1):23-30.
• Sedlock EW, et al. Creating a comprehensive, unit-based approach to detecting and preventing harm in the neonatal intensive care unit. J Patient Saf Risk Manag 2018;23(4):167-75.
• Sittig DF, et al. Adherence to recommended electronic health record safety practices across eight health care organizations. J Am Med Inform Assoc 2018;25(7):913-8.

Engineering Highly Reliable Learning Lab

Principal Investigator: Sara Singer, Ph.D., Harvard University, Cambridge, MA
AHRQ Grant No.: HS24453
Project Period: 09/30/15–09/29/21
Description: The goal of this learning lab was to enhance capacity for innovation and develop highly reliable systems that address communication and coordination challenges that pose patient safety risks at the intersection of primary and specialty care. A five-stage systems engineering cycle, including problem analysis, design, development, implementation, and evaluation, drove the lab’s efforts to develop highly reliable systems within four Harvard-affiliated primary care practices and their specialty care partners.

The specific aims were to:

1. Build a shared infrastructure that comprised an administrative/learning core, an engineering core, and multidisciplinary teams to stimulate a systematic approach for patient safety innovation.
2. Engage in three research projects that applied systems engineering to the development of innovative solutions for improving health information technology-supported processes and designing highly reliable systems that are generalizable.
3. Implement and spread redesigned systems across a range of hospital/community-based primary care practices and test systems’ generalizability in alternative settings and conditions.
4. Assess the impact of redesigned systems on practice, team, provider, and patient outcomes and disseminate findings, tools, and resources for national replication.

Over 5 years, four synergistic projects engaged health system-based reengineering and design teams in problem analysis and hands-on development, testing, and implementation of communication and coordination systems in different settings.

EHRLL used a variety of systems engineering and problem analysis tools at four institutions to facilitate a successful learning system and find solutions to problems relevant to each institution. Tools included process mapping, swim lane diagrams, functional resonance analysis method, failure modes and effects analysis, contrast analysis, run charts, and predictive modeling dashboards.

EHRLL researchers developed a model of the constraint management process to show that each institution’s teams over time experienced hierarchical and heterarchical constraints. They used direct and indirect tactics to overcome these constraints. Ultimately, these tactics helped each institution achieve milestones and maintain momentum.

One of the lab’s successes was at Boston Children's Hospital, which created a new approach to patient engagement. They redefined the facility's care pathway and spread this care pathway across the United States via the American Academy of Cerebral Palsy and Developmental Medicine. The hospital is now using the same systems engineering methods to cope with COVID-19.

One of the projects at Brigham and Women's Hospital developed a system of workflows to improve management of chronic opioid prescribing.

In response to COVID-19, EHRLL's engineering core team developed the Northeastern University Hospital Surge Capacity Planning Model to help health systems project hospital-specific demand for key resources.

A sample of EHRLL's publications is listed below. A longer description of this lab’s work and associated publications is available.

Publications

• Bargal B, et al. Use of systems-theoretic process analysis to design safer opioid prescribing processes. IISE Trans Occup Ergon Hum Factors 2018;6(3-4):200-8.
• Das P, et al. Engineering safer care coordination from hospital to home: lessons from the USA. Future Healthc J 2018;5(3):164-70.
• Atkinson MK, et al. Evaluating a patient safety learning lab intervention to create an interdisciplinary ecosystem for healthcare innovation. Health Care Manage Rev 2022 Jan 27.

Enhancing Patient Safety Through Cognition and Communication (M-Safety Lab)

Principal Investigator: Sanjay Saint, M.D., M.P.H., University of Michigan, Ann Arbor, MI
AHRQ Grant No.: HS24385
Project Period: 09/30/15-12/31/19
Description: The goal of this learning lab was to implement novel methods to enhance cognition and communication among care providers to reduce hospital-acquired complications. The M-Safety Lab conducted two projects: Project 1 focused on developing a new monitoring system for hospitalized patients, and Project 2 addressed the common but understudied area of diagnostic error.

For Project 1, the aims were to:

1. Detect the presence and duration of vascular and urinary catheter use and report catheter presence and duration of use to clinicians to prompt timely removal of unnecessary catheters.
2. Identify areas of skin at risk for developing pressure ulcers (recently renamed by expert organizations as pressure injury) from exposure to intense and/or prolonged pressure, moisture, friction, and shear and report areas of at-risk skin to clinicians to prompt timely delivery of risk-reducing interventions such as patient repositioning and targeted skin care.

For Project 2, the aims were to:

1. Evaluate whether a meta-cognitive intervention using a structured checklist, a smartphone-based differential-diagnosis expander, and collective wisdom using a social media-based tool compared to a local "diagnostic board" can improve diagnostic and therapeutic decision making in patients who present with shortness of breath.
2. Examine the role of mindfulness, motivational interviewing, and architectural design in enhancing patient safety.

The M-Safety Lab’s achievements include the creation of a digital bedside display that shows patients’ catheter and wound information, which is pulled from the electronic medical record (EMR) every 10 minutes. The display improved provider's awareness of indwelling urinary catheters, central venous catheters, and pressure injuries (formerly called ‘pressure ulcers’). The improvement of provider awareness of indwelling urinary catheters was statistically significant when comparing the intervention period to pre-intervention period. The improvement in provider awareness of central venous catheters was significant when comparing intervention rooms to control rooms during the same timeframe.

The M-Safety Lab tested and validated a bed motion device that detects 84.8 percent of patients' motions correctly. It uses a non-contact sensor system to detect and report important patient motions, such as no motion (a sign that the patient is at risk of developing pressure injury) and rhythmic motion (for detection of seizure). Compared to commercially available pressure mattresses, this device showed improved performance and was less costly.

An intervention bundle combining mindfulness, changes to the physical space, diagnostic assistive tools, and an EMR-based checklist, did not improve diagnostic confidence or self-reported measures of mindfulness among physicians. Researchers concluded that more work is needed to develop interventions that would be beneficial to physicians and improve diagnostic accuracy.

To date, this PSLL's work has resulted in at least 14 peer-reviewed publications, with 90 citations in other publications.

A sample of this lab's publications is listed below. A longer description of its work and associated publications is available.

Publications

• Gupta A, et al. Understanding diagnostic reasoning using a case-based approach. Abstract published at Hospital Medicine 2018; April 8-11; Orlando, Fla. 
• Manojlovich M, et al. Contextual barriers to communication between physicians and nurses about appropriate catheter use. Am J Crit Care 2019;28(4):290-298.
• Quinn M, et al. Persistent barriers to timely catheter removal identified from clinical observations and interviews. Jt Comm J Qual Patient Saf 2020;46:99-108.

Failure to Rescue Patient Safety Learning Lab (FTR PSLL)

Principal Investigator: George Blike, M.D., Dartmouth-Hitchcock, Lebanon, NH
AHRQ Grant No.: HS24403
Project Period: 09/30/15-03/31/20

Description: The overall goal of this project was to create the ideal hospital rescue system. Mitigating failure to rescue (FTR) (i.e., death after a major complication) is critical to reducing mortality in hospitalized patients. Successful rescue hinges on early recognition and timely management of serious complications once they occur.

The project aims were to:

1. Target gaps in understanding the technology and human factors behind ideal risk assessment and risk surveillance.
2. Support early detection of nonpreventable complications and identify all the factors (individual, team, and technology) that define an ideal rescue system that effectively responds to and manages these complications.

The FTR PSLL comprehensively assessed the whole rescue system as opposed to fixing only subsystems, leading to the development of an FTR Event Mitigation System (i.e., policies and procedures, reporting mechanisms, tools, technologies, and other elements) that provides a roadmap for Dartmouth-Hitchcock. This roadmap and its interventions can also be used by other healthcare organizations to develop their own mitigation systems. Further, each intervention is accompanied by a concept model that shows stages of implementation for each organization's capability level.

The FTR PSLL’s design and evaluation of an enhanced surveillance monitoring system to detect early patient deterioration resulted in significantly improved key clinical elements related to early recognition of changes in patient state. It also increased patient monitoring time (rate ratio 1.22) while reducing data collection time by 28 percent.

To date, this PSLL’s work has resulted in at least 38 peer-reviewed journal publications, with nearly 600 citations in other publications; and presentations at institutions and conferences.

A sample of this PSLL's publications is listed below. A longer description of its work and associated publications is available.

Publications

• McGrath SP, et al. Failure to rescue event mitigation system assessment: a mixed-methods approach to analysis of complex adaptive systems [abstract]. Adv Health Care Manag 2019 Oct 24;18. Full text available at https://www.emerald.com/insight/content/doi/10.1108/S1474-823120190000018006/full/html.
• McGrath SP, et al. Improving patient safety and clinician workflow in the general care setting with enhanced surveillance monitoring. IEEE J Biomed Health Inform 2019;23(2):857-66.
• Umberfield E, et al. Using incident reports to assess communication failures and patient outcomes. Jt Comm J Qual Patient Saf 2019;45(6):406-13.

Institute for the Design of Environments Aligned for Patient Safety (IDEA4PS)

Principal Investigators: Ann Scheck McAlearney, Sc.D., M.S., The Ohio State University, Columbus, OH; formerly Susan Moffatt-Bruce, M.D., Royal College of Physicians and Surgeons of Canada, Ottawa
AHRQ Grant No.: HS024379
Project Period: 09/30/15-09/29/20
Description: The goal of the Institute for the Design of Environments Aligned for Patient Safety (IDEA4PS) was to improve workflows and information transfers in the healthcare environment.

The project aims were to:

1. Explore how cardiac alarms affect healthcare provider decision making.
2. Conduct surveillance of healthcare-acquired infections in real time.
3. Implement and evaluate secure messaging in electronic health records (EHRs).

The IDEA4PS Lab provided foundational infrastructure to connect stakeholders across Ohio State University and Wexner Medical Center to improve clinical practice by designing, testing, and exploring the types of information flows resulting in a safer healthcare work environment.

The work of IDEA4PS reduced the alarm burden of bedside monitors and the Secondary Alarm Notification System that is delivered on nurses' phones. These improvements allowed clinicians to focus on meaningful events over the din of background noise, enhancing the safety and quality of patient care. Further, the IDEA4PS Lab automated hospital-acquired infection surveillance to provide results in near real time to stakeholders and explored how the hospitalwide use of MyChart Bedside (MCB), an inpatient patient portal, affected the provider work system and processes. Subsequent changes included hiring technology navigators to assist with MCB provisioning and training both patients and clinicians on the use of MCB.

To date, this PSLL’s work has resulted in at least 70 peer-reviewed journal publications, with nearly 600 citations in other publications; nearly 90 presentations at institutions and conferences; and creation of a website (https://u.osu.edu/idea4ps).

A sample of this lab's publications is listed below. A longer description of its work and associated publications is available.

Publications

• McAlearney AS, et al. Empowering patients during hospitalization: perspectives on inpatient portal use. Appl Clin Inform 2019;10(1):103-12.
• McHaney-Lindstrom M, et al. Network analysis of intra-hospital transfers and hospital onset clostridium difficile infection. Health Info Libr J 2020;37(1):26-34.
• Rayo MF, et al. Using timbre to improve performance of larger auditory alarm sets. Ergonomics 2019;62(12):1617-29.

Making Acute Care More Patient-Centered

Principal Investigator: David Bates, M.D., Brigham & Women's Hospital, Boston, MA
AHRQ Grant No.: HS23535
Project Period: 09/30/14-09/29/19
Description: The goal of this learning laboratory was to develop tools to engage patients, families, and professional care team members by reliably identifying, assessing, and reducing patient safety threats in real time, before they manifested in actual harm.

The project aims were to:

1. Engage patients and their family caregivers in the design of health information technology (IT) tools to prevent patient falls and related injuries during an acute hospitalization.
2. Engage healthcare providers and patients in the design and development of a Patient Safety Checklist Tool to improve patient safety and quality outcomes, provider efficiency, and team communication.
3. Iteratively develop and evaluate the impact of a patient safety reporting system on patient safety and foster a learning health system.

This PSLL created and implemented an English and Spanish version of the Fall TIPS (Tailoring Interventions for Patient Safety) toolkit, which reduced falls by 25 percent in acute care hospitals. Today, the toolkit is used in more than 100 hospitals across the United States and internationally.

The lab launched the Patient SatisfActive® Model. This proactive, patient-centered care program uses a suite of health IT tools—patient safety dashboard, bedside display, and patient portal—to engage patients, families, and healthcare providers in improving patient safety. The creation of English and Spanish versions of a web-based, mobile-enabled application, called MySafeCare, is allowing patients and families to submit safety concerns and events in real time.

This PSLL's work has resulted in:

• At least 23 peer-reviewed journal publications, with more than 150 citations in other publications.
• More than 12 presentations at institutions and conferences across the United States to help other organizations bridge the gap between health IT and patient and provider needs.
• Two new websites (http://www.patientsafetyresearch.org/PSLL/home.html and http://www.falltips.org).
• Laminated posters and paper tools to meet the needs of diverse hospital environments.

A sample of their publications is listed below. A longer description of this lab’s work and associated publications is available.

Publications

• Dykes PC, et al. The Fall TIPS (Tailoring Interventions for Patient Safety) Program: a collaboration to end the persistent problem of patient falls. Nurse Leader 2019;17(4):365-70.
• Schnock KO, et al. Acute care patient portal intervention: portal use and patient activation. J Med Internet Res 2019;21(7): e13336.
• Couture B, et al. Applying user-centered design methods to the development of an mHealth application for use in the hospital setting by patients and care partners. Appl Clin Inform 2018;9(2):302-12.

Optimizing Safety of Mother and Neonate in a Mixed Methods Learning Laboratory

Principal Investigator: Louis Halamek, M.D., Stanford University, Stanford, CA
AHRQ Grant No.: HS023506
Project Period: 09/30/14-09/29/19
Description: The goal of this project was to establish a PSLL to advance patient safety for neonates and mothers before, during, and after delivery. The laboratory carried out four interrelated projects to:

1. Develop and test an optimal neonatal resuscitation data display.
2. Develop and test an optimal maternal data display.
3. Develop a process to recognize and prevent maternal clinical deterioration.
4. Develop the optimal physical design of a labor and delivery suite.

The project aims were to:

1. Study how flow of communication may affect patient safety. In this context, the flow of communication usually referred to the passing of information (in either direction) between clinicians and others, primarily other clinicians.
2. Examine how physical design elements may affect patient safety. These elements ranged from design of physical devices and organization of patient beds and storage spaces to layout of a patient room.
3. Develop a systematic method to study patient safety using a stepwise approach of problem analysis through qualitative research, design, development, implementation, and evaluation.

This PSLL developed, piloted, and tested innovative designs that resulted in the creation of:

• A maternal data display for the obstetrical team designed to improve situation awareness and enhance care in times of crisis. The display is linked to the electronic medical record (EMR) and provides easily recognizable visual cues (e.g., color-coding).
• A neonatal data display designed to show key neonatal physiologic variables, such as heart rate and minute-to-minute changes in hemoglobin-oxygen saturation, in a manner that supports decision making.
• A delayed cord-clamping cart (DCCC) designed to provide a stable platform for the neonate while still connected to the umbilical cord. A patent was filed for the DCCC in 2018.
• A labor and delivery room designed to provide comfort and privacy for women in labor that also meets the needs of healthcare professionals caring for these women and their newborns, even during a crisis. This room was designed to facilitate safe, effective, and efficient patient care.
• A pelvic lift cushion designed to provide a comfortable, effective, reusable, inexpensive, and portable option for these women when gynecological beds (with stirrups) were not available.

Knowledge gained from this PSLL has been disseminated via at least 10 peer-reviewed publications, presentations at multiple conferences, and several posters. A sample of their publications is listed below. A longer description of this lab’s work and associated publications is available.

Publications

• Sherman JP, et al. Understanding the heterogeneity of labor and delivery units: using design thinking methodology to assess environmental factors that contribute to safety in childbirth. Am J Perinatol 2020 May;37(6):638-46.
• Austin N, et al. Analyzing the heterogeneity of labor and delivery units: a quantitative analysis of space and design. PLoS One 2018;13(12):e0209339.
• Sherman J, et al. Medical device design education: identifying problems through observation and hands-on training. Des Technol Educ 2018;23(2):154-74.

Patient Imaging Quality and Safety Laboratory (PIQS Lab)

Principal Investigator: Leora Horwitz, M.D., New York University (NYU), New York, NY
AHRQ Grant No.: HS24376
Project Period: 09/30/15-08/31/20
Description: The goal of the PIQS Lab was to be a dynamic learning environment focused on improving safety and outcomes for patients. The multidisciplinary PIQS Lab connected experienced clinicians in the NYU departments of Radiology, Emergency Medicine, Medicine, Surgery, and Urology with operations, human factors, and management experts at NYU Langone Medical Center, the NYU Wagner School of Public Policy, and the NYU Stern School of Business and with design experts at the design firm IDEO.

The project aims were to:

1. Redesign the radiology ordering process to minimize inappropriate or unnecessary radiology tests.
2. Redesign the inpatient consultation process to improve patient safety.
3. Enhance the followup of radiology test results to improve patient outcomes.

The PIQS Lab examined radiology imaging failures through similar conceptual lenses of shared sense making (making sense of dynamic and ambiguous information without oversimplifying or ignoring discordant data) and sociotechnical systems (nature of the work, human-system interfaces, organization, environment, management). PIQS Lab faculty took a design and engineering approach to clinical redesign, beginning with in-depth problem analysis, then proceeded with design (brainstorming), development (prototyping), implementation, and evaluation phases.

The PIQS Lab developed and evaluated electronic health record (EHR)-automated Wells and Geneva risk score calculations of emergency department (ED) patients to determine: 1) their risk for pulmonary embolism (PE); and 2) whether a computed tomography pulmonary angiography (CTPA) should be ordered. Another achievement included the design, testing, and implementation of an EHR-based process improvement program for reporting and tracking incidental lung nodules (ILNs) at a large urban academic healthcare system.

This PSLL's work has resulted in at least 11 peer-reviewed journal publications, with 22 citations in other publications. A sample of their publications is listed below. A longer description of this lab’s work and associated publications is available.

Publications

• Garry K, et al. Patient experience with notification of radiology results: a comparison of direct communication and patient portal use. J Am Coll Radiol 2020;17(9):1130-8.
• Moore W, et al. Enhancing communication in radiology using a hybrid computer-human based system. Clin Imaging 2019;61:95-8.
• Simon E, et al. An evaluation of guideline-discordant ordering behavior for CT pulmonary angiography in the emergency department. J Am Coll Radiol 2019;16(8):1064-72.

Realizing Improved Patient Care Through Human-Centered Design in the Operating Room (RIPCHD.OR)

Principal Investigator: Anjali Joseph, Ph.D., Clemson University, Clemson, SC
AHRQ Grant No.: HS24380
Project Period: 09/30/15–08/31/21
Description: The overarching goal of RIPCHD.OR was to use an integrated systems engineering approach to develop ergonomic and safe operating room (OR) design solutions that improve staff workflow and perioperative outcomes.

The specific aims were to:

1. Improve the usability of anesthesia-related alarms in the OR.
2. Understand and improve traffic flow in the OR.
3. Develop a safer and more human-centered OR that supports technology integration and staff workflows.

RIPCHD.OR found that operating room size, design, and layout may create barriers to task performance, potentially contributing to the escalation of OR disruptions and errors. The project resulted in the development of a human-centered OR design concept that was then built as a high-fidelity physical mockup, implementation of OR design concepts in two new ambulatory surgery centers, and creation of the Safe OR Design Toolkit.

The toolkit gives multidisciplinary stakeholders an opportunity to understand the implications of design on safety in the OR and to interact with components in an OR environment through a 3D model. The postoccupancy evaluation of the new pediatric ambulatory surgery center demonstrated a reduction in disruptions and improved use of OR space.

To date, this PSLL's work has resulted in at least 24 peer-reviewed publications and more than 60 conference presentations. This PSLL has also been extensively cited in the popular media and in other journal publications.

A sample of RIPCHD.OR's publications is listed below. A longer description of this lab's work and associated publications is available.

Publications

• Joseph A, et al. Impact of surgical table orientation on flow disruptions and movement patterns during pediatric outpatient surgeries. Int J Environ Res Public Health 2021;18(15):8114.
• Taaffe K, et al. Proactive evaluation of an operating room prototype: a simulation-based modeling approach. J Patient Saf 2021;17(8):e1833-9.
• Joseph A, et al. Minor flow disruptions, traffic-related factors and their effect on major flow disruptions in the operating room. BMJ Qual Saf 2019;28(4):276-83.

Transdisciplinary Learning Lab to Eliminate Patient Harm and Reduce Waste

Principal Investigator: Adam Sapirstein, M.D., Johns Hopkins University, Baltimore, MD
AHRQ Grant No.: HS23553
Project Period: 09/30/14-03/29/19
Description: The goal of the Johns Hopkins Armstrong Institute Learning Lab was to use systems engineering methods to partner with patients, patients’ families, and others to eliminate preventable harm, optimize patient outcomes and experience, and reduce waste in healthcare.

The project aims were to:

1. Develop high-level design requirements for an ideal intensive care unit (ICU), using design thinking and systems engineering methods.
2. Leverage open-application programming interfaces to engineer interoperability between electronic health records and infusion pumps.
3. Develop and implement an indicator of unit-level stress in an engineered care system to predict and mitigate risk.

The lab achieved its aims in the following ways. It:

• Created a graphic roadmap for using the quality function deployment process to share with organizations that want to become high-reliability hospitals.
• Automated and validated the nurse-managed insulin infusion protocol at Johns Hopkins to illustrate the potential of optimizing safety, efficiency, and workload via system interoperability.
• Conducted the first application of statistical and machine learning techniques to develop a prediction model for the susceptibility of ICU patients to preventable harms.

This PSLL's work has resulted in at least six peer-reviewed journal publications, as well as posters and presentations at conferences across the United States.

A sample of their publications is listed below. A longer description of this lab’s work and associated publications is available.

Publications

• Matthews S, et al. Prioritizing healthcare solutions using the quality function deployment process. Crit Care Med 2019;47(1):661. 
• Griffiths SM, et al. Automated, web-based solution for bidirectional EHR-infusion pump communication. Biomed Instrum Technol 2019;53(1):30-7. 
• Romig M, et al. Developing a comprehensive model of intensive care unit processes: concept of operations. J Patient Saf 2018;14(4):187-92.

Yale Center for Healthcare Innovation, Redesign, and Learning (CHIRAL)

Principal Investigator: Sarwat Chaudhry, M.D., Yale University, New Haven, CT
AHRQ Grant No.: HS23554
Project Period: 09/30/14-09/29/19
Description: The goal of CHIRAL was to improve transitions of care. Patients being transferred from one setting to another or one clinical team to another are at increased risk for a host of failures. These include identification errors, delayed or missed diagnoses, redundant testing, treatment delays or errors, medication errors, and unexpected clinical deterioration.

The project aims were to:

1. Improve patient safety at the time of transition through redesign of transfers of patients into Yale New Haven Hospital (YNHH) from outside hospitals and emergency departments (EDs).
2. Redesign transfers within YNHH between the ED or intensive care unit (ICU) and general hospital units.
3. Redesign transfers out of YNHH to skilled nursing facilities (SNFs).

This PSLL created a framework to improve intra- and interhospital transfers that can guide the intervention work of departments within a hospital and at other facilities to address the domains of the transfer process, dimensions of the hospital context, and outcomes of transfers. To support this work, the lab developed the following products:

• Multiple survey instruments.
• A new measure tool to assess staff experience of intrahospital patient transfers.
• Real-time dashboards.
• Redesigned call-in templates in Epic.
• Training programs for staff.

CHIRAL conducted a multimodal study to improve the quality and safety of interhospital transfer for clinically ill patients. Results included a reduced mortality rate of patients with atraumatic intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH) from 29 percent before intervention to 11 percent postintervention.

This PSLL's work has resulted in:

• At least 10 peer-reviewed journal publications—4 in 2019—with nearly 30 citations in other publications.
• Nearly a dozen presentations at institutions and conferences across the United States.
• A new website (https://medicine.yale.edu/chiral/).
• Thirteen posters describing the studies conducted.

A sample of their publications is listed below. A longer description of this lab’s work and associated publications is available.

Publications

• Campbell Britton M, et al. Mapping the care transition from hospital to skilled nursing facility. J Eval Clin Pract 2020 Jun;26(3):786-90.
• Lord K, et al. Emergency department boarding and adverse hospitalization outcomes among patients admitted to a general medical service. Am J Emerg Med 2018;36(7):1246-48.
• Sather J, et al. Real-time surveys reveal important safety risks during interhospital care transitions for neurologic emergencies. Am J Med Qual 2019;34(1):53-8.

R18 Projects Funded in 2018

Acute Care Learning Laboratory—Reducing Threats to Diagnostic Fidelity in Critical Illness

Principal Investigator: Brian Pickering, M.B., B.Ch., M.Sc., Mayo Clinic, Rochester, MN
AHRQ Grant No.: HS26609
Project Period: 09/30/18-11/30/22
Description: The overall goal of this learning lab was to reduce the rate of diagnostic error or delay (DEOD) in acutely ill patients by establishing and using an in situ acute-hospital learning lab. Researchers engaged key stakeholders to identify threats to the diagnostic process and guide the design, development, testing, implementation, and evaluation of interventions targeting system vulnerabilities.

The specific aims were to:

1. Develop and validate automated phenotypes of DEOD that can be applied in near-real time to medical record data.
2. Engage stakeholders using mixed methods and systems engineering approaches to identify factors that contribute to DEOD, then design and develop applicable system-based interventions.
3. Evaluate the feasibility and preliminary effectiveness of learning lab interventions on the rate of DEOD in patients with emerging critical illness.

This PSLL developed a unique clinical informatics platform, Acute Care Multi-Patient Platform (Control Tower/AMP), that enables health information technology innovations to be developed with stakeholder input and implemented within the hospital. The resulting applications are built and supported locally, using agile methodologies and user-centered design principles.

A pilot study was conducted to determine if the Control Tower/AMP could reduce the time to clinical decision of 10 pairs of clinicians caring for acutely ill patients. Results showed that it significantly reduced the time to clinical task completion and clinician task load compared with the standard electronic medical record. While the Control Tower/AMP is not available for use by other organizations/institutions, it may be in the future.

To date, this PSLL’s work has resulted in at least 15 peer-reviewed journal publications, with more than 291 citations in other publications. A sample of the lab’s publications is listed below.

A longer description of its work and associated publications is available.

Publications

• Barwise A, et al. What contributes to diagnostic error or delay? A qualitative exploration across diverse acute care settings in the United States. J Patient Saf 2021;17(4):239-48.
• Herasevich S, et al. Evaluation of digital health strategy to support clinician-led critically ill patient population management: a randomized crossover study. Crit Care Explor 2023 May 3;5(5):e0909.
• Huang C, et al. Bedside clinicians’ perceptions on the contributing role of diagnostic errors in acutely ill patient presentation: a survey of academic and community practice. J Patient Saf 2022;18(2):e454-e462.
• Redmond S, et al. Contributors to diagnostic error or delay in the acute care setting: a survey of clinical stakeholders. Health Serv Insights 2022;15:11786329221123540.

Ambulatory Pediatric Safety Learning Lab

Principal Investigator: Kathleen Elizabeth Walsh, M.D., M.Sc., Boston Children’s Hospital, Boston, MA
Co-PI: Eric Kirkendall, M.B.I., M.D., Wake Forest School of Medicine, Winston-Salem, NC
AHRQ Grant No.: HS26644
Project Period: 09/30/18-09/29/23
Description: The overarching goal of this lab was to reduce medication errors and treatment delays for children with two types of chronic conditions: type 1 diabetes (T1D) and autism spectrum disorder (ASD).

The specific aims were to:

1. Redesign processes for adjustment of medication dosing based on clinical information gathered by the patient/family to prevent medication errors. (This process was studied in children with T1D.)
2. Create patient/family medication monitoring processes and communication with the clinic to prevent adverse drug events. (This process was studied in children with ASD on antipsychotics.)
3. Design a workflow to plan for, detect, and promptly manage serious illness among children with chronic conditions at home. (This process was studied in both populations.)

The lab comprised a transdisciplinary team of parents, safety researchers, and physicians. The team process mapped data collected from in-home medication review, medication administration observation, parent surveys, simulations, and failure modes and effects analysis (FMEA) to design interventions. Researchers found that patient and family knowledge and skillsets in dealing with these conditions varied considerably. For example, more than half of the T1D patients involved in home visits had medication errors, at a rate of 31 per 100 medications. 

For the ASD cohort, parents had difficulty distinguishing between the adverse effects of medications and behavioral variations/escalations associated with ASD. This challenge led researchers to design, develop, implement, and evaluate personalized care and communication approaches for each cohort. 

For the T1D cohort, web-based home care guidelines, a ketone calculator with instructions, and a “chatbox” dialogue were developed for parents to use when their children were ill. In addition, simulation scenarios were designed to create an entire framework for assessing parents’ knowledge and the safety of their current processes. This framework provided researchers with an evaluation tool and opportunities for patients and parents to improve their understanding. The framework is being incorporated into the routine educational programs at Cincinnati Children’s Hospital and can be further built upon and disseminated via conferences, articles, and electronic resources and tools. 

To date, this PSLL’s work has resulted in at least five peer-reviewed journal publications that have been cited 55 times in other publications, along with four presentations at conferences during the project period. 

A sample of this lab’s publications is listed below. A longer description of this lab’s work and associated publications is available. 

Publications 

1. Brady PW, et al. Promoting action on diagnostic safety: The Safer Dx Checklist. Jt Comm J Qual Patient Saf 2022;48(11):559-560. 
2. Kirkendall ES, et al. Safer type 1 diabetes care at home: SEIPS-based process mapping with parents and clinicians. Pediatr Qual Saf 2023 May/June;8(3):e649. 
3. Marshall TL, et al. Diagnostic error in pediatrics: a narrative review. Pediatrics 2022 Mar 1;149(Suppl 3):e2020045948D.

Cancer Patient Safety Learning Laboratory (CaPSLL): Preventing Clinical Deterioration in Outpatients

Principal Investigator: Matthew Weinger, M.D., Vanderbilt University Medical Center, Nashville, TN
Co-PI: Daniel France, M.P.H., Ph.D., Vanderbilt University School of Engineering, Nashville, TN
AHRQ Grant No.: HS26616
Project Period: 09/30/18-09/29/23
Description: The overall goal of CaPSLL was to improve detection and response to clinical deterioration in cancer outpatients, who often suffer the effects of adverse events and disease progression.

The specific aims were to:

1. Create and refine software tools and a predictive model for a surveillance-and-response system to prevent harm from unexpected all-cause clinical deterioration in outpatients receiving cancer treatment.
2. Create and refine processes and training that engage patients and their caregivers as active and reliable participants in detecting and reporting potential clinical deterioration.
3. Implement in the operational environment and formally evaluate the integrated detection and response tools and processes.

CaPSLL used a human-centered integrated approach to successfully predict cancer outpatients’ 7-day risk of experiencing unplanned treatment events (UTEs), such as readmissions, emergency department visits, and cancer therapy changes. To start, lab researchers observed 100 patient encounters over 80 hours and conducted 17 interviews with oncologists to understand ambulatory cancer care and the processes of detecting deterioration. 

This approach led to using the following technological mechanisms, which make up the CaPSLL surveillance-and-risk prediction system (one of only a few such systems for cancer patients): 

• Fitbit wristwatches to collect vitals and activity data from patients (e.g., calories, sleep, steps walked, resting heartrate). 
• Smartphone app for patients/caregivers to answer questions weekly (i.e., patient-reported outcome measures [PROMs]). 
• Google Maps data from smartphones to monitor patients’ location. 
• Clinical data from the electronic health record (EHR).

Of all the data methods, the PROMs and clinical EHR data (used together) were the most reliable in predicting the 7-day risk of UTEs among 50 patients undergoing ambulatory cancer treatments over 3 to 6 months. The Fitbit and Google Maps methods were less successful due to several barriers, such as the COVID-19 pandemic, the lengthy process of educating patients and setting up devices, and the burden of daily device management (e.g., wearing, charging, synching smartphones). Despite the barriers, the accessibility and affordability of these technological tools make them, according to the researchers, worthwhile in monitoring cancer outpatients; however, more research needs to be conducted. 

To date, this PSLL’s work has resulted in at least three peer-reviewed journal publications that have been cited 139 times in other publications, along with 20 scientific abstracts or posters at local and national conferences during the project period. 

A sample of this lab’s publications is listed below. A longer description of this lab’s work and associated publications is available. 

Publications 

1. France DJ, et al. Development and validation of a surveillance and risk prediction system for clinical deterioration in ambulatory cancer. ACI Open 2024 Sep. 
2. France DJ, et al. Using Fitbit data to predict clinical deterioration and unplanned treatment events in cancer outpatients. JCO 2021;39(15):e13560. 
3. Salwei ME, et al. Preventing clinical deterioration in cancer outpatients: human centered design of a predictive model and response system [abstract]. JCO 2022;40(16):e13567.

Connected Emergency Care Patient Safety Learning Lab (CEC PSLL)

Principal Investigator: Jeremiah Hinson, M.D., Ph.D., Johns Hopkins University, Baltimore, MD; formerly Scott Levin, M.S., Ph.D., Johns Hopkins University, Baltimore, MD
AHRQ Grant No.: HS26640
Project Period: 09/30/18-12/31/23
Description: The goal of CEC PSLL was to improve care in the emergency department (ED) by designing technological tools such as clinical decision support (CDS) that further connected physicians to patients’ pre-, post-, and intra-encounters.

The specific aims are to:

1. Optimize diagnostic performance for patients with suspected respiratory infection.
2. Increase the specificity of antibiotic treatment for patients with respiratory infection.
3. Improve transition of care outcomes after the ED encounter was complete by reducing: (a) unnecessary hospitalizations and sudden care-level changes for those admitted; and (b) 30-day postencounter acute care use for those discharged.

CEC PSLL’s multidisciplinary team of physicians, nurses, pharmacists, administrators, and engineers followed a five-phase innovation cycle. Researchers used agile methodology to create a data infrastructure and resources to problem solve critical gaps in care, particularly in the management of infectious diseases. 

When COVID-19 emerged in 2020, the lab shifted its focus to make important contributions with its data science assets, including a data repository derived from electronic health records, to study respiratory infections. This adjustment allowed researchers to meaningfully support institutional and regional decision making during the pandemic. 

The lab’s data architecture served as the backbone for this project and helped develop machine learning models that estimated short-term risk of clinical deterioration. These data-informed CDS tools paved the way for more informed, efficient, and equitable healthcare practices. Researchers also used the lab’s data science assets to understand the influence of race and socioeconomic status on antibiotic prescribing for acute respiratory infections in the ED. 

To date, this PSLL’s work has resulted in at least 18 peer-reviewed publications that have been cited more than 230 times in other publications, as well as posters and presentations at conferences across the United States. 

A sample of this lab’s publications is listed below. A longer description of its work and associated publications is available. 

Publications 

1. Ehmann MR, et al. Epidemiology and clinical outcomes of community-acquired acute kidney injury in the emergency department: a multisite retrospective cohort study. Am J Kidney Dis 2024;83(6):762-771.e1. 
2. Hinson JS, et al. Multisite development and validation of machine learning models to predict severe outcomes and guide decision‐making for emergency department patients with influenza. J Am Coll Emerg Physicians Open 2024 Apr;5(2):e13117. 
3. Stonko DP, et al. A pilot machine learning study using trauma admission data to identify risk for high length of stay. Surg Innov 2023 Jun;30(3):356-365.

Engineering Safe Care Journeys for Vulnerable Older Adults

Principal Investigator: Maureen Smith, M.D., M.P.H., Ph.D., University of Wisconsin (UW), Madison, WI; formerly Pascale Carayon, Ph.D., University of Wisconsin (UW), Madison, WI
Co-PI: Nicole Werner, Ph.D., University of Indiana, Bloomington, IN
AHRQ Grant No.: HS26624
Project Period: 09/30/18-07/31/23
Description: The overall goal of this lab was to provide older adults with a safe journey in the emergency department (ED) by developing a system of care that provides opportunities to detect and recover from errors, anticipate patient safety issues in subsequent steps of the journey, and improve communication and coordination.

The specific aims were to:

1. Analyze, design, develop, implement, and evaluate a system of care (identified as the patient safety passport) that supports the safe journey of older adults after ED presentation.
2. Develop a transdisciplinary PSLL aimed at engineering safe care journeys for vulnerable patients, including older adults.

The lab’s transdisciplinary team of engineers, health services researchers, nurses, physicians, and pharmacists collaborated with a health system composed of academic and community Eds. They process mapped older patients’ journey in the ED and identified barriers and facilitators of these processes, disposition decision making, and care transitions. 

This research led to the development of a “patient safety passport.” Like a passport to travel between countries, the patient safety passport is “checked” at each transition point and facilitates recognition and anticipation of the older adult’s specific safety needs. 

The passport consists of three interventions: 

• The ED discharge intervention targets the journey from the ED to home and includes four components: medication self-management, patient care plan, followup, and red flags. 
• The ED-to-skilled nursing facility (SNF) antibiotic stewardship intervention automatically identifies older adult residents of SNFs who present to the ED. This intervention triggers a series of actions aimed at increasing communication between the ED and SNF to improve antibiotic stewardship for older adults with a suspected urinary tract infection. 
• The patient journey map intervention is designed for patients and caregivers during the ED visit. It is divided into three segments that represent different stages in the patient’s ED experience: intake and triage; assessment, diagnosis, and next steps; and discharge. 

To date, this PSLL’s work has resulted in at least 16 peer-reviewed publications, with 224 citations in other publications, as well as posters and presentations at conferences across the United States. 

A sample of this lab’s publications is listed below. A longer description of its work and associated publications is available. 

Publications 

1. Barton HJ, et al. Evaluating the usability of an emergency department after visit summary: staged heuristic evaluation. JMIR Hum Factors 2023 Mar 9;10(1):e43729. 
2. Hoonakker PL, et al. Satisfaction of older patients with emergency department care: psychometric properties and construct validity of the consumer emergency care satisfaction scale. J Nurs Care Qual 2023 Jul-Sep;38(3):256-263. 
3. Werner NE, et al. Disparate perspectives: exploring healthcare professionals’ misaligned mental models of older adults’ transitions of care between the emergency department and skilled nursing facility. Appl Ergon 2021 Oct;96:103509. 
4. Wust KL, et al. Older adult patients and care partners as knowledge brokers in fragmented health care. Hum Factors 2024;66(3):701-713.

Identifying and Reducing Errors in Perioperative Anesthesia Medication Delivery

Principal Investigator: Ken Catchpole, Ph.D., Medical University of South Carolina, Charleston, SC
Co-PI: James Abernathy, M.D., M.P.H., Johns Hopkins University, Baltimore, MD
AHRQ Grant No.: HS26625
Project Period: 09/30/18-07/31/23
Description: This lab’s overarching goal was to reduce anesthesia medication errors by assessing the anesthesia medication work system and identifying characteristics of technologies and interventions that would feasibly improve patient safety.

The specific aims were to:

1. Explore solutions to failures in diagnosis, selection, and prescribing of intraoperative anesthesia medication.
2. Develop methods to reduce failures in the preparation, administration, and recording of intraoperative anesthesia medication.
3. Understand and improve workspace design and safety culture to influence anesthesia medication selection and delivery.

The learning lab found that “medication error” is defined in multiple ways, focusing solely on patient outcome, causation, or both. Multiple definitions can lead to problems synthesizing, interpreting, and engaging in overall sense making about anesthesia medication safety. Specifically, this range of definitions leads to confusion between harm and its causes. 

Through interviews and observations, researchers explored how decisions about anesthesia medication were informed by various devices, technologies, and information sources and how practitioners addressed unreliable information. The research team also found wide variability in decision-making strategies that can limit standardized approaches to medication safety. They studied how syringes are used, stored, and moved within an operating room (OR) and the limitations of incident reporting for determining causation. The team identified cramped workspaces, limited access to the patient and equipment, and lack of standardization across non-OR anesthesia settings as risk factors for anesthesia medication delivery. 

These findings led to developing anesthesia workspace guidelines and OR workspace configurations presented through virtual reality. Of three configurations, one was traditional and two were new. An evaluation of the configurations showed that the new ones significantly enhanced situational awareness, allowed continuous visual monitoring of the patient, and provided ample horizontal workspace for tasks. This success paves the way for a more efficient and patient-focused anesthesia delivery system. 

To date, this PSLL’s work has resulted in at least 22 peer-reviewed publications that have been cited nearly 200 times in other publications, as well as posters and presentations at conferences in the United States and internationally. 

A sample of this lab’s publications is listed below. A longer description of its work and associated publications is available. 

Publications 

1. Mohammadi Gorji S, et al. Anesthesia workspaces for safe medication practices: design guidelines. HERD 2024;17(1):64-83. 
2. Neyens DM, et al. The movement of syringes and medication during anesthesiology delivery: an observational study in laparoscopic surgeries. Appl Ergon 2024 Jul 1;118:104263. 
3. Sims H, et al. The impact of a novel syringe organizational hub on operating room workflow during a surgical case. Jt Comm J Qual Patient Saf 2024 Jul;50(7):542-544.

Improving Diagnosis in Emergency and Acute Care: A Learning Laboratory (IDEA-LL)

Principal Investigator: Prashant Mahajan, M.D., M.P.H., M.B.A., University of Michigan, Ann Arbor, MI
Co-PIs: Kalyan Pasupathy, Ph.D., University of Illinois, Chicago, IL; Hardeep Singh, M.D., M.P.H., Department of Veterans Affairs, Houston, TX
AHRQ Grant No.: HS26622
Project Period: 09/30/18-07/31/23
Description: IDEA-LL planned to address diagnostic decision making, associated cognitive processes, and uncertainty in Emergency Department (EDs). To reduce diagnostic errors in the ED, researchers used methods that illustrated the dynamics of human-system interaction during diagnostic processes. The lab’s goal was to create a program for diagnostic safety surveillance and intervention using actionable, patient-centered data obtained from both frontlines of care and EHRs.

The specific aims were to:

1. Understand the detailed process of diagnostic decision making and identify potential factors that lead to diagnostic errors using mixed methods-grounded theory (i.e., combining qualitative data [participant observations, indepth participant interviews] and mining of historical data).
2. Develop a comprehensive list of patient, provider/care team, and system-level contributory factors and identify interventions to be studied using consensus methods.
3. Test the effectiveness and impact of the interventions at the four EDs using mixed methods (i.e., quantitative and qualitative measures).

IDEA-LL used multidisciplinary approaches to design, implement, and evaluate interventions to improve diagnostic safety. The investigative team, led by a unique physician-engineer partnership, formed a transdisciplinary environment of clinicians, nurses, patients, engineers, informaticians, and designers as an integral aspect of the learning laboratory to address both pediatric and adult emergency care in academic and community EDs.

Improving the Safety of Diagnosis and Therapy in the Inpatient Setting

Principal Investigator: Anuj K. Dalal, M.D., and David Bates, M.D., MSc., Brigham & Women’s Hospital, Boston, MA
AHRQ Grant No.: HS26613
Project Period: 09/01/18-06/30/22
Description: The overall goal of this learning lab was to improve diagnostic safety and link diagnosis to the correct treatment in acute care. To address this overall issue, the lab used rigorous systems engineering and human factors methods to guide its approach.

The specific aims were to conduct:

1. Problem analysis using systems engineering methods to analyze the problem of diagnostic and therapeutic error and identify system and cognitive factors for a set of morbid, costly common conditions and undifferentiated symptoms.
2. Design and development using human factors methods and rapid, iterative prototyping of interventions to engage care teams and patients/caregivers to ensure treatment trajectories match the anticipated course for working diagnoses or symptoms, ensuring alignment with patient and clinician expectations.
3. Implementation and evaluation by conducting pilot tests, training clinical staff, implementing interventions in the acute care setting, assessing the impact on diagnostic errors that lead to patient harm, and performing quantitative and qualitative evaluations.

This PSLL created multiple interventions to improve diagnostic safety among hospitalized patients. They include:

• A Diagnostic Timeout (DTO) to assist clinicians in reassessing the diagnosis of patients (i.e., inside or outside their hospital rooms) when risk for diagnostic error (DE) or diagnostic uncertainty is high. It comes in the form of a pocket card, app, and Smart Phrase.
• A Diagnostic Safety Educational Curriculum that comprises short, animated video tutorials delivered online to engage clinician learners in using the DTO to address diagnostic uncertainty and mitigate risk of DE. An interactive newsletter was also created.
• A Diagnostic Safety Column (DSC) and DE Predictive Algorithm housed in the electronic health record and modeled as a DE risk score (i.e., (a₁X₁ + a₂X₂ + a₃X₃ + a₄X₄ … + a_nX_n). In this risk score, X_n represents baseline risk factors and in-hospital clinical factors, as well as the coefficient (weight) of each independent variable. Configurable parameters (i.e., variables, weights) enable adjusted baseline risk estimates in real time based on new clinician data collected during hospitalization.
• A Patient Diagnostic Questionnaire (PDQ) that aligns with the “Patient Experience” Safer Dx process dimension to assess patients’ understanding of their diagnosis at optimal times so their feedback can be relayed back to the care team.

Leading to the creation of these interventions, researchers first adapted validated tools (Safer Dx, DEER Taxonomy) to pinpoint 44 diagnostic process failures (DPFs) in a cohort of representative cases. Most of the significant DPFs (63.3%) occurred during the “Diagnostic Information and Patient Follow-up” and “Patient and Provider Encounter and Initial Assessment” phases.

Next, researchers developed a structured case review process that was validated against their institution’s mortality review process. Using this process, they found that harmful DEs were common, occurring in about 7% of hospitalized patients, especially among high-risk patients (i.e., those who were transferred unexpectedly to intensive care, died within 90 days of hospitalization, or had complex clinical events).

Overall, researchers found their interventions resulted in trends toward clinically important improvement, particularly for high-risk patients. They noted that because of COVID-19, their implementation was not as robust as they had hoped. However, they found the DTO, as well as the interactive implementation materials (training workshops, interactive newsletters), were well received by clinicians. Researchers recommended that future evaluations include concurrent (e.g., cluster-randomized) trials to reduce confounding by temporal trends due to factors such as the COVID-19 pandemic.

To date, this PSLL’s work has resulted in at least 8 peer-reviewed journal publications, with 11 citations in other publications. The team has also been working to disseminate the structured care review process and interventions as part of several AHRQ-funded efforts (UPSIDE, ADEPT).

A sample of this lab’s publications is listed below. A longer description of its work and associated publications is available.

Publications

• Dalal AK, et al. Identifying and classifying diagnostic errors in acute care across hospitals: Early lessons from the Utility of Predictive Systems in Diagnostic Errors (UPSIDE) study. J Hosp Med 2023;10.1002/jhm.13136.
• Garber A, et al. Developing, pilot testing, and refining requirements for 3 EHR-integrated interventions to improve diagnostic safety in acute care: a user-centered approach. JAMIA Open 2023;6(2):ooad031. Published 2023 May 10.
• Schnock KO, et al. Providers' and Patients' Perspectives on Diagnostic Errors in the Acute Care Setting. Jt Comm J Qual Patient Saf 2023;49(2):89-97. 

Pediatric Patient Safety Learning Laboratory to Reengineer Continuous Physiologic Monitoring Systems

Principal Investigator: Christopher Bonafide, M.D., M.S.C.E., Children’s Hospital of Philadelphia (CHOP), Philadelphia, PA
AHRQ Grant No.: HS26620
Project Period: 09/30/18-07/31/23
Description: This lab’s goal was to reengineer physiologic monitoring of children to make alarms more informative.

The specific aims were to:

1. Reengineer the system of monitoring hospitalized children in acute care wards, focusing on reducing noninformative alarms and accelerating nurse responses to critical events.
2. Reengineer the system of monitoring infants with bronchopulmonary dysplasia at home, focusing on reducing noninformative hypoxemia alarms and improving clinicians’ access to usable longitudinal pulse oximetry data to inform supplemental oxygen treatment.

This PSLL comprised a diverse group of physicians, nurses, scientists, engineers, designers, and support staff. They followed a planned, five-step phased approach to understand physiologic monitoring problems and iteratively test solutions in the home and hospital settings. 

For the hospital setting, the lab reconfigured and standardized alarm limit defaults across all medical-surgical units at CHOP, updated policies and provider order entry, educated providers, and integrated new alarm system technology. These interventions resulted in a 21 percent reduction in alarm notifications and a 59 percent improvement in response to alarms. In addition, the lab designed an alarm manager to actively filter nonactionable alarms by suppressing them before they reached the bedside nurse. It also amplified actionable, critical alarms by directly calling the nurse when actionable alarms occurred. 

For the home setting, the lab provided clinical decision support in a letter detailing the required elements of home oximeter ordering, along with more liberal age-specific default alarm limits. This information resulted in a significant decrease in the median low pulse oximetry limit and a significant increase in home oximetry order completeness. 

Other tools and resources include: 

• National guidance for pediatric monitoring. 
• The CHOP Center for Healthcare Quality and Analytics Patient Monitoring Taskforce. 
• Integration of clinical decision support into the electronic health record. 
• Optimal notification tones for pulse oximetry alarms. 
• In situ simulation of responses to alarms. 

To date, this PSLL’s work has resulted in two national awards and at least 16 peer-reviewed journal publications that have been cited 115 times in other publications. 

Below is a sample of the lab’s publications. A longer description of its work and associated publications is available. 

Publications 

1. Craig S, et al. Characteristics of emergency room and hospital encounters resulting from consumer home monitors. Hosp Pediatr 2022;12(7):e239-e244. 
2. Herrick H, et al. Clinical decision support for pediatric home pulse oximetry orders. ESS Open Archive 2023 Jul 11. 
3. McLoone M, et al. Observing sources of system resilience using in situ alarm simulations. J Hosp Med 2023;18(11):994-998.

R18 Projects Funded in 2019

Open Wide Learning Lab (OWLL): Improving Patient Safety in Dentistry

Principal Investigator: Muhammad Walji, Ph.D., University of Texas Health Science Center at Houston, Houston, TX
AHRQ Grant No.: HS027268
Project Period: 09/09/19-08/31/24
Description: The OWLL addressed the problem of adverse events (AEs) in dentistry—a field that routinely performs highly technical and risky procedures in complex environments—using systems engineering to identify and reduce potential threats and improve patient safety.

Investigators applied the lessons learned from two previous projects (R01 DE022628 and R01 HS024406) that supported: (1) the development and testing of a Patient Safety Toolkit and creation of a data repository to collect, organize, and classify data; and (2) large-scale chart reviews to determine the incidence of dental AEs and impact on populations facing disparities.

The project’s aims were to:

1. Identify and understand the contributing factors (conduct problem analysis) for commonly occurring dental AEs.
2. Design and develop improvement strategies to prevent AEs using a systems-based human-centered design process.
3. Implement and evaluate improvement strategies at two institutions and evaluate their impact on proximal and distal outcomes using a stepped-wedge, clustered randomized control trial.

With current funding, the OWLL identified, assessed, and addressed patient safety incidents at two large academic dental institutions in Texas and California, where investigators systematically identified threats to dental patient safety and iteratively tested improvement strategies to prevent them.

Patient Safety Learning Laboratory to Enhance the Value and Safety of Neonatal Interfacility Transfers in a Regional Care Network

Principal Investigator: Rachel Umoren, MBBCH, M.S., University of Washington, Seattle, WA
AHRQ Grant No.: HS027259
Project Period: 09/03/19-08/31/23
Description: The lab’s overarching goal was to optimize clinical workflow and transport communication systems to enhance the value and safety of neonatal transport in a multistate regional network.

The project’s aims were to:

1. Codesign clinical workflow processes to optimize regional neonatal consultation, triage, and transport. 
2. Engineer a novel transport monitoring and communication system to improve information flow within the transport environment. 
3. Develop a system for timely and accurate online tracking of patient safety data during neonatal transport.

The lab comprised pediatric physicians and nurses, systems engineers, simulation experts, and hospital transport staff. It undertook a five-stage innovation cycle (i.e., problem analysis, design, development, implementation, and evaluation) to identify and model the current and ideal state for neonatal interfacility transfers among hospitals in the regional network. 

Although its work was limited due to COVID-19 pandemic restrictions, the lab analyzed: 

• Transport team factors (e.g., team and mode of transport, transport time and arrival on scene, departure, arrival at receiving facility) and procedures performed. 
• Call patterns and durations of referral calls (using transport call logs) and transportation routes and task time distributions (using neonatal transport data). 
• Patient factors: 
  • Age, weight, gestation.
  • Vital signs (temperature, heart rate, respiratory rate).
  • Primary diagnosis (known at transport). 
  • Severity of illness.
  • Hypotension (blood pressure, use of vasopressors, volume administration, establishment of arterial access). 
  • Acidosis (pH, base deficit, volume resuscitation, bicarbonate or acetate administration).
  • Respiratory failure (oxygen saturation, partial pressures of oxygen and carbon dioxide, mode of respiratory support, type of artificial airway). 
• Patient outcomes: length of stay (total hospital days, intensive care unit days, ventilator days) and mortality (transport, 12 hours, 7 days, overall). 
• Transport team procedures and guidelines, including decision support tools and pre-/post-procedural communication with medical control physicians.

This work led to the development of the Neonatal Transport Discrete Event Simulation (DES) model, encompassing communication and transportation submodels and several referring and receiving facilities to represent hospital capacity. Researchers conducted simulation experiments to investigate the effects of patient attributes, bed capacity, communication process, and ambulance resource allocation on bedside wait times and total transportation time. 

A simulated Transport Communication and Monitoring (TCAM) application was also developed and tested in simulations to evaluate its impact on critical factors influencing communication, decision making, and workflow on transports. Such factors include staffing, bed availability at receiving and referring hospitals in a regional network, regional weather, and prevailing traffic patterns to support medical control physicians and transport teams. 

To date, this PSLL’s work has resulted in at least eight peer-reviewed journal publications, with 20 citations in other publications, as well as presentations at conferences in the United States and Canada. 

A sample of the lab’s publications is listed below. A longer description of its work and associated publications is available. 

Publications 

1. Cook M, et al. Health professional perspectives on communication and monitoring during interfacility neonatal transport. Proc Hum Factors Ergon Soc Annu Meet 2023;67(1):79-85. 
2. Li L, et al. A simulation-based approach to analysing delays in the transport of critically ill neonates. Health Syst 2024 Aug 23:1-16. 
3. McKissic D, et al. A Description of medications and intravenous fluids used during neonatal transport by a regional pediatric critical care team. Air Med J 2024 May 1;43(3):236-240. 
4. Riley T, et al. Disparities in access to healthcare services in a regional neonatal transport network. Int J Ind Ergonom 2024 Jan 1;99:103526.

PROMIS Learning Lab: Partnership in Resilience for Medication Safety

Principal Investigator: Yan Xiao, Ph.D., University of Texas at Arlington, TX
AHRQ Grant No.: HS027277
Project Period: 09/11/19-03/31/25
Description: The objective of the PROMIS Learning Lab is to reduce preventable medication-related harm using behavioral science via a partnership approach, especially among patients 65 and older. A systems engineering approach will be used at two in situ lab clinics from a practice-based research network, where problem analysis, design, and evaluation will be conducted.

The project’s aims are to:

1. Identify and define primary care work system design requirements to address commonly occurring medication-related safety hazards and to enable resilient performance through partnership.
2. Improve the value of primary care services using work system design strategies, such as informational tools, task redesign, and space layout, to enable and build capacity for resilient performance.
3. Implement and evaluate redesign work system components at two primary care clinics.

The PROMIS Lab includes community partners to involve older adults and their caregivers in design cycles, and a network of informant clinics for observations and learning. Investigators will provide extensive multidisciplinary expertise, including geriatric nursing, systems engineering, behavioral economics, and healthcare simulation, as well as offer expertise in pharmacology, family medicine, and health services research. Impact will be insights along with innovative yet practical tools, design guidelines, and collaboration support strategies for teamwork beyond clinic walls.

R18 Closed Loop Diagnostics: AHRQ R18 Patient Safety Learning Laboratories

Principal Investigator: Russell Phillips, M.D., Harvard University Medical School, Boston, MA
Co-PIs: James Benneyan, Ph.D., Northeastern University, Boston, MA; Gordon Schiff, M.D., Brigham & Women’s Hospital, Boston, MA
AHRQ Grant No.: HS027282
Project Period: 09/10/19-09/29/24
Description: This project addressed diagnostic errors in primary care often caused by failures to follow up (close the loop) on diagnostic tests, referrals, and symptoms. This research used innovative, evidence-based systems engineering methods that have been used to develop highly reliable and robust processes in other industries but had not yet been widely adopted in healthcare. Key innovations of this project were the use of high reliability and human factors methods; inclusion of patients and clinicians from other practices throughout the engineering process; and combined use of statistical, qualitative, and computer modeling methods to estimate improvements both in the primary site and more broadly.

More specifically, the aims of this project were to:

1. Design, develop, and refine highly reliable closed loop systems for diagnostic tests and referrals that ensure these occur within clinically and patient-important timeframes.
2. Design, develop, and refine a highly reliable closed loop symptom-monitoring system to ensure clinicians receive information about evolving symptoms of concern.
3. Ensure broader generalizability of results of Aims 1 and 2 by ensuring these new processes are effective in a community health center in an underserved community, a large telemedicine system, and a representative range of simulated other health system settings and populations.

Projected results included increased completion of high-risk diagnostic tests, referrals, and identification of concerning symptoms, in turn resulting in reduced diagnostic errors, negative health outcomes, and associated costs. Learning outcomes included improved understanding of closed loop diagnostic and monitoring problems in primary care, patient engagement in solutions to such problems, and utility of systems engineering for important healthcare problems.

Re-engineering for Accurate, Timely, and Communicated Diagnosis of Cardiovascular Disease in Women (DREAM Lab)

Principal Investigator: Kristen E. Miller, Dr.P.H., CPPS, MedStar MedStar Health Research Institute, Hyattsville, MD
Co-PI: John Yosaitis, M.D., MedStar Health, Washington, DC
AHRQ Grant No.: HS027280
Project Period: 09/12/19-09/29/24
Description: The goal of this learning lab was to apply a mixed-methods systems engineering approach to understand the complex interplay of factors contributing to cardiovascular disease (CVD) diagnostic error in women in the ambulatory care setting and to codesign and evaluate adaptive solutions.

Investigators used a population health approach to evaluate factors including but not limited to the physical environment, social and economic determinants, clinical care, health IT, and health behaviors. Transdisciplinary teams leveraging systems engineering that uses novel tactics and rigorous evaluation techniques were positioned to successfully mitigate this complex problem.

The learning lab had the following specific aims:

1. Identify the contributing factors leading to diagnostic errors and inappropriate clinical management of CVD in women.
2. Develop pragmatic performance and improvement measures.
3. Propose, prioritize, and co-design human-centered solutions to mitigate diagnostic risk.
4. Evaluate the structure, process, and outcome effects of human-centered solutions on CVD diagnosis, clinical management, and communication in simulated and clinical environments.

This work set up a clear pathway toward clinical implementation by systematically evaluating human-centered solutions in a simulated environment with input from practicing clinicians and patients as the end-users, followed by pilot testing promising solutions in the clinical environment.

Re-engineering Postnatal Unit Care and the Transition Home to Reduce Perinatal Morbidity and Mortality

Principal Investigator: Alison Stuebe, M.D., M.Sc., University of North Carolina, Chapel Hill, NC
Co-PIs: Kristin Tully, Ph.D., University of North Carolina, Chapel Hill, NC; Emily Patterson, Ph.D., The Ohio State University, Columbus, OH
AHRQ Grant No.: HS027260
Project Period: 08/30/19-09/29/24
Description: The goal of this learning lab was to identify underlying contributors to postnatal morbidity and mortality and codevelop more effective, sustainable, and scalable postnatal care. To achieve this goal, investigators redesigned systems of clinical maternity care by defining postnatal unit problems and creating an innovative, individualized delivery system for more effective mother-infant management during postnatal hospitalization and the discharge transition to home.

The University of North Carolina at Chapel Hill, in partnership with Systems Engineering at The Ohio State University and the North Carolina State University College of Design, evaluated their systems redesign using the primary outcome of a 20 percent reduction in ED visits and readmission from discharge to 90 days postpartum for mothers and infants. To achieve this reduction, investigators planned to improve patient safety and care value in three intersecting domains: Mother/Baby Recovery, Precision Clinical Care, and Care Transition from Hospital to Home.

The specific aims were to:

1. Define priority areas by using mixed methods: Investigators will analyze current processes and procedures for maternal-infant dyadic evaluation and management during the postnatal unit stay and discharge transition through the lens of mothers, clinicians, EHR data, and other key stakeholders.
2. Conduct iterative prototyping and evaluation of interventions: Building on identified design seeds, investigators will alternate between idea generation and evaluation until prototypes emerge that can be implemented and assessed in a low-stakes laboratory setting for refinement and then in the clinical setting.
3. Implement and disseminate: In this phase, investigators will use Plan-Do-Study-Act (PDSA) cycles to fully implement “bundles” of successful innovations on the postnatal unit at North Carolina Women’s Hospital and evaluate the primary outcome of acute care utilization within 90 days postpartum. The result of this work will be a human-centered redesign of postnatal care to ensure safer transitions for growing families.

The project will enable a stronger start for mothers and their infants and will offer a more integrated, value-based model for care that can be shared with other hospitals for widespread implementation.

Targeted Healthcare Engineering for Systems Interventions in Stroke (THESIS)

Principal Investigator: Shyam Prabhakaran, M.D., M.S., University of Chicago, Chicago, IL
Co-PI: Jane Holl, M.P.H., M.D., University of Chicago Medical Center, Chicago, IL
AHRQ Grant No.: HS027264
Project Period: 09/09/19-09/29/24
Description: The goal of this lab was to reduce diagnostic error and resulting treatment delays in the emergency department (ED) that contribute to missed opportunities to reduce death and disability in acute stroke patients.

Although recommendations and pathways for stroke evaluation and management exist, none of them had been systematically engineered, designed, or tested to identify and effectively address system failures, especially in diagnostic error.

The study aims leveraged three major health systems as a PSLL to:

1. Conduct a multimodal problem analysis to understand latent failures, design constraints, and challenges that result in acute stroke diagnostic error.
2. Intentionally design and develop an Acute Stroke Diagnostic Protocol to reduce acute stroke diagnostic error.
3. Implement the Acute Stroke Diagnostic Protocol in patients presenting to the ED with potential acute stroke and evaluate its effect on diagnostic error and treatment times.

To achieve the lab’s goal, investigators brought together a dynamic team of stroke neurology, emergency medicine, informatics, engineering, and health services experts at three large, diverse healthcare systems in Chicago with experience in the application of systems engineering, problem analysis, design and development, implementation, and evaluation methods. These methods were used to identify and test solutions to reduce diagnostic error and resulting delays in evidence-based treatments for acute stroke patients in the ED.

Towards a Model of Safety and Care for Trauma Room Design

Principal Investigator: Sara Bayramzadeh, Ph.D., Kent State University, Kent, OH
AHRQ Grant No.: HS027261
Project Period: 08/29/19-09/29/24
Description: The goal of this learning lab was to take a comprehensive approach to study the dynamics among people, tasks, technology, organization, and the physical environment in a trauma room, specifically as they relate to workflow, interruptions and disruptions, technology integration, and sensory attributes.

The specific aims were to:

1. Identify factors related to the physical environment that influence patient safety and efficient care in trauma rooms.
2. Develop a time- and cost-effective novel approach to capture observational data in an autonomous and confidential manner to study work system components within trauma rooms.
3. Develop design strategies to address patient safety and efficient care and to integrate technology such that future adaptability is maximized, as new models of patient safety emerge over time.
4. Test proposed design strategies.
5. Develop an evidence-based model, as an end product, for designing trauma rooms that support efficient patient care while maintaining a safe environment.

This study was novel in its approach to data collection and analysis. Through a transdisciplinary collaboration between Kent State University’s Healthcare Design, Nursing, and Computer Science programs and Cleveland Clinic Akron General, investigators used the SEIPS model to investigate obstacles to improved patient safety outcomes in trauma rooms. In the long run, the developed design guide model was expected to contribute to patient safety in trauma rooms by serving as a primary source to direct the design of the next generation of trauma rooms.

R18 Projects Funded in 2022

Applying Human Factors Science, Design Thinking, and Systems Engineering To Mitigate Threats to Neonates Undergoing Resuscitation and Stabilization

Principal Investigator: Louis Halamek, M.D., Stanford University, Stanford, CA
AHRQ Grant No.: R18 HS029123-01
Project Period: 09/30/22–09/29/26
Description: The goal of this learning lab is to improve three specific aspects of neonatal resuscitation: (1) the design of the physical workspace; (2) decision making during this invasive procedure; and (3) human-technology interaction.

The specific aims are to:

1. Assess the range of neonatal resuscitation environments in use and, via simulation and iterative design, explore different room configurations to determine the layouts that facilitate enhanced team performance.
2. Investigate how to display key anatomic and physiologic data, detect data that are trending negatively, and alert staff before a threat manifests.
3. Experiment with methods of minimizing patient handling and reducing the need for manual adjustments of devices that produce imprecise results and interfere with patient care procedures.

Neonatal resuscitation is a time-pressured activity that requires teams to coordinate invasive procedures in a specific sequence of steps. Enhancing the effectiveness and safety of those interventions will have a profound impact on the number of lives saved, the quality of life for survivors, and the annual cost of neonatal intensive care (currently more than $25 billion).

This learning lab brings together experts in clinical neonatology, resuscitation, engineering, human factors, human-centered design, and healthcare simulation. It takes a systems engineering approach to neonatal resuscitation, examining how individual subsystems (e.g., patients, healthcare professionals, physical environments, equipment, supplies, interventions, data, regulations, culture) affect the overall system. Researchers will develop a comprehensive model that identifies multiple potential points of intervention to improve patient care.

The benefits of this work will be generalizable to every facility where pregnant women give birth—rural, inner city, urban, and suburban. This study focuses on neonates, including those born to Black, Latino, Indigenous/Native American, Asian American, Pacific Islander, and LGBTQ+ women. The results of this work will extend beyond the neonatal population. They will apply to improving human and system performance in other complex, safety-critical, time-pressured healthcare domains involving surgical, emergency, and intensive care of pediatric, obstetric, and adult patients.

Center for Immersive Learning and Digital Innovation: A Patient Safety Learning Lab Advancing Patient Safety Through Design, Systems Engineering, and Health Services Research

Principal Investigator: Vinciya Pandian, Ph.D., M.B.A., M.S.N., RN, Pennsylvania State University, University Park, PA
AHRQ Grant No.: R18 HS029124-01
Project Period: 09/30/22–09/29/26
Description: The goal of this learning lab is to use systems engineering methods to identify, design, develop, implement, and evaluate solutions to central line-associated bloodstream infections (CLABSIs), while considering and balancing human and system factors.

The specific aims are to:

1. Foster a new generation of interprofessional clinicians actively engaged in providing safe patient care using virtual simulation and virtual reality to decrease the rate of CLABSIs.
2. Establish the Johns Hopkins Center for Immersive Learning and Digital Innovation (CILDI) as an interdisciplinary, patient/family-informed, and sustainable infrastructure to advance the science of patient safety in preventing and controlling CLABSI using augmented reality approaches.
3. Leverage unique learning lab environment strengths to enhance the translation of systems engineering-based robotic interventions for optimal management of CLABSIs.

COVID-19 has significantly strained U.S. healthcare work systems and exposed the critical need for a redesign of current systems to improve the quality of care and promote patient safety, particularly for inpatient healthcare-associated infections. Crucial to the redesign of those systems is a better understanding of human and system factors in the evaluation of existing care processes and the incorporation of immersive learning technologies and digital innovation to train healthcare workers.

This learning lab will use the Systems Engineering Initiative for Patient Safety (SEIPS) model to advance the science of safety in preventing and controlling CLABSIs. It will engage a digital innovation advisory board, a project team, a systems engineering and human factors advisory core, and a translational advisory core. This project has high potential to improve care processes and patient safety and to decrease CLABSI rates.

Engineering Whole Health Into Hospital Care To Improve Wellness: The M-Wellness Laboratory (M-Well)

Principal Investigator: Sanjay Saint, M.D., M.P.H., University of Michigan, Ann Arbor, MI
AHRQ Grant No.: R18 HS028963-01
Project Period: 09/01/22-06/30/26
Description: The goal of this learning lab is to design, implement, and evaluate innovative, systems-based approaches that can improve patient safety by expanding ways to enhance the wellness of hospitalized patients and their healthcare providers.

The specific aims are to:

1. Enhance patient wellness by designing, implementing, and evaluating a Whole Health inpatient bundle of integrative medical practices. Using the Circle of Health model, researchers will systematically analyze the experience of both patients and physicians through the healthcare system. They will use a tool borrowed from engineering to map a “customer journey” of patients and physicians to better understand time constraints and opportunities to improve their wellness.
2. Address provider burnout and enhance provider wellness through two interlinking projects: 1) conduct a national survey of hospitalists to better understand elements that promote physician wellness, focusing on possible protective factors such as religiosity and spirituality; and 2) design and implement educational interventions to teach hospitalists how best to foster “sacred moments” in the hospital setting.
3. Develop programs to promote interconnectedness between patients and physicians. Researchers will use architectural design, human factors, and the arts to design an optimal hospital room healing environment.

The wellness of patients is inextricably linked to the emotional, mental, and physical health of their providers. Poor provider wellness negatively affects the entire healthcare organization, reducing both care quality and patient satisfaction. Provider burnout is associated with increased risk of patient safety incidents and poorer quality of care due to reduced professionalism. Identifying ways to improve wellness for both patients and their providers thus presents a novel opportunity to improve patient safety.

This learning lab will connect investigators from diverse disciplines, including engineering, medicine, nursing, human factors, architectural design, pastoral care, and business. All of them share a common interest in using healthcare engineering to enhance patient safety. Through these connections, this learning lab will cover the full spectrum of translational research: problem analysis and design; solution development, evaluation, and implementation; and dissemination.

This learning lab will develop and test novel approaches that can save lives, reduce medical costs, and improve patient and family satisfaction with the healthcare they receive, while enhancing the emotional, mental, and physical health of their providers.

Realizing Improved Patient Care through Human-centered Design for Pediatric mental and behavioral health in the Emergency Department (RIPCHD.PED)

Principal Investigator: Anjali Joseph, Ph.D., Clemson University, Clemson, SC
Co-PIs: Meera Narasimhan, M.D., University of South Carolina, Columbia, SC; Ann Dietrich, M.D., University of South Carolina, Columbia, SC
AHRQ Grant No.: R18 HS029109-01
Project Period: 09/30/22–09/29/26
Description: The goal of this learning lab is to develop and implement pediatric mental and behavioral health (MBH) work systems in the emergency department (ED) that promote safe, efficient, and effective care by minimizing unnecessary stressors for patients while improving provider well-being.

The specific aims are to:

1. Use systems engineering methods to develop a shared, indepth understanding of work system facilitators and barriers involved in the pediatric MBH ED caregiving workflow.
2. Design and develop human-centered work systems for pediatric MBH patients in the ED that will improve access to timely MBH care, reduce adverse events, and improve efficiency for ED healthcare providers.
3. Integrate, implement, and evaluate innovative interventions within pediatric MBH work systems in the ED that will improve outcomes for ED patients and healthcare providers.

A multidisciplinary team from Clemson University, Prisma Health, and University of South Carolina School of Medicine will use a systems engineering approach that involves indepth problem analysis, design, development, implementation, and evaluation.

The team will use a range of methods, including workflow analysis, journey mapping, and space syntax analysis, to understand barriers and facilitators and identify opportunities for improvement. They will use an iterative design process to design and develop solutions related to the physical environment, tools and technology, and tasks and workflow.

This learning lab will focus on the needs of children and their caregivers from minority communities to address disparities in MBH care in the ED. Further, the lab will focus on rural and urban EDs to ensure that proposed solutions address a range of resource constraints typically found in EDs across the United States.

Safe and Equitable Telehealth for Chronic Conditions (SafE-T C2) Learning Laboratory

Principal Investigator: Raj Ratwani, Ph.D., M.P.H., MedStar Health Research Institute
Co-PI: Ethan Booker, M.D., FACEP, MedStar Health
AHRQ Grant No.: R18 HS029117-01
Project Period: 09/30/22–09/29/26
Description: The goal of this learning lab is to identify prominent patient safety issues associated with telehealth (synchronous video and phone visits), with a focus on patients with chronic conditions; and design, develop, implement, and evaluate novel safety solutions.

The specific aims are to:

1. Use a multipronged approach to identify telehealth-related patient safety issues.
2. Work with a diverse set of stakeholders, including industry partners, to codesign and develop safety solutions.
3. Implement solutions in outpatient clinics across multiple healthcare systems and use process and outcome measures to determine the effectiveness of the solutions in addressing the intended patient safety issues.

This learning lab will focus on improving the safety, quality, and value of healthcare by addressing chronic conditions, health equity and vulnerable populations, and primary care. The lab is based on a sociotechnical systems engineering framework that considers multiple factors that may contribute to patient safety issues. These include technology, people, processes, and policies.

The research effort is a unique collaboration between MedStar Health, Stanford Health Care, and Intermountain Healthcare. It uses the extensive expertise of the diverse research team, which includes systems engineers, human factors experts, health equity researchers, clinicians, operational leaders, data scientists, clinical application developers, and implementation scientists. It also includes industry partners, a health equity advisory team, a health equity community advisory board, and a patient and family advisory board that will inform all aspects of the project.

Contributions from this learning lab will include identification of prominent safety issues, development and implementation of safety solutions that can be scaled across different healthcare facilities, and new knowledge of which safety solutions are most effective for improving telehealth safety.

R18 Projects Funded in 2023

Digital Innovation, Simulation, and Collaboration using Virtual Environment Realities (DISCOVER) for Pediatric Diagnostic Excellence

Principal Investigator: Maya Dewan, M.D., M.P.H., Cincinnati Children’s Hospital, Medical Center, Cincinnati, OH
Co-PI: Matthew Zackoff, M.D., M.Ed., Cincinnati Children’s Hospital, Cincinnati, OH
AHRQ Grant No.: R18 HS29626-01
Project Period: 9/30/23-7/31/27
Description: The goal of this learning lab is to use systems engineering methodology to envision, develop, prototype, and test design-informed clinical decision support (CDS) approaches to improving diagnosis in an existing and highly immersive virtual pediatric intensive care unit (PICU).

The specific aims are to:

1. Redesign how clinicians interface with CDS tools for diagnosis-intensive events within the PICU environment, including admission and clinical deterioration.
2. Develop and implement design-informed CDS tools for diagnosis and evaluate their appropriateness/acceptability and impact on diagnostic uncertainty, accuracy, and timeliness within a digital twin immersive virtual reality simulation.
3. Establish best practice guidance for implementation of CDS tools in the PICU environment to improve diagnostic excellence.

The learning lab will leverage an existing and highly immersive virtual PICU to assess the effects of implementation strategies on clinician acceptance of CDS tools to improve diagnostic excellence. It will rely on the expertise of LiveWell, a design collaborative with user-centered design and human factors expertise, along with the clinical knowledge, implementation science expertise, and virtual simulation program of Cincinnati Children’s Hospital Medical Center.

The learning lab will evaluate the:

1. Appropriateness, acceptability, and adoption of design-informed CDS tools.
2. Impact on diagnostic accuracy and timeliness in the simulated clinical environment.
3. Proactive implementation plan for the integration of design-informed CDS tools to improve diagnostic excellence into the critical care environment.

Engineering Resilient Community Pharmacies (ENRICH)

Principal Investigator: Michelle Chui, Pharm.D., Ph.D., University of Wisconsin, Madison, WI
Co-PI: James Ford, Ph.D., FACHE, LFHIMSS, University of Wisconsin, Madison, WI
AHRQ Grant No.: R18 HS29608-01
Project Period: 9/30/23-8/31/27
Description: The goal of this learning lab is to reengineer the pharmacy system to advance a combined Safety-I and Safety-II approach to improve chronic care management (CCM).

The specific aims are to:

1. Conduct a problem analysis of the work system through pharmacist and technician observations and interviews, as well as analyses of work system information flow and artifacts, which will illustrate relationships among work system features.
2. Use participatory design and in situ simulations to develop and design Medication Safety Map (MedSafeMap), detailing pharmacy redesign recommendations to optimize pharmacist and technician interactions within their work system and with patients and caregivers.
3. Implement and evaluate MedSafeMap’s impact on Concepts for Applying Resilience Engineering (CARE) and Systems Engineering Initiative for Patient Safety (SEIPS) resilience outcomes. These include pharmacy staff attitudes, behaviors, performance, and work demands (interviews and surveys); time involved in tasks (time and motion analysis); types and quantities of services provided; and perceived changes in medication-related problems (self-reported data).

This innovative, transdisciplinary PSLL will redesign interactions to strengthen pharmacy staff resilience while ultimately improving medication safety for patients needing CCM. It will conceptualize, design, implement, and test MedSafeMap for the community pharmacy setting. MedSafeMap will help pharmacists and pharmacy technicians navigate complex pharmacy tasks and communicate with CCM patients and clinicians. In addition, MedSafeMap will enhance pharmacists’ and technicians’ abilities to either avoid or quickly identify and recover from medication errors before patient safety is endangered.

The learning lab will use the CARE and SEIPS models to define and address the complex pharmacy work system issues that increase medication safety risks for patients who need CCM. Its transdisciplinary team of pharmacists, health services researchers, engineers, and quantitative and qualitative researchers will partner with pharmacies to design and evaluate MedSafeMap. The team will work with two large healthcare organizations (Advocate Health and UW Health), along with Boscobel and Center independent pharmacies.

Patient-Driven Medication Safety Learning Laboratory in Care Transitions

Principal Investigator: Ranjit Singh, M.B., B.Chir., M.B.A., University at Buffalo, State University of New York, Buffalo, NY
Co-PIs: Heui-Yen Chen, Ph.D., University at Buffalo, State University of New York, Buffalo, NY; David Jacobs, Pharm.D., Ph.D., University at Buffalo, State University of New York, Buffalo, NY
AHRQ Grant No.: R18 HS29122-01A1
Project Period: 9/1/23-6/30/27
Description: The goal of this learning lab is to bring together older adults, caregivers, researchers, and healthcare teams in innovative ways to protect them from medication harm.

The specific aims are to:

1. Use a multifaceted approach to identify and understand the causes and outcomes of medication problems in transitions of care, including the needs and priorities of patients and caregivers, and the operational complexities that shape and constrain care transition work. Researchers will study patients’ and caregivers’ experiences with recent hospitalizations, focusing on medication changes, associated symptoms, and social determinants of health (SDOH)-related challenges. They also will perform cognitive engineering analysis to identify cognitive work challenges and their associated information needs involved in the care transition work at hospital and primary care sites. In addition, they will use health information exchange data to identify patient- and system-level risk factors and develop risk algorithms for unplanned hospitalizations and medication harm.
2. Iteratively design and develop patient-driven interventions with input from key stakeholders (e.g., members of the project’s Community Advisory Board).
3. Implement and evaluate promising solutions, first in a simulated environment (with realistic tasks) and subsequently in a clinical setting.

The learning lab will empower patients and caregivers in partnership with the healthcare system team, starting with analyzing the existing medication safety work system, spanning the entire transition of care. This analysis will lead to the design, development, and testing of scalable, human-centered interventions in a simulated environment with input from practicing clinicians and patients as the end users, followed by pilot testing in the clinical environment.

The learning lab’s approach puts the focus on patients and caregivers, with attention to SDOH, and engages them extensively in every step of the systems engineering process. The interventions created through this research, from the patient perspective, will further address health equity and will make all communities, regardless of location, healthier. The learning lab’s infrastructure and pilot data will create a strong foundation for a sustained stakeholder partnership that will spawn future funded studies to improve medication safety for older adults.

Pediatric Transport Learning Laboratory

Principal Investigator: Rachel Umoren, M.B.B.Ch., M.S., University of Washington, Seattle, WA
AHRQ Grant No.: R18 HS29607-01
Project Period: 9/1/23-6/30/27
Description: The goal of this learning lab is to advance the care of pediatric patients (up to 21 years of age) during medical ground or air transport from one hospital to another within a regional network.

The specific aims are to:

1. Collaborate with transport providers and other involved parties to analyze current workflow processes, transport records (local and statewide databases), and infrastructure at referral and receiving facilities to fully understand system issues and define the current and ideal states.
2. Integrate real-time data into a transport digital twin model to optimize regional consultation, triage, and transport of pediatric patients to facilities with the appropriate level of care and availability of space and staffing.
3. Use input from clinical transport team staff and stakeholders to integrate machine learning into the Transport Monitoring and Communications (T-MAC) system. This effort will support the analysis of data feeds while on transport. Researchers will conduct repeated testing and revision of the machine learning-augmented T-MAC system to ensure that it can functionally and efficiently facilitate information flow between the medical control physician, referring facility, and transport team. They will also work with families to identify gaps in communication and connection to local and receiving facility resources and identify transport-specific needs. In addition, they will develop robust processes to support information flow to patients and families in the peritransport period.
4. Evaluate the efficacy of the T-MAC system in a realistic in situ simulation and in clinical settings.

The learning lab will build on researchers’ previous experience with neonatal patient transport to identify and address the salient issues and risks of regional neonatal transport for which new and innovative approaches are needed. The lessons learned will improve pediatric patient safety on medical transports and will be transferable to patient populations that undergo both short- and long-range interfacility transports.

The learning lab will work with collaborators from the University of Washington Industrial and Systems Engineering Department. The lab will bring together pediatricians, pediatric specialists, transport teams, parent representatives, design specialists, and engineers. It will use quality improvement methodologies for clinical workflow process evaluation, as well as Lean UX and agile methodologies for design and development.

Perinatal Mood and Anxiety Disorder (PMAD) Learning Laboratory in a Freestanding Children’s Hospital

Principal Investigator: Lamia Soghier, M.D., F.A.A.P., C.H.S.E., Children’s National Medical Center, Washington, DC
Co-PI: Niyousha Hosseinichimeh, Ph.D., M.P.A., Virginia Tech, Washington, DC
AHRQ Grant No.: R18 HS29458
Project Period: 9/30/23-7/31/27
Description: The goal of this learning lab is to provide safe, comprehensive, point-of-care access to mental health services for parents of infants treated in children’s hospitals.

The specific aims are to:

1. Optimize screening, referral, and treatment for postpartum depression in the neonatal intensive care unit (NICU) and pediatric emergency department (PED) using system dynamics techniques for group model building. Researchers will analyze the current workflow, identify barriers, elicit system requirements from involved parties, map the system, and develop a system dynamics simulation model to test solutions in a virtual environment.
2. Design a novel software dashboard for real-time tracking of eligible mothers with its accompanying parent-facing app and develop a predictive model to identify at-risk mothers. Researchers will then develop a measurement system to monitor key performance indicators.
3. Implement new solutions, monitor, and evaluate the system for unintended consequences before and after implementation. Researchers will perform a difference-in-difference estimate and a cost-benefit analysis to evaluate the changes.

The learning lab will use novel approaches and new technology to assist in the recognition and treatment of PMAD on a large scale in the NICU and PED of a freestanding children’s hospital. It will use benchmarking and systems monitoring and will evaluate system threats and costs. The results will be generalizable to the treatment of other mental health disorders that affect postpartum parents and will contribute to improvement in short- and long-term health outcomes of parents and infants at higher risk than the general maternal population.

Resilient Communication Systems: A Pediatric Patient Safety Learning Lab (RECALL)

Principal Investigator: Halley Ruppel, Ph.D., R.N., University of Pennsylvania, Philadelphia, PA
AHRQ Grant No.: R18 HS29473-01
Project Period: 8/1/23-5/31/27
Description: The goal of this learning lab is to reengineer interprofessional (e.g., nurse-physician) communication work systems for pediatric acute care settings.

The specific aims are to:

1. Conduct a problem analysis of the interprofessional communication work system and work processes used in the care of hospitalized children.
2. Design and develop interventions to engineer a safer, more effective, and more resilient interprofessional communication work system.
3. Implement and evaluate the interventions in the clinical environment to gauge real-world impact.

The learning lab will proactively assess interprofessional communication work systems, processes, and outcomes to identify opportunities for improvement before safety events occur. It will develop a resilient interprofessional communication system that can positively adapt in the face of anticipated and unanticipated changes and maintain the safety of care provided during pediatric hospitalizations. The results will be relevant to all hospitalized children, since communication between clinical teams is essential for safe, effective, and high-quality care.

The learning lab’s multidisciplinary team includes clinician-researchers, human factors engineers, human-centered design experts, and operational safety experts from Children’s Hospital of Philadelphia and the University of Pennsylvania. The learning lab will also engage involved parties, including bedside clinicians and families of hospitalized children, whose experience of care may be altered by changes to how clinicians communicate. It will be guided by two frameworks: the Systems Engineering Initiative for Patient Safety model and the Integrated Resilience Attributes Framework.

Resilient EMS PSLL: Using a Systems Engineering Approach To Enhance EMS Cognitive Work and Safety for Older Adults During Prehospital Care

Principal Investigator: Ayse Gurses, Ph.D., M.S., Johns Hopkins University, Baltimore, MD
AHRQ Grant No.: R18 HS29629-0
Project Period: 9/30/23-7/31/27
Description: The goal of this learning lab is to enhance and support safety, quality, and equity within prehospital emergency care of older (≥ 65 years) adults.

The specific aims are to:

1. Identify and define individual and distributed cognitive work system characteristics that impact safety, quality, and equity along the continuum of prehospital resuscitative care (dispatch call transition of care). The lab will focus on older adults presenting with a potentially critical chief medical complaint (e.g., respiratory distress, acute onset of altered mental status) not related to trauma.
2. Work with key stakeholders  to support the cognitive work of emergency medical services (EMS) professionals needed for dynamic resilient performance. The team will use human-centered and inclusive design principles and methodologies. Stakeholders include EMS professionals, patients (older adults), caregivers, and other professionals.
3. Implement and evaluate proposed design and redesign solutions using a multiprong approach for improving safety, quality, and equity along the continuum of resuscitative care for older adults through support and enhancement of EMS professionals’ individual and distributed cognitive team-based work.

The learning lab will use systems and human factors engineering approaches to innovate in support of EMS professionals’ real-time cognitive work as individuals (e.g., making decisions) and as team members (e.g., sharing mental models). It will conduct a 4- year, multisite, multimethod field study of geriatric prehospital emergency care in rural, suburban, and urban EMS prehospital care environments.

The learning lab includes experts in patient safety, human factors, systems engineering, communication, prehospital care, emergency medicine, geriatrics, nursing, health disparities, and patient and family partners. The results will lead to new insights into prehospital care that will aid in creation of innovative, inclusive, and human-centered solutions.

Re-engineering Surgical Recovery and Transitions Using Technology Patient Safety Learning Laboratory (REST-PSLL)

Principal Investigator: Genevieve Melton-Meaux, M.D., Ph.D., University of Minnesota, Minneapolis, MN
Co-PIs: Jenna Marquard, Ph.D., University of Minnesota, Minneapolis, MN; Elizabeth Wick, M.D., University of California, San Francisco, CA
AHRQ Grant No.: R18 HS29616-01
Project Period: 9/1/23-6/30/27
Description: The goal of this learning lab is to apply systems engineering approaches to coproduce innovative and scalable patient- and care team-centric solutions for emergency laparotomy (EL) home-based recovery.

The specific aims are to:

1. Identify barriers and facilitators to ideal at-home recovery for patients following EL. Researchers will engage stakeholders using the Systems Engineering for Patient Safety model to identify and evaluate barriers and facilitators of optimal care and postoperative complications, with a focus on surgical site infections.
2. Iteratively design and develop new processes, tools, and technologies that help remove or reduce barriers to ideal at-home recovery. Researchers will use swimlane diagrams to analyze for areas of improvement. They will then generate initial design requirements and prototypes for tools and technologies, followed by iterative user-centered design to specify design requirements, develop solutions, and conduct end-user testing at clinical sites.
3. Implement and evaluate solutions in practice. Researchers will perform pilot testing and implementation and will assess primary outcomes (addressing or avoiding trigger/potential issue, solution use) and secondary outcomes. They will be guided by the Reach Effectiveness Adoption Implementation Maintenance framework. Researchers will evaluate implementation phases guided by the Exploration Preparation Implementation Sustainment framework to generate implementation learnings and plans for revising solutions.

The learning lab will engage diverse stakeholders to coproduce technology solutions for EL home- and transition-based workflows to empower EL patients, their caregivers, and their care teams to achieve optimal outcomes and safe recovery. It will draw from transdisciplinary complementary systems expertise and approaches and deep clinical expertise to expand or optimize existing solutions and platforms. The results will be relevant to other surgical populations.

Retained Foreign Object Reduction and Mitigation (ReFORM)

Principal Investigator: Ken Catchpole, Ph.D., Medical University of South Carolina, Charleston, SC
AHRQ Grant No.: R18 HS29637-01
Project Period: 9/30/23-8/31/27
Description: The goal of this learning lab is to explore the causes of and solutions to retained foreign objects (RFOs) using a systems engineering approach.

The specific aims are to:

1. Use initial systems models to drive improved understanding of factors that influence successful and unsuccessful counting of items that enter and leave the surgical field.
2. Use laboratory experiments in count grouping—including time pressures, distractors, and role of technology—to define and build an evidence base for optimal counting strategies.
3. Identify opportunities to enhance the counting process before the surgery starts and to improve the discovery of lost items in the case of a discrepant count.
4. Explore opportunities to enhance teamwork and organizational learning processes after RFO events.

SafeCare@Home4Kids Learning Lab: Designing Safer Healthcare at Home for Children

Principal Investigator: Carolyn Foster, M.D., M.S.H.S., Lurie Children’s Hospital of Chicago, Chicago, IL
Co-PI: Nicole Werner, Ph.D., M.S., Indiana University, Bloomington, IN
AHRQ Grant No.: R18 HS29638-01
Project Period: 9/30/23-7/31/27
Description: The goal of this learning lab is to identify, communicate, and prevent safety errors and adverse events that occur in the home by diverse parents and home healthcare (HHC) providers. The methods used should ensure that children are safe, notify the children’s care providers, prevent recurrence, and be equitable to all patients and families.

The specific aims are to:

1. Construct the SafeCare@Home4Kids multidisciplinary lab of experts to design innovative, effective, and equitable approaches to preventing healthcare safety errors and adverse events experienced by diverse children with medical complexity (CMC) at home. Experts will be in the areas of patient safety, human factors engineering, nursing, pediatrics, HHC, informatics, and lived family experience.
2. Determine how family caregivers and home nurses currently identify, communicate, and prevent medication and device-related errors and adverse events in the context of the home-work system.
3. Codesign, implement, and evaluate a safety toolkit that addresses these elements of medication and device safety using input from families, home nurses, prescribing providers, and other experts to improve patient safety at home.

The learning lab represents an innovative paradigm shift in safety research by focusing on the home as a fundamental healthcare practice setting for CMC. It addresses common reasons CMC use the emergency department or are hospitalized. It will draw on national interdisciplinary experts, partner with patient/family leaders, and recruit a linguistically and racially diverse participant population.

Shock Patients: Interprofessional Communication to Enhance Diagnosis (SPICED)

Principal Investigator: Anne Stey, M.D., M.Sc., Northwestern University, Chicago, IL
Co-PIs: Andrew Berry, Ph.D., M.S., Northwestern University, Chicago, IL
AHRQ Grant No.: R18 HS29483-01
Project Period: 8/1/23-7/31/27
Description: The goal of this learning lab is to improve the safety of critical care medicine by addressing poor interprofessional communication.

The specific aims are to:

1. Understand why interprofessional clinicians disagree on the cause of shock.
2. Design a systematic process for interprofessional clinicians to share information and their assessments and to build a shared understanding of the cause of shock.
3. Put into clinical practice and measure how this systematic process improves agreement among clinicians, as well as the timeliness and accuracy of the identification of the cause of shock.

The learning lab will identify modifiable healthcare system factors that lead to disagreement among clinicians about the cause of shock. It will then design and test a systematic process to identify the cause of shock, determine how to treat it, and reduce the high risk of death. The learning lab will use a variety of methods, including machine learning, critical incident technique, user-centered design, implementation science, and interrupted time series analysis.

TRANS-SAFE Patient Safety Learning Lab: Systems Improvement for Psychosocial Safety in Transgender Care

Principal Investigator: Jennifer Anger, M.D., M.P.H., University of California, San Diego, CA
Co-PIs: Alan Card, Ph.D., M.P.H., University of California, San Diego, CA; Tara Cohen, Ph.D., Cedars-Sinai, Los Angeles, CA
AHRQ Grant No.: R18 HS29299-01
Project Period: 4/10/23-1/31/27
Description: The goal of this learning lab is to identify and address the systemic causes of psychosocial harm in transgender people.

The specific aims are to:

1. Identify the contributing factors leading to avoidable patient suffering in transgender individuals. Researchers will apply human factors, improvement science, risk management, and biopsychosociotechnical systems approaches to conduct a human-centered problem analysis that identifies determinants of avoidable patient suffering in transgender individuals, including issues such as misgendering, disrespect, and abuse, as well as “getting lost in the system.”
2. Codesign human-centered solutions to prevent and mitigate avoidable patient suffering in transgender individuals. Researchers will engage with the full range of interested parties in an iterative process of codesign and development. They will use both new and proven tools to produce interventions that address the systemic determinants of psychosocial harm in transgender individuals.
3. Evaluate the effectiveness of proposed interventions in real and simulated clinical environments. Researchers will test the interventions designed in aim 2 in both actual practice settings and in simulation to evaluate effectiveness, acceptability, usability, implementability, and sustainability.

The learning lab will leverage an interdisciplinary team of clinical and systems improvement experts. It will use an innovative dissemination approach (a certification program in partnership with the World Professional Association for Transgender Health) to facilitate widespread and sustainable impact.

Contact Information

AHRQ Project Officer Email Addresses

• Burgess, Denise (AHRQ/CQuIPS): Denise.Burgess@ahrq.hhs.gov
• Chew, Emily (AHRQ/CQuIPS): Emily.Chew@ahrq.hhs.gov 
• Cosby, Karen (AHRQ/CQuIPS): Karen.Cosby@ahrq.hhs.gov
• Deutsch, Ellen (AHRQ/CQuIPS): Ellen.Deutsch@ahrq.hhs.gov
• Gray, Darryl (AHRQ/CQuIPS): Darryl.Gray@ahrq.hhs.gov
• Gripiotis, Erofile (AHRQ/CQuIPS): Erofile.Gripiotis@ahrq.hhs.gov
• Haugstetter, Monika (AHRQ/CQuIPS): Monika.Haugstetter@ahrq.hhs.gov 
• Rodrick, David (AHRQ/CQuIPS): David.Rodrick@ahrq.hhs.gov
• Raab, Stephen (AHRQ/CQuIPS): Stephen.Raab@ahrq.hhs.gov
• Rashford, Venice (AHRQ/CQuIPS): Venice.Rashford@ahrq.hhs.gov
• Rodrick, David (AHRQ/CQuIPS): David.Rodrick@ahrq.hhs.gov
• Samad, Farzana (AHRQ/CQuIPS): Farzana.Samad@ahrq.hhs.gov
• Shofer, Margie (AHRQ/CQuIPS): Margie.Shofer@ahrq.hhs.gov

For more specific information on AHRQ's research priorities and funding opportunities, please visit Funding and Grants.

For specific programmatic questions about Patient Safety Learning Laboratories and other patient safety topics, please contact:

David Rodrick, Ph.D.
Agency for Healthcare Research and Quality
5600 Fishers Lane
Rockville, MD 20857
Phone: 301-427-1876
Email: David.Rodrick@ahrq.hhs.gov