Evaluation of the Caring Letters Suicide Prevention Intervention after Removal of an Electronic Health Record Flag for Suicide Risk: An Effectiveness-Implementation Hybrid Type 2 Trial

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ABSTRACT In the electronic health record (EHR), the Veterans Health Administration (VHA) uses patient record flags during periods of high acute risk for suicide (e.g., following a suicide attempt) to alert clinicians and improve suicide prevention services. Unfortunately, recent analyses revealed that after these high-risk flags (HRFs) are discontinued based on clinical judgement, suicide rates remain high in the year that follows. This creates a suicide prevention challenge. To address this need, VHA facilities were required in 2020 to start implementing the Caring Letters suicide prevention intervention for this population. In the Caring Letters intervention, a series of messages are sent to individuals to communicate that they are not forgotten, and that people care about them and are concerned for their well-being. The messages also serve as a reminder that help is available. Multiple randomized clinical trials support the efficacy of Caring Letters for reducing suicide behaviors in acute care settings. The Joint Commission recently promoted Caring Letters, and the intervention is included in the VA/DoD suicide prevention Clinical Practice Guideline for acute care settings. Unfortunately, the mandate to use this intervention with Veterans with a discontinued HRF (VD-HRF) has faced many challenges. Less than half the facilities across the nation have implemented the program. For facilities that have implemented the program, several concerning fidelity problems have been identified, indicating that thousands of Veterans in those catchment areas are not receiving the intervention as intended. Therefore, we propose a partnered program evaluation between the VHA Suicide Prevention Program (SPP), and the proposed evaluation team to examine a new version of the intervention for this unique population. Specifically, the evaluation will randomize all VA facilities to either: (1) Centralized Caring Letters where all the work of administering Caring Letters is centralized with a single, national team (promoting high fidelity and compliance with the requirement), or (2) De-Centralized Caring Letters in which VA facilities continue their local procedures as usual during a 6- month delay before starting Centralized Caring Letters. We will conduct an effectiveness-implementation Hybrid Type 2 trial. As a Hybrid Type 2 trial, the study has dual primary goals. The first is to test the effectiveness of a Caring Letter campaign for VD-HRFs, a relatively new population for the intervention. The second goal is to evaluate the impact of adding an implementation strategy – centralizing the work of Caring Letters – to the existing strategy of mandating change. The evaluation will test two aims. In Aim 1, we will evaluate the effects of Caring Letters on clinical outcomes and VA clinical utilization rates. An exploratory aim will also examine rates of suicide attempts, all-cause mortality, and suicide for Veterans who receive Centralized Caring Letters compared to a historical cohort who received no Caring Letters. In Aim 2, we will evaluate the impact of adding the implementation strategy of centralizing the work of the intervention to the existing implementation strategy of mandating change. Using qualitative interviews, we will evaluate leadership, staff, and provider perspectives on the implementation and sustainability of Centralized Caring Letters. This will be one of the largest evaluations of a Caring Letters intervention ever conducted, and it will provide direct and actionable data to leadership to evaluate the impacts of this major prevention program.