@article{ref1,
title="A pragmatic clinical trial approach to assessing and monitoring suicidal ideation: results from a national US trauma care system study",
journal="Psychiatry interpersonal and biological processes",
year="2021",
author="Engstrom, Allison and Moloney, Kathleen and Nguyen, Jefferson and Parker, Lea and Roberts, Michelle and Moodliar, Rddhi and Russo, Joan and Wang, Jin and Scheuer, Hannah and Zatzick, Douglas",
volume="ePub",
number="ePub",
pages="ePub-ePub",
abstract="OBJECTIVE: 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. <br><br>METHOD: 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. <br><br>RESULTS: 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). <br><br>CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02655354.<p /> <p>Language: en</p>",
language="en",
issn="0033-2747",
doi="10.1080/00332747.2021.1991200",
url="http://dx.doi.org/10.1080/00332747.2021.1991200"
}