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

Abstract

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. 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. 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. 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. 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. 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.