Commit resources to a longer-term effort to address the intersection of patient safety and medical liability.
AHRQ was asked by the Secretary of HHS to use its authority under 42 USC 299a(a) to support the President’s PSML initiative as part of its Patient Safety Portfolio. AHRQ has provided leadership over the past 5 years to this effort. The current portfolio of PSML demonstration and planning grants can reasonably be viewed as the first and formative step in a longer-term effort to build models and national capacity for tracking and evaluating new policies and programs on medical liability and patient safety. The President directed the Agency to “move forward on a range of ideas about how to put patient safety first …,” and these first pilot projects did just that. They were investigator-initiated models—a “let every flower bloom” approach to model development. Given the dearth of evidence on program models, this approach made sense. Grantees learned as they implemented, and the field has benefited from the experience of the current PSML portfolio, including better understanding of the implementation challenges and facilitators, the relevant types and potential sources of performance data, as well as now having access to preliminary data on promising models, which should heavily influence efforts going forward.
A reasonable next step for AHRQ to take is to incorporate what was learned through the PSML demonstration and planning grants with the learnings from the subsequent projects (Safety Program for Perinatal Care and CANDOR) to identify the most promising models for a much more rigorous “road test” in multiple host organizations around the country. In a second stage of the PSML initiative, we recommend that AHRQ consider sponsoring a true multi-site demonstration program within which multiple host organizations would implement the same model program, albeit under different local conditions. In this demonstration, a particular focus should be placed on (1) planning for, monitoring, and troubleshooting implementation of the chosen program model; (2) creating a realistic timeline for the grants that allows for full program implementation before data collection begins; (3) designing an overarching evaluation that will yield high-quality evidence of effectiveness and implementing that evaluation design across sites; and (4) choosing investigators and host organizations that have demonstrated a capacity for longitudinal data collection.
Proactively address data challenges in future PSML initiatives.
After completing an inventory of data systems and measures in the first year of the PSML evaluation, we identified a series of major challenges to using existing secondary data systems to assess the impact of the PSML demonstration projects. For the future, two implications follow. First, the field may need more investment and national infrastructure development to improve common datasets and measures relating to PSML outcomes, particularly around malpractice claiming. Second, at least in the near term, future PSML demonstration projects are likely to continue collecting their own primary data, based on thoughtful decisions upfront about the most relevant and useful outcome measures. In fact, a number of the PSML demonstration projects invested substantial resources to create data collection instruments that can be repurposed for future initiatives (e.g., the REDCAP data collection instruments used in the New York project for both DRPs and the JDN program). One problem the various sites faced, though, was that investigators were building “Cadillac” data collection systems that simply could not be sustained after the grant ended. Researchers working with clinicians and risk managers need to reduce the burden of such data collection so that monitoring can be sustained in “real-world” host organizations after the grant period is over.
Support studies to test additional “best practices” for their impact on reducing malpractice exposure.
Two of the PSML demonstration projects (Ascension and Fairview) focused on reducing variation in care by implementing evidence-based guidelines and processes to improve clinical practice in labor and delivery. Another project (PROMISES) focused Much of the development of these types of quality improvement efforts, including the development of TeamSTEPPS® training protocols, specific patient care bundles, checklists, and other tools, has originated with AHRQ and with AHRQ-funded investigators. Future work in this area would be a natural extension of AHRQ’s existing efforts to disseminate and encourage the uptake of models (such as the development and implementation of bundles) aimed at reducing variation in care and improving patient safety across the country. Under an extended PSML portfolio, investigators could be encouraged to focus on risks that contribute to large numbers of medical errors and to investigate the effects of remediating interventions on malpractice as well as clinical outcomes.
Fund more exploratory work examining the role of patients and families in the investigation and remediation of patient safety problems.
The UT and UW demonstration projects explored the questions, “What should be the role (if any) for patients and their family members in adverse event reporting, investigation, and remediation? What can patients and family members (potentially) add to the information that hospitals and ambulatory practices already gather in root cause analysis and other investigatory processes? What (if anything) is unique about the contribution the patient voice can make to a ‘learning organization’? Can patients participate in root cause analysis and/or processes of quality improvement (such as LEAN) and, if so, how?” These are all intriguing questions that have been raised, but not answered, by the work of these grantees. More work in this area is needed.
Consider adding a “disclosure culture” module to the AHRQ patient safety culture survey.
The UT project developed and conducted preliminary psychometric testing of a module on disclosure culture that could be integrated into any existing patient safety culture survey. Given that AHRQ’s survey is broadly used in the field, to advocate the addition of a disclosure culture module would raise consciousness of disclosure issues and begin to change the conversation nationally.
Include in the AHRQ Clearinghouse all of the tools, training packages, and products developed by the PSML demonstration grantees.
As we have noted earlier in this report, possibly the most important impact of this initiative will come from the various tools, training packages, program models, videos, slide decks, publications, and other products produced by the grantees for their own programs. Wide dissemination of these products by AHRQ is in keeping with the goals of the initiative—to enhance the diffusion of program-related interventions beyond the specific projects.
