Large-scale adverse events (LSAE) are unanticipated outcomes resulting directly from medical care involving three or more patients. In the past, the VA struggled to determine how best to communicate with patients during LSAEs. We identified optimal communication strategies to minimize harm and unintended consequences following disclosure. We used the Crisis and Emergency Risk Communication model developed by the CDC to guide our study objectives and methodology.
Our five-part study involving qualitative and quantitative methodologies addressed four key objectives: (1) explore the effect of LSAEs on Veterans', families', and staff perceptions of VA services, risk to self, and emotional responses to notification; (2) determine the impact of past notification procedures on unintended outcomes, such as Veterans' and staff anxiety and distress, trust in the VA, and changes in VA healthcare utilizations; (3) empirically test the effectiveness of different models of notification based on evidence collected; (4) develop, implement, and evaluate a LSAE toolkit in partnership with VACO.
Study One was a directed content analysis of media reports for six past LSAEs to create strategies for how the VA can work with stakeholders during a LSAE. Study Two involved qualitative interviews with Veterans, staff, and leadership at nine facilities with past LSAEs, to determine what communication went well and what needs improvement. Study Three examined the unintended consequences of notification by analyzing VA and Medicare cost and healthcare utilization data sets from five past LSAEs. Study Four used LSAE vignettes depicting different infection risk levels, and which varied by the notification medium to test new communications language/methods. The internet-based survey's key measures included trust in VA and willingness to have follow-up testing. Study Five was an implementation study. A Toolkit was implemented with two sites. An evaluation team conducted qualitative interviews to evaluate the toolkit and support services provided.
Study One analyzed 148 unique media reports resulting from the six VA events. Some components of effective communication (discussion of cause, reassurance, self-efficacy) were more often present than others (apology, lessons learned). References to "promoting secrecy" and "slow response" appeared most often in media coverage when time from event discovery to notification was over 75 days. Elected officials were quoted often (n=115) with comments that were predominantly negative in tone (83%).
Study Two included 97 interviews. Many areas for improvement during disclosure were identified, such as preparing facilities better (pre-crisis), creating rapid communications, modifying disclosure language, addressing perceptions of harm, reducing complexity (initial event), managing communication with stakeholders (maintenance), minimizing effects on staff and improving trust (resolution), addressing facilities' needs (evaluation).
Study Three examined five past LSAEs. Receipt of a LSAE notification was associated with adjusted odds of 49.7 (95% CI 41.2 - 60.0), 103.8 (95% CI 78.1 - 137.9) and 88.4 (95% CI 70.4 - 110.0), for HCV, HIV and HBV testing, respectively. LSAEs were associated with changes in subsequent utilization patterns. Patients exposed to a dental LSAE reduced their use of preventive and restorative dental care over the subsequent year, but eventually came back to VA for healthcare services by 18 months post-exposure.
Study Four found high-risk framing relative to low-risk status-quo notification may promote increased behavioral intention to seek testing. Perceived risk of HIV/HBV/HCV is higher for those exposed to high-risk conditions versus low-risk conditions. Notification language process and risk did not significantly affect trust in VA or providers. The qualitative analysis supported the finding that low-risk adverse event guidance may be confusing to patients and more information is needed to clarify risk and follow up actions.
Study Five found that a toolkit with disclosure support services implemented through external facilitation demonstrates real promise. However, organizational barriers, especially the slow pace of large-scale disclosure decision processes, limited impact. For full dissemination and sustainment the investment of facility leadership, beyond national-level leadership, is needed.
Previously, VA LSAE disclosures took place without the help of evidence about how best to communicate this information in a way that minimizes harm to patients and maximizes trust. This study has helped the VA better understand what aspects of this communication can be improved to minimize confusion and distress by those involved. Leadership has taken steps to implement changes to LSAE disclosures, including involving the research team in CERT calls, recommending that facilities make phone calls before sending letters, eliminating the use of certified letters, and making improvements to the communications plan process to update language and methods used.
- Maguire EM, Bokhour BG, Wagner TH, Asch SM, Gifford AL, Gallagher TH, Durfee JM, Martinello RA, Elwy AR. Evaluating the implementation of a national disclosure policy for large-scale adverse events in an integrated health care system: identification of gaps and successes. BMC health services research. 2016 Nov 11; 16(1):648.
- Maguire EM, Bokhour BG, Asch SM, Wagner TH, Gifford AL, Gallagher TH, Durfee JM, Martinello RA, Elwy AR. Disclosing large scale adverse events in the US Veterans Health Administration: lessons from media responses. Public Health. 2016 Jun 1; 135:75-82.
- Wagner TH, Taylor T, Cowgill E, Asch SM, Su P, Bokhour B, Durfee J, Martinello RA, Maguire E, Elwy AR. Intended and unintended effects of large-scale adverse event disclosure: a controlled before-after analysis of five large-scale notifications. BMJ quality & safety. 2015 May 1; 24(5):295-302.
- Elwy AR, Bokhour BG, Maguire EM, Wagner TH, Asch SM, Gifford AL, Gallagher TH, Durfee JM, Martinello RA, Schiffner S, Jesse RL. Improving healthcare systems' disclosures of large-scale adverse events: a Department of Veterans Affairs leadership, policymaker, research and stakeholder partnership. Journal of general internal medicine. 2014 Dec 1; 29 Suppl 4:895-903.
- George J, Baker E, Burgess JF, Maguire EM, Elwy AR. Improving Patient Safety by Using Organizational Climate as a Leading Indicator to Assess Large-Scale Adverse Event Risk. Poster session presented at: AcademyHealth Annual Research Meeting; 2016 Jun 14; Boston, MA.
- Taylor TJ, Maguire EM, Gallagher TH, Bokhour BG, Asch SM, Gifford AL, Wagner DH, Durfee JM, Martinello RA, Elwy AR. Disclosing Healthcare System Adverse Events: Patients' Perceptions of Risk, Trust and Follow-up Behavior. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2015 Apr 22; San Antonio, TX.
- Elwy AR, Maguire EM, Bokhour BG, Asch SM, Gifford AL, Wagner TH, Gallagher TH, Durfee JM, Martinello RA, Jesse RL. Stakeholders’ perspectives on disclosing large scale adverse events: A toolkit built on lessons from implementing a national policy. Poster session presented at: National Institutes of Health / AcademyHealth Conference on the Science of Dissemination and Implementation; 2014 Dec 14; Bethesda, MD.
- Maguire EM, Bokhour BG, Durfee JM, Martinello RA, Asch SM, Gifford AL, Wagner TH, Gallagher TH, Elwy AR. Exploring Patient, Staff, and Leader Perceptions of Large Scale Adverse Event Notification Communication. Presented at: American Academy on Communication in Healthcare Research and Teaching Forum; 2014 Oct 4; Orlando, FL.
- Maguire EM, Elwy AR, Bokhour BG, Gifford AL, Asch SM, Wagner T, Gallagher TH, Durfee J, Martinello R. Communicating Large Scale Adverse Events: Lessons from Media Reactions to Risk. Presented at: AcademyHealth Annual Research Meeting; 2014 Jun 7; San Diego, CA.
- Maguire E, Elwy AR, Bokhour BG, Gifford AL, Asch SM, Wagner T, Burgess J, Martinello R. Communicating Large Scale Adverse Events: Lessons from Media Reactions to Risk. Paper presented at: American Academy on Communication in Healthcare Research and Teaching Forum; 2012 Oct 13; Providence, RI.
- George J, Elwy AR, Maguire EM, Baker E, Burgess JF, Charns MP, Meterko MM. Improving Patient Safety by Using Organizational Climate as a Leading Indicator to Assess Large-Scale Adverse Event Risk: Briefing before the Virtual presentation to the VA VISN and Medical Center Chief Medical Officer/Chief of Staff/Quality Management Conference Call, convened by the VA central office of the Assistant Deputy Undersecretary for Health for Clinical Operations; 2016 Sep 12; Bedford MA - virtual presentation.
- George J, Elwy AR, Maguire E, Baker E, Burgess JF, Charns MP, Meterko MM. Improving Patient Safety by Using Organizational Climate as a Leading Indicator to Assess Large-Scale Adverse Event Risk: Briefing before the Virtual presentation to the VA Clinical Executive Review Board convened by the VA central office of the Assistant Deputy Undersecretary for Health for Clinical Operations; 2016 Aug 1; Bedford, MA.
Adverse Event Monitoring, Best Practices, Management and Human Factors, Patient-Provider Interaction