Electronic protocol for suicide risk management in research participants

Abstract

Objective: To describe an electronic, telephone-delivered, suicide risk management protocol (SRMP) that is designed to guide research staff and safely triage study participants who are at risk for self-harm.

Methods: We tested the SRMP in the context of the NIH-funded randomized clinical trial "Bypassing the Blues" in which 302 patients who had undergone coronary artery bypass graft surgery (CABG) were screened for depression and assessed by telephone 2-weeks following hospital discharge and at 2-, 4-, and 8-month follow-up. We programmed the SRMP to assign different risk levels based on patients' answers from none to imminent with action items for research staff keyed to each of them. We describe frequency of suicidal thinking, SRMP use, and completion of specific steps in the SRMP management process over the 8-month follow-up period.

Results: Suicidal ideation was expressed by 74 (25%) of the 302 study participants in 139 (13%) of the 1069 blinded telephone assessments performed by research staff. The SRMP was launched in 103 (10%) of assessments, and the suicidal risk level was classified as moderate or high in 10 (1%) of these assessments, thereby necessitating an immediate evaluation by a study psychiatrist. However, no hospitalizations, emergency room visits, or deaths ascribed to suicidal ideation were discovered during the study period.

Conclusion: The SRMP was successful in systematically and safely guiding research staff lacking specialty mental health training through the standardized risk assessment and triaging research participants at risk for self-harm.

Trial registration: Clinicaltrials.gov Identifier: NCT00091962 (https://ichgcp.net/clinical-trials-registry/NCT00091962?term=rollman+cabg&rank=1).

Keywords: Clinical trial; Coronary artery bypass graft; Depression; Electronic research protocol; Suicidal ideation.

Published by Elsevier Inc.

Figures

Figure 1

Suicide risk management protocol (SRMP). Rhombuses show points at which risk evaluations occur, and rectangles show components of the SRMP. *Eight risk factors for self-harm are assessed: previous attempt, moderate or greater level of depression, current alcohol abuse, current perceived stress, psychiatric comorbidity (depression, anxiety), lack of social support, poor impulse control, and access to weapons. Abbreviations: HRS-D, Hamilton Rating Scale for Depression; PHQ-9, 9-item Patient Health Questionnaire; SSI, Scale for Suicide Ideation.