Veteran and Staff Perceptions of VHA Large Scale Adverse Event Communications

描述（由申请人提供）： 退伍军人事务部（VA）承认不良事件的三种披露类型：1）临床披露，2）机构披露和3）大规模披露。关于大规模不良事件（定义为涉及三名或三名以上患者）通知的决定由卫生部首席副部长（PDUSH）与临床审查委员会（CRB）协商后根据退伍军人健康结果事件的暴露概率和严重程度制定。大规模的不良事件沟通是独特的，因为许多退伍军人可能暴露，但很少有人真正面临传染病的风险。 与我们的业务合作伙伴-PDUSH办公室，公共卫生办公室（10 P3），艾滋病毒/肝炎QUERI和卫生经济学资源中心（HERC）合作-我们制定了关键的研究问题，这些问题反映了VHA领导层在决定通知退伍军人患者感染控制违规后的潜在感染风险时的担忧。 我们将采用危机和紧急风险沟通模型的概念模型，以确定最佳的、以患者为中心的沟通策略，以最大限度地降低在几个沟通时间点进行大规模披露后的伤害和意外后果风险：（1）初始沟通;（2）维护沟通;（3）解决沟通和（4）随访/评估沟通。我们目前在临床披露方面的工作表明，理想的沟通发生在几个时间点上，每次都有不同的目的。我们的四个阶段的研究涉及定性和定量的方法，将解决三个关键的短期目标，在这个服务导向的研究建议：（1）探讨退伍军人大规模的不良事件对退伍军人的影响，他们的家人，和VHA工作人员的看法，退伍军人服务，自我风险，和情绪反应的通知;（2）确定过去VA通知程序对意外结果的影响，如退伍军人和VHA工作人员的焦虑和痛苦，退伍军人对VA的信任，行动的自我效能，对伤害风险的看法，以及VA医疗保健利用的变化和成本;（3）根据SDR中收集的关于退伍军人对VA的信任、焦虑和痛苦、行动自我效能的证据，实证检验不同通知程序和语言模式的有效性， 损害风险的感知以及成本和利用率的降低或增加。我们的长期目标是开发一个大规模不良事件通知工具包，该工具包可由B PDUSH、CR B和我们的10 P3合作伙伴分发给VHA和医疗中心领导层，以便在发生大规模不良事件后通知退伍军人可能的感染风险时使用 在VHA设施中接受护理。研究1将涉及对媒体报道和以往通知函的内容分析，以便在今后的披露中为媒体和传播战略提供信息。研究2涉及采访退伍军人，他们的家人，VHA工作人员和领导在六个VHA设施谁披露了大规模的不良事件在过去两年。这些访谈将受益于VHA系统用户、其家人以及受不良事件和披露流程影响最大的员工的经验，以更多地了解哪些措施有效，哪些措施需要在未来的战略中加以改进。研究3将通过分析VA和Medicare成本和医疗保健利用数据集来检查不良事件通知的意外后果。我们将设法了解退伍军人在披露后是否留在VHA系统中，他们是否在VA之外寻求护理，费用是否减少或增加，以及任何变化恢复到基线所需的时间。研究4将建立在前三项研究的基础上，通过创建描述不同感染风险水平（高与低）和不同类型的大规模不良事件（牙科与结肠镜检查）的大规模披露小插图，这些小插图将因通知媒介（来自VHA机构的电话、信件或两者）而异。我们将通过实验来操纵这些变量，以确定对伤害风险感知、对VA的信任、行动自我效能和 危险等级这些发现将最终导致开发一个大规模的不良事件工具包，通过卫生部首席副部长和公共卫生办公室广泛分发。未来的前瞻性研究，建议在一个实际的大规模不良事件披露过程中的工具包的传播和实施进行评估。

DESCRIPTION (provided by applicant): The Department of Veterans Affairs (VA) recognizes three types of disclosure of adverse events: 1) clinical disclosure, 2) institutional disclosure and 3) large scale disclosure. Decision regarding notification of large scale adverse events, defined as involving three or more patients, are made by the Principal Deputy Under Secretary of Health (PDUSH) in consultation with the Clinical Review Board (CRB) following guidelines based on probability of exposure and severity of the event on Veterans' health outcomes. Large scale adverse event communication is unique in that many Veterans are potentially exposed but few are truly at risk of infectious disease. Working with our operational partners-Office of the PDUSH, Office of Public Health (10P3), HIV/Hepatitis QUERI and the Health Economics Resource Center (HERC)--we have developed key research questions which reflect VHA leadership concerns when making decisions to notify Veteran patients of potential risks of infection following infection control breaches. We will employ a conceptual model of Crisis and Emergency Risk Communication model to identify optimal, patient-centered communication strategies to minimize risk of harm and unintended consequences following large scale disclosure over several communication time points: (1) initial communication; (2) maintenance communication; (3) resolution communication and (4) follow-up /evaluative communication. Our current work on clinical disclosures shows that ideal communication occurs over several time points and serves different purposes at each time. Our four staged studies involving qualitative and quantitative methodologies will address three key short-term objectives in this Service Directed Research proposal: (1) To explore the effect of VA large scale adverse events on Veterans', their families', and VHA staff perceptions of VA services, risk to self, and emotional responses to notification; (2) To determine the impact of past VA notification procedures on unintended outcomes, such as Veterans' and VHA staff anxiety and distress, Veterans' trust in the VA, self-efficacy for action, perceptions of risk of harm, and changes and cost in VA healthcare utilizations; (3) To empirically test the effectiveness of different models of notification procedures and language based on evidence collected in the SDR on Veterans' trust in the VA, anxiety and distress, self-efficacy for action, perceptions of risk of harm and decreased or increased cost and utilization. Our long-term objective is to develop a large scale adverse event notification tool kit that can be distributed b the PDUSH, CRB and our 10P3 partners to VHA and medical center leadership for use when notifying Veterans of possible risk of infection following large scale adverse events that occurred in VHA facilities where they received care. Study 1 will involve a content analysis of media reports and past notification letters to inform media and communication strategies in future disclosures. Study 2 involves interviews with Veterans, their families, VHA staff and leadership at the six VHA facilities who have disclosed large scale adverse events in the past two years. These interviews will benefit from the experiences of users of the VHA system, their families, and the staff affected most by the adverse event and disclosure process, to understand more about what worked and what needs to be improved in future strategies. Study 3 will examine the unintended consequences of adverse event notification by analyzing VA and Medicare cost and health care utilization data sets. We will seek to understand whether Veterans stayed in the VHA system following disclosure, whether they sought care outside the VA, whether costs decreased or increased, and the time it took for any changes to return to baseline. Study 4 will build on the previous three studies by creating large scale disclosure vignettes depicting different infection risk levels (high vs. low), and different types of large scale adverse events (dental vs. colonoscopy) which will vary by the notification medium (phone call, letter or both from VHA facilities). We will experimentally manipulate these 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 large scale adverse event tool kit for wide distribution through the Principal Deputy Under Secretary for Health and the Office of Public Health. A future prospective study is proposed to evaluate the dissemination and implementation of the tool kit during an actual large scale adverse event disclosure process.