A Pragmatic Clinical Trial Approach to Assessing and Monitoring Suicidal Ideation: Results from A National US Trauma Care System Study

• Published in: Psychiatry (Washington, D.C.) Vol. 85; no. 1; pp. 13 - 29
• Main Authors: Engstrom, Allison, Moloney, Kathleen, Nguyen, Jefferson, Parker, Lea, Roberts, Michelle, Moodliar, Rddhi, Russo, Joan, Wang, Jin, Scheuer, Hannah, Zatzick, Douglas
• Format: Journal Article
• Language: English
• Published: United States Routledge 01.01.2022
• Subjects: Emergency Medical Services; Humans; Suicidal Ideation; Suicide - psychology; Suicide Prevention; Survivors
• ISSN: 0033-2747; 1943-281X
• DOI: 10.1080/00332747.2021.1991200

Few investigations have comprehensively described methods for assessing and monitoring suicidal ideation in pragmatic clinical trials of mental health services interventions. This investigation's goal was to assess a collaborative care intervention's effectiveness in reducing suicidal ideation and describe suicide monitoring implementation in a nationwide protocol. The investigation was a secondary analysis of a stepped wedge cluster randomized trial at 25-Level I trauma centers. Injury survivors (N = 635) were randomized to control (n = 370) and intervention (n = 265) conditions and assessed at baseline hospitalization and follow-up at 3-, 6- and 12-months post-injury. The Patient Health Questionnaire (PHQ-9) item-9 was used to evaluate patients for suicidal ideation. Mixed model regression was used to assess intervention versus control group changes in PHQ-9 item-9 scores over time and associations between baseline characteristics and development of suicidal ideation longitudinally. As part of the study implementation process assessment, suicide outreach call logs were also reviewed. Over 50% of patients endorsed suicidal ideation at ≥1 assessment. Intervention patients relative to control patients demonstrated reductions in endorsements of suicidal ideation that did not achieve statistical significance (F[3,1461] = 0.74, P = .53). The study team completed outreach phone calls, texts or voice messages to 268 patients with PHQ-9 item-9 scores ≥1 (n = 161 control, n = 107 intervention). Suicide assessment and monitoring can be feasibly implemented in large-scale pragmatic clinical trials. Intervention patients demonstrated less suicidal ideation over time; however, these comparisons did not achieve statistical significance. Intensive pragmatic trial monitoring may mask treatment effects by providing control patients a supportive intervention. ClinicalTrials.gov NCT02655354