Guide to Improving Patient Safety in Primary Care Settings by Engaging Patients and Families

Reduced patient safety in primary care is influenced by patient-related, provider-related, and health system or practice-related factors. (Policy-related factors have also been identified but are beyond the scope of this project.) Factors influencing patient safety within primary care seldom occur in isolation but are part of a complex matrix within the health care environment.³⁶

In this environmental scan, four key threats to patient safety in primary care emerged. These were validated through our key informant interviews and by our Technical Expert Panel. The four threats are:

• Communication breakdowns (among patient, provider, and practice staff).
• Medication management (reconciliation, prescribing, adherence, overuse).
• Diagnosis and treatment (decisionmaking, information transfer, missed diagnosis, delayed diagnosis).
• Fragmentation and environment of care (identification issues, transfers, care coordination, safety culture, reporting, and error management).

These findings have been confirmed in recent systematic reviews and technology assessment reports on patient safety in ambulatory care.^37–41

Of these, factors related to communication breakdowns and fragmentation of the care process were the highest sources of safety issues identified in the peer-reviewed and grey literature. These were followed by issues surrounding medication prescribing, management, and adherence and diagnostic error. Our environmental scan revealed that each of these threats to patient safety is multifaceted, with no single solution rising to the top as the catalyst for improvement. Barriers to improving patient safety are reported at the patient, provider, and practice staff levels.

We have organized the findings of our environmental scan along the four threats to patient safety in primary care settings. We examine strategies identified to close the gaps in safety and those specifically linking enhanced patient and family engagement to improved patient safety in primary care. Appendix F includes a full list of interventions and resources identified during the environmental scan.

Patient Safety Issues in Primary Care

Communication

The issue of communication slips and lapses leading to medical error, near-misses, and unsafe conditions in primary care was the most widely reported problem. It underlies other issues related to medication management, diagnosis and treatment, and organizational structure and safety (e.g., fragmentation of care).^42–49 Communication errors between the patient and the care provider, the patient and practice staff, and providers and practice staff have all contributed to medical error in primary care.

Extending beyond the local practice setting, errors related to communication breakdowns between the primary care practice and other health care settings (e.g., hospital, home care, emergency departments, community pharmacy) have also been reported as contributing to the patient safety landscape of primary care.^{39,43,46,50–56} Errors within this domain may include errors in referral and errors in communicating test results.

Given its ubiquitous relationship to patient safety in primary care environments, strategies to improve communication are at the forefront of patient safety efforts. The target audiences for the interventions have primarily been patients and physicians.

Education is the most common approach to encouraging adoption. Patient education focuses on providing detailed brochures on how to be a safe patient,^57–61 guidance on being prepared for an appointment,⁴ and guidance on asking questions^60–66 and generating lists of medications^67–70 to support shared decisionmaking and open communication with the care team. Provider education has focused on training in motivational interviewing, coaching, and other supportive approaches to engage in shared decisionmaking^{6,7,58,60,71–73} with patients.

Recently, communication approaches more commonly associated with acute health care settings and high reliability have emerged in the peer-reviewed and grey literature for ambulatory care settings, including primary care. Examples include elements of the TeamSTEPPS^® approach, including SBAR (situation, background, assessment, recommendations);^74–77 daily huddles;^78–80 and other approaches to team-based care.^42,81–85

Another key emerging trend is using the electronic medical record as a tool for communicating with patients and communicating through patient portals (e.g., Open Notes).^60,86–90 For physicians managing patients with chronic disease, supportive tools and technologies to guide discussions with patients around therapeutic options and treatment decisions continue to evolve in complexity and usability (e.g., option grids, decision aids).^60,91–93 A recent systematic review on the use of text messaging in primary care resulted in increased adherence to medications, demonstrating strong evidence for its use as an adjunct to traditional communication strategies to improve care.⁶⁰ Additional educational strategies around literacy, health literacy, and cultural and contextual competency were also reported.^{60,81,94–96}

Our environmental scan findings detail a complex web of communication within the primary care environment. Engagement of patients and families in overcoming communication breakdowns has the potential for broad-reaching improvements in patient safety in primary care. The peer-reviewed and grey literature is replete with strategies to enhance communication between patients and providers around therapeutic options, medications, and chronic disease management.

Many of the strategies were confirmed through consultation with our key informants and members of the Technical Expert Panel. Efforts to improve patient awareness of existing strategies to improve communication are warranted. In addition, increasing usability of the interventions is needed to enhance adoption into routine practice. Encouraging communication between patients, providers, and practice staff is central to improving patient safety in primary care. Improved communication has the potential to affect all identified patient safety issues that surfaced during our environmental scan. Thus, strategies to enhance patient-provider partnerships in communication should be considered a key element of the Guide.

Medication Issues

One of the most widely studied sources of medical error in both acute and nonacute health care settings is medication errors.^{39,70,97–101} Errors occur at the prescribing, filling, and administration stages of medication management. Prescribing errors included prescribing the wrong medication, prescribing medications with drug-drug interactions, and making errors related to transcription of written prescription orders.

Filling and administration errors include patients not filling their prescription, patients not understanding why they are on a new or different medication, and patients not taking the medications as prescribed. Each of these gaps in medication safety has yielded different approaches to reduce opportunity for error. Efforts to reduce medication errors in the ambulatory care setting, including primary care, have focused on:

• Medication reconciliation,^102–105
• Patient medication lists,^{67,69,70,106–109}
• Pharmacist-led interventions,^60,110–114
• E-prescribing, and
• Computerized physician order entry.^115,116

Education and training has accompanied most interventions, except for those directed toward patients specifically.

Two recent systematic reviews of safe medication use in primary care acknowledged that much of the research aimed at reducing medication errors has focused on single interventions. The authors contend that co-implementation of interventions may provide the most effective options to improve medication safety in primary care.^98,117

Our environmental scan yielded several important findings about strategies to improve medication safety in primary care. Medication lists were the primary strategy aimed at patients, family members, and caregivers. Our team identified no fewer than 40 medication lists, pill cards, and smart phone applications available to patients to keep track of their medications (for a complete list, see Appendix F).^{18,58,102,114,118–120}

Despite a field with numerous interventions to improve medication adherence and medication safety by engaging patients through medication lists, few of these strategies have seen widespread adoption. More recently, patient-facing strategies such as sharing medical notes¹²¹ and providing automatic refill reminders¹²² have been associated with higher levels of medication adherence among patients.

Strategies aimed at the provider and practice levels were also reported, although with much less frequency. Interventions such as innovative approaches to medication reconciliation, e-prescribing,^60,114 and integration of community pharmacists into the extended care team^{110,111,113,123,124} all appeared to improve medication safety in primary care. Emerging strategies such as group visits and engaging the extended health care team to provide coaching and conduct teach-back around new medications were described in the literature and validated by our key informants.^125–127

Results of the environmental scan suggest that errors in medication management within primary care represent a significant threat to patient safety. Engagement of patients in improving safety through adherence and education are the core strategies currently used. Patient-directed interventions rely highly on patients already being activated in their care to seek and use the wide variety of tools and techniques available for maintaining medication records.

Most of these interventions are geared toward individuals taking more than one medication and those with complex chronic conditions.^128–130 However, limited evidence is available on whether these patient populations were included in the development of the approaches. At the same time, the role of primary care providers and practice staff is expanding in supporting medication management in their patients. Strategies for practices to support and engage patients in medication adherence and management should be considered in developing the Guide.

Diagnostic Error

Estimates of diagnostic error in outpatient care suggest that approximately 1 in 20 adult patients in the United States is affected, resulting in significant costs to patients, families, providers, and the health system.^131–133 Diagnostic error has been operationally defined as "diagnoses that are unintentionally delayed (sufficient information to make a diagnosis was available earlier), wrong (another diagnosis was made before the correct one), or missed (no diagnosis was made)."¹³⁴ A recent study found that of the closed claims occurring in primary care over a 5-year period, 72.1% were related to alleged diagnostic error.¹³⁵

Despite its estimated prevalence, evidence on the epidemiology and potential interventions to reduce diagnostic error in primary care are only now emerging.^{50,131,136–140} Some of this challenge is due to how primary care is delivered.^134,141 Diagnostic error in primary care is a complex process with implications for patients and providers, as well as practices and health systems.

Ultimately, diagnostic error relates to the principle of uncertainty inherent in the diagnostic process.^{131,139,142,143} Most diagnostic errors in primary care are related to process breakdowns in the patient-practitioner clinical encounter.³⁸ Thus, efforts to improve the patient-provider interaction, specifically those that involve data gathering (e.g., pre-labs, testing followup), have the greatest potential for influencing patient safety in primary care.

Recent systematic reviews and consensus reports identified patient safety strategies targeting diagnostic errors.^{37,39,50,133,134,139,142–144} Emerging evidence suggests that solutions focusing on patient, physician, and practice-related factors can have the greatest impact on reducing diagnostic error.^{39,134,142,144} One recent study found that to prevent diagnostic errors and improve patient safety, interventions needed to be context specific and targeted to:

• The needs of the patient population being served (i.e., socioeconomic and demographic characteristics),
• The environment of the clinical care site (urban, rural, or suburban), and
• The practice setting (acute, ambulatory care, primary care, or home care).

Each of these factors needs to be considered when designing interventions and approaches to overcoming diagnostic error.

Opportunities to integrate patients, families, and caregivers into the process of preventing diagnostic error may occur at several levels within the primary care environment. These include more actively engaging patients in the diagnostic process and monitoring of outcomes, engaging patient and family stakeholders in the health system environment, and engaging patients and advocates in research and policy development.^141,145,146

For primary care settings, strategies to more actively engage patients and families in the diagnostic process could include:

• Shared decisionmaking,^{73,92,147,148}
• Enhanced previsit planning, including pre-labs,^87,149,150
• Structured patient-provider communication, including asking questions,^47,151,152
• Sharing of provider notes,^86,88–90
• Use of mobile, text, and secure electronic mail messaging to enhance adherence to the therapeutic plan and monitor health status,^153–155 and
• Use of patient portals,^60,124,156 among others.^{58,136,137,144,157}

Providers and the practice environment need to be supportive of patient engagement in these activities, overcoming fears, powerlessness, and vulnerability inherently related to illness.¹⁵⁸ Enabling behaviors include avoiding dismissive or disrespectful behavior, encouraging patients to ask questions and listening to their responses, setting expectations for followup of diagnostic tests, and making efforts to streamline often uncoordinated care.^56,67,141

These findings are consistent with the recommendations of our Technical Expert Panel members and key informants, as well as the more than 130 articles, resources, tools, and reports that have identified strategies aimed at improving the diagnostic process. Resources to support patients in more actively engaging in their care continue to surface.

Our work suggests that active engagement of patients and families throughout the diagnostic process may yield important improvements in the safety and quality of health care. Several promising interventions and intervention bundles to support engagement in the diagnostic process emerged during our environmental scan and should be considered for Guide development. The feasibility of integrating these interventions into the standard of practice in primary care will require a comprehensive approach to behavior change for physicians, patients, family members, and practice organizations.

Fragmentation

Fragmentation has been defined as the "lack of standardization and innovation, dissemination, trust, and a safety culture," and is seen as a threat to safety in health care systems.⁴³ In our environmental scan, we have operationally defined fragmentation as breakdowns in the transition of patients between providers (or health care settings) with a resulting loss of critical information and valuable time on behalf of the provider and the patient.

Like communication breakdowns, fragmentation can have far-reaching outcomes. Approaches to overcoming the impact of fragmentation in primary care practices have yielded two primary foci: improving the standardization of care delivery and providing relationship-based care.

In the words of one of our Technical Expert Panel members, standardization from the patient's perspective simply means "every patient, every time." Adopting team-based approaches to care encourages standardization of practice workflow and efficiencies.^{77,80,101,159} Recent evidence suggests that standardizing structured communication and patient experiences in primary care through the adoption of checklists may be one way to improve safety.^43,159 Continuity of relationships in primary care, in which a patient has one primary care provider who manages his or her care over a long period of time, is another approach suggested to improve decisionmaking and engagement in primary care.^82,160,161

Patients also have a role in reducing the impact of fragmentation. Our key informants indicated that setting expectations for the patient for the completion of diagnostic tests and setting timelines for followup either via phone or in person are important steps patients can take immediately to improve care. Engaging and empowering patients through partnership was identified as a crucial step to increase patient safety.^162–164

Our findings indicate that increased engagement from patients and families could help address fragmentation issues. Promising interventions for improving the standardization of care delivery and providing relationship-based care, to reduce the impact of fragmentation, should be considered for the Guide.

Strategies To Engage Patients and Families and Improve Safety

The environmental scan revealed that while the field of patient safety in primary care is new, several important innovations aimed at improving patient safety in primary care have emerged.^{43,48,83,141,161,165} Interventions exist that focus on providers, patients, and practices as the target audience, with varying strength of evidence of effectiveness, impact, and demonstrated usability.

Table 10 outlines the common themes of interventions and approaches that have demonstrated success or have received strong recommendations from our key informants for consideration for inclusion in the Guide. The interventions are organized by target audience.

Table 10. Recommended Interventions

Below, we review specific interventions that cut across multiple domains of safety issues in primary care, briefly describe factors affecting their usability, and discuss their effectiveness.

Shared Decisionmaking

Our environmental scan yielded strong evidence from peer-reviewed and grey literature and from patients, family members, and primary care providers on the importance of shared decisionmaking to improving patient safety in primary care.^{4,36,41,58,60,71–73,84,91–93,114,123,124,130,141,145,147,148,163,166–215} Shared decisionmaking has established effectiveness for improving decisionmaking around medications, alternative treatments, chronic disease management, and self-management strategies. Toolkits and resources such as the SHARE Approach from the Agency for Healthcare Research and Quality, decision aids, and option grids support the patient-provider partnership in care decisions.^91,147,178

Factors influencing the impact of shared decisionmaking from the provider perspective include quality of the patient-provider relationship, importance of quick patient recovery, and physician knowledge of treatment options. Concurrently, patient’s influencing factors include ensuring a correct diagnosis from the provider; getting information on treatment options, including perceived harms and benefits; and getting a clear explanation of the care trajectory.²¹⁶

The field of shared decisionmaking continues to evolve and approaches to enhance patient-provider partnership in primary and specialty care continues to grow. We found several study protocols describing new approaches to supporting shared decisionmaking. For example:

• An intervention aimed to improve shared decisionmaking between patients and providers to enhance diabetes management among Mexican Americans.²¹⁷
• Another protocol aimed to improve medication adherence in older adults.¹³⁰
• One intervention that promotes shared decisionmaking between family physicians and their patients led to a reduction in antibiotic overprescribing and had no effect on patient satisfaction.^{60,114,147,148,178,218}

Although shared decisionmaking interventions can be beneficial, there is heterogeneity in their application and further data are needed to show they can improve health outcomes.⁶⁰

Despite the encouraging evidence of the impact shared decisionmaking could have on patients, several barriers to adoption were also reported. The primary barrier to shared decisionmaking is the limited time providers have for deep and meaningful conversations with patients.^48,149,219 The provider’s time pressures and the patient’s needs in the relationship are factors that need to be considered when evaluating the inclusion of shared decisionmaking as an intervention in the Guide.

Patient and Family Advisory Councils, Boards, and Committees

Patient and family advisory councils, boards, and committees were identified through the grey literature search and in consultation with our Technical Expert Panel and key informants as an important strategy for improving patient safety.^{2,6,7,10,41,58,65,85,161,181,184,196,197,204,205,220–228} Strategies for engaging patients as advisors in the acute care setting are quite mature, and several toolkits are available. Patients as advisors in the hospital setting have emerged through our environmental scan, including several supported by the Agency for Healthcare Research and Quality.^8,229 A recent addition to the field has come from the Institute for Patient- and Family-Centered Care and is specific to advisory committees in the ambulatory care setting.

Few published reports exist on the impact of patient advisory councils on patient safety that include tests of change. One published report indicated that an advisory committee-led intervention resulted in a significant improvement in the number of accurate medication lists for patients in ambulatory care practices in Wisconsin.^226,227 Here, the number of patients with accurate medication lists improved from 55 percent of patients to 72 percent of patients.

Another narrative report of the impact of a patient advisory council on family medicine practices transitioning toward patient-centered medical homes indicated that the advisory council had "changed the conversation." Improvement efforts of this council have focused on improving communication and access, redesigning the practice and signage, helping redesign the patient portal, and holding the practice accountable for quality and experience data.¹⁸⁴

Interviews with practices and leaders in patient engagement from across the country indicate that the approach to engaging patients and families as advisors in primary care is similar to the approach used in the acute care setting. Models in primary care exist, developed as part of statewide practice improvement collaboratives or by patients in a grassroots approach to improving care.

Evidence of impact is suggestive, primarily consisting of case studies and individual reports. But when it is designed to focus on quality and safety of care, a patient advisory council may be an effective approach to engaging the community to overcome practice challenges.

Team-Based Care

Team-based models of care can help reduce medical errors related to communication breakdowns, diagnostic errors, and medication management issues and are a key driver of increasing standardization (thus reducing fragmentation) within primary care settings.^{4,7,43,53,54,56,58,82,101,118,123,136,141,164,179,195,200,203,205,230–239} Strategies to improve team-based care within primary care settings include:

• Team documentation,
• Daily team huddles,
• Expanded care teams,
• Care navigators/case managers, and
• Inclusion of the patient and family members as part of the team.

Strategies such as the patient-centered medical home and patient-centered care coordination have yielded important improvements in team culture of safety and willingness to speak up and have also been associated with improved patient and professional satisfaction. While still emerging, strategies for enhancing teamwork can significantly affect all domains of safety lapses in primary care environments. Challenges to implementation include organizational readiness, payment structure (fee for service versus bundled payments), infrastructure, staff and physician readiness, and patient acceptance of the team approach.

Interventions To Support Medication Safety

Approaches to improve medication safety in primary care include:

• Patient-focused applications for medication lists,
• Team documentation,
• Efforts to partner with patients on medication reconciliation activities,
• Access to medication history through an electronic patient portal, and
• Other technology-mediated processes to support medication adherence.^{7,39,41,43,45,52,53,58,60,70,82,85,90,98,101,104,110–112,114,115,117,118,120,126,129,135,164,169,179,202, 204,224,232,237,238,240–256}

More than half of the medication-related interventions identified in our environmental scan included approaches to ensure accurate medication lists for patients. Evidence of effectiveness of the medication lists was limited, and they were of questionable usability. Smart phone applications aimed at maintaining records of medications and providing medication reminders have emerged over the past several years. Patient reviews of these applications were scarce.

Medication reconciliation remains an important approach to improving patient safety in the acute, primary, and long-term care settings. Medication reconciliation is limited in the primary care setting by the quality of information from patients and family members about not only what patients are taking but also how they are taking it. Over-the-counter medications are often not routinely reported by patients despite the risk of contraindications. Overall, efforts to improve medication safety in primary care should improve not only safety, including reductions in adverse drug events, but also quality of care.

Family Engagement in Care

Family engagement has been proposed as a potential solution to improving patient safety. Since patients are often cared for or influenced by their families, caregivers, and social networks, integrating the family into safety and quality of care activities may be an important strategy to consider. One study found that for short-term interventions, integration of the family increased medical adherence through simple interventions such as check-ins with a family member or daily documentation. However, the study was inconclusive on the effect on management of chronic health issues.⁶⁰

In another study, families were trained to participate in medical triage, making calls following a carefully designed protocol. Results were mixed as family activations were not taken as seriously as those from a practitioner, yet families were often accurate in identifying medical needs at home.⁶⁰ These studies suggest that to take full advantage of patient partnerships in primary care to improve safety, providers should also consider the family an integral part of the relationship.

Structured Communication for Patients, Families, and Primary Care Providers

Strategies to support structured communication for patients, family members, and providers have been proposed as important to improving patient safety in primary care. Many of the educational resources for patients and families encourage patients to:

• Have a checklist to prepare for their doctor’s visit,
• Bring a list of questions,
• Write out their symptoms if they have trouble communicating with the doctor during the visit, and
• Bring a family member or friend to visits, particularly when significant health concerns are being discussed.^{41,43,57,58,60,62,141,177,179,204,222,225,257–260}

Evidence of the impact of tools to support question asking is suggestive and case based at best. A recent consensus report from the United Kingdom recommended a checklist for primary care providers to structure communication within the patient encounter.⁴³ This checklist was generated following a comprehensive synthesis of evidence pertaining to patient safety errors in primary care and strategies to overcome them. Checklists for patients and providers may support broad adoption of information seeking within the patient-provider relationship and are worth consideration.