Large-scale adverse events (LSAE) are unanticipated outcomes resulting directly from medical care involving three or more patients. Currently, the health care system struggles to determine the best way to communicate with patients during LSAEs especially as more information emerges. Our study seeks to identify optimal communication strategies to minimize risk of 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 four-part study involving qualitative and quantitative methodologies addresses three key short-term 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. Our long-term objective is to develop a LSAE notification toolkit that can be distributed by the VHA's Principal Deputy Under Secretary for Health and the Office of Public Health to medical center leadership for use in future LSAE notifications.
Study Part One involves a directed content analysis of media reports and notification letters for six past VA LSAEs and four non-VA events, to create strategies for how the VA can work with media and elected officials once a LSAE occurs. Study Part Two involves interviews with Veterans, their families, staff and leadership at nine facilities that have disclosed LSAEs in the past three years (97 total interviews), to determine what communication went well and what needs improvement for the future. Study Part Three examines the unintended consequences of adverse event notification by analyzing VA and Medicare cost and healthcare utilization data sets from past LSAEs. This part of the study examines whether Veterans stayed in the VHA system following disclosure, whether they sought non-VA care, whether costs decreased or increased, and the time it took for any changes to return to baseline. Study Part Four will involve creating large-scale disclosure vignettes depicting different infection risk levels, and different types of LSAEs which will vary by the notification medium. An estimated 740 Veterans will participate in this study via an internet-based survey. We will experimentally manipulate variables to determine the optimal responses to questions about perceptions of risk of harm, trust in VA, self-efficacy for action and distress levels. These findings will culminate in the development of a LSAE toolkit.
Study One and Study Three have completed data analysis. The media content 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 patient notification was over 75 days. Elected officials were quoted often (n=115) with comments that were predominantly negative in tone (83%). Hospital officials' comments (n=165) were predominantly neutral (92%), and focused on information sharing.
Study Three examined five past LSAEs. Receipt of an LSAE notification was associated with an 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. Compared to whites, African Americans were significantly less likely to return to VHA for follow-up testing. LSAEs were also 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 they eventually came back to VHA for healthcare services by 18 months post-exposure.
We are currently analyzing data from Study Two interviews and Study Four is underway.
Currently, VA LSAE disclosures take place without the help of evidence to guide decisions about how to disclose breaches of infection control practices, and without knowledge of how best to communicate this information in a way that minimizes harm to patients and maximizes their trust in the VA. Further, the impact on VHA employees of this breach in infection control practice and the resulting communication with Veterans and their families is 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