Large-scale adverse events (LSAE) are unanticipated outcomes resulting directly from medical care involving three or more patients. Currently, the healthcare system struggles to determine how best to communicate with patients during LSAEs. We seek to identify optimal communication strategies to minimize harm and unintended consequences following disclosure. We will use 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 addresses 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 is a directed content analysis of media reports for six past VA LSAEs to create strategies for how the VA can work with stakeholders during a LSAE. Study Two involves interviews with Veterans, staff, and leadership at nine facilities that have disclosed LSAEs in the past (97 total interviews), to determine what communication went well and what needs improvement. Study Three examines the unintended consequences of notification by analyzing VA and Medicare cost and healthcare utilization data sets from past LSAEs. Study Four involves creating LSAE vignettes depicting different infection risk levels, and vary by the notification medium. This internet-based survey's (1,013 participants) key measures include trust in VA and willingness to have follow-up testing. Study Five tests the effectiveness of a toolkit and training with up to four VA facilities planning for disclosure. Following implementation, qualitative interviews will be conducted.
Studies One, Two and Three have completed data analysis. Study One found 148 unique media reports resulted 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 an 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 VHA for healthcare services by 18 months post-exposure.
Currently, VA LSAE disclosures take place without the help of evidence about how best to communicate this information in a way that minimizes harm to patients and maximizes trust. The impact on employees is also unknown. This study will help the VHA better understand what aspects of this communication can be improved to minimize confusion and distress by those involved.
- 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.
- 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 Annual Meeting; 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.
Adverse Event Monitoring, Best Practices, Management and Human Factors, Patient-Provider Interaction