Suicide Risk Management Protocol for a Randomized Controlled Trial of Cardiac Patients Reporting Hopelessness

Abstract

Background Investigators conducting studies that include potentially suicidal individuals are obligated to develop a suicide risk management (SRM) protocol. There is little available in the literature to guide researchers in SRM protocol development. Objectives The aim of the study was to describe an SRM protocol developed for a randomized controlled trial (RCT) currently enrolling cardiac patients who report moderate to severe levels of hopelessness. Methods The SRM protocol identifies suicidal ideation and measures ideation severity through use of the Columbia-Suicide Severity Rating Scale risk factor questions. Based on responses, study participants are deemed safe or at low, moderate, or high risk for suicide. The SRM protocol guides research staff through a plan of action based on risk level. The protocol further guides staff through a plan over the course of this prospective study—from hospital enrollment to home-based visits. Results Research staff are well trained to identify suicidal ideation risk factors, initiate specific questioning about suicidal intent, determine level of risk, identify protective factors and a safe environment, and make referrals if needed. Of the 51 patients hospitalized with cardiac disease who reported moderate to severe hopelessness, 43 scored at a safe suicide risk level and 8 scored at low risk. Thirty-five of the 51 patients enrolled in the RCT. Of the 35 participants who received home visits to date, there have been three instances of low and one instance of moderate suicide risk. The SRM protocol has been consistently and accurately used by research personnel in both hospital and home settings. One modification has been made to the protocol since study activation, namely, the addition of an assessment of counseling history and encouragement of continued counseling. Booster training sessions of research staff will continue throughout the course of the RCT. Discussion Use of the SRM protocol identifies study participants who are safe or at risk for suicide in both hospital and home settings, and research staff can refer participants accordingly. Conclusion The SRM protocol developed for this RCT can serve as a model in the development of SRM protocols for future research in acute care, community, or home-based settings.

Assessing suicidality during the SARS-CoV-2 pandemic: Lessons learned from adaptation and implementation of a telephone-based suicide risk assessment and response protocol in Malawi

“…The possibility of increasing suicide risk during the pandemic is concerning, and adapting and implementing a feasible, virtual protocol that addresses study participant suicide risk events and appropriately refers participants to care is critical [45]. Similar SRA protocols have been adapted for use in RCTs, but few have been developed in non-hospital, emergency, and time-sensitive contexts in which mental health care is severely disrupted [46][47][48][49].…”

“…Overall, transition from in-person to telephone-based SRAs was feasible and functioned well for patients and research team members. Providing a structured protocol is critical to providing research team members with the support and guidance needed to assess participant suicide risk [46]. The protocol identified participants at risk of suicide and referred participants to clinical settings when indicated.…”

Heart up! RCT protocol to increase physical activity in cardiac patients who report hopelessness: Amended for the COVID‐19 pandemic

“…The SRM protocol guides research staff through a plan of action based on risk level over the course of the study, from hospital enrollment to home‐based visits. A detailed description of the SRM protocol is available elsewhere (Dunn et al, 2020).…”