On September 9, 2009, President Obama directed the Secretary of the U.S. Department of Health and Human Services (HHS) to establish an initiative to help States and health care systems test new models of care delivery, adverse event disclosure, and dispute resolution, with the joint aims of (1) putting patient safety first by reducing preventable injuries, (2) fostering better communication between doctors and patients, (3) ensuring fair and timely compensation for medical injuries while reducing malpractice litigation, and (4) reducing liability premiums.
In response, the Secretary launched the HHS Patient Safety and Medical Liability Initiative in October 2009. Under this initiative, the Agency for Healthcare Research and Quality (AHRQ) funded 13 planning grants totaling $3.5 million. These funds aimed to help States, health systems, and risk management organizations plan for new programs, expand or modify existing resources, and conduct feasibility studies to explore the early phases of implementation and testing. The planning grants were originally scheduled to run for 1 year beginning in late summer 2010. Many of the grantees requested and received no-cost extensions of varying lengths. All the planning grants were completed by December 2012.
The planning grants were designed to provide initial funding to States and health systems so they could explore new initiatives that address patient safety and medical liability. Given their limited budget and time period, it was anticipated that the planning grants would result solely in preliminary findings, primarily lessons learned from laying the groundwork for future patient safety and medical liability reform projects.
In general, the funded projects covered three main areas, although there was some overlap in activities: (1) improving communication by assessing attitudes toward error and harm disclosure and implementing clinical communication interventions; (2) improving patient safety by measuring safety problems, characterizing adverse events, and conducting clinical safety interventions; and (3) exploring resolution methods as a means to divert potential claims out of the malpractice system.
Below, Table 1 lists each of the 13 projects, highlighting the project’s main focus and summarizing selected findings. More detail about the individual projects (e.g., principal investigator, grant award amounts, goals, methods, activities) can be found in the grantee profiles in Appendix A.
Several general observations can be made about the experiences of the planning grants. Grantees who sought to improve communication learned that the beliefs, preferences, and behaviors of physicians play a key role in facilitating or impeding the adoption of new practices and processes. Taking the time to identify areas of shared agreement and concern regarding communication between patients and providers can help hone communication improvement efforts. Activities undertaken by the grantees that sought to improve patient safety appear to effectively identify the causes of and contributors to medical errors, and there appear to be some promising interventions and strategies available to prevent or minimize them. And finally, promising alternative models exist for reducing liability costs and, at the same time, improving patient safety.
|Areas of Focus||Organization||Summary of Selected Findings|
|Carilion Medical Center||This project identified four obstetric events that varied in terms of risk and liability, but all required provider teamwork and the involvement of the patient and family members. About half of the identified individual, team, and system failures associated with these events were common to all four, suggesting that systemic changes could mitigate multiple events. Patients and family members who participated in an adapted TeamSTEPPS® training program demonstrated knowledge improvement in medical communication and teamwork, suggesting that the intervention may improve patient knowledge.|
|University of Washington||Researchers planned for and implemented a shared decisionmaking (SDM) model in spine surgery clinics. The project culminated in the development of a train-the-trainer toolkit that integrates the processes developed and lessons learned. The toolkit is available online and can be implemented in other settings. A separate analysis of patient complaints indicated that 78% involved an element of informed consent or SDM and suggested that complaints involving informed consent or SDM represent significant potential cost savings.|
|University of Utah||This project developed a 10-step protocol for disclosing unanticipated medical outcomes and implemented it across a large regional health system with a long history of collaboration and an established culture of patient safety. The protocol appears to be easily taught and well received by patients, family members, and physicians. A center was established at the University’s School of Medicine to promote the inclusiveness of medical communication.|
|Sanford Research||This project successfully planned for and implemented a Patient Advocacy Reporting System—which uses patient complaints to identify and intervene with physicians with high complaint levels—in a large multistate health care system. Analysis of previously collected patient complaint data suggests that patient complaints may be a predictor of adverse events.|
|Improving Patient Safety||Washington State University||The project found that medication discrepancies in the transition from hospital to home care occurred across all types of medications and in 41% of cases sampled in this study may have caused adverse drug events. Risk can be minimized with solutions that integrate medication risk management efforts into transitional care models.|
|Johns Hopkins University||Analysis of hospital claims showed that suboptimal care at hospital discharge accounted for a considerable proportion of malpractice claims and involved failures in multiple domains of the hospital work system. To fill a gap in existing tools, two surveys were developed and tested to assess care transition quality and identify patients at risk of safety problems at hospital discharge. The instruments can be further tested and revised for broader use.|
|North Carolina Department of Health and Human Services||Pilot testing of a near-miss and remediation reporting system in primary care practices indicated that nearly half of near-miss events involved office administration, electronic medical records were associated with 14% of errors, and some of the near misses would likely have compromised patient safety. No significant implementation barriers were identified, and some sites continued to use the system. The project showed that near-miss reporting systems can be implemented for a fairly minimal cost and be used effectively to identify and remediate potential contributors to medical errors.|
|The Ohio State University||Researchers successfully developed and refined a Pregnancy Associated Mortality Review (PAMR) for the State of Ohio. This work resulted in PAMR data and contributed to preliminary quality improvement initiatives to improve death certificate data, educate providers, evaluate readiness for patient safety initiatives, conduct reviews of maternal morbidity, and enhance stakeholder networking.|
|Jackson Memorial Hospital||Researchers developed and pilot tested the Initiative to Reduce Inpatient Suicide model to intervene with hospitalized medical/surgical patients at risk for suicide. Pilot test results indicate a high rate of suicide risk among patients receiving inpatient care. More work is needed to improve the screening instrument, increase adherence to the model, and further train nurses in detecting and managing at-risk patients.|
|Exploring Resolution Methods||Beth Israel Deaconess Medical Center||The project resulted in a roadmap for starting a disclosure, apology & offer (DA&O) program in Massachusetts, historic partnerships between stakeholders coming to consensus on DA&O legislation, and State legislation allowing health care organizations to develop DA&O programs to settle malpractice claims. Stakeholders strongly supported the model because it is “the right thing to do” and can potentially improve patient safety, promote fairness and trust, and reduce costs.|
|Multicare Health System||This grant resulted in the development of criteria for Avoidable Classes of Events that would also be Automatically Compensable Events (ACEx2), a list of 18 events meeting these criteria, components of the ACEx2 model, a standardized approach to compensation, and recommendations for implementing ACEx2 in lieu of the current tort system in the Seattle, Washington, area.|
|Wishard Health Services (now subsumed under Eskenazi Health)||The project evaluated a new claims model, which features peer review, apology, and offer. Staff rated the new system favorably. Claims processed through the new system fared better than or the same as those processed through the old system.|
|Office for Oregon Health Policy and Research||This project concluded that the safe harbor approach appears to be valuable for improving patient safety but less so for reducing medical liability costs. A significant challenge to this approach may be the difficulty in achieving consensus on evidence-based clinical guidelines.|