Allison Engstrom, Kathleen Moloney, Jefferson Nguyen, Lea Parker, Michelle Roberts, Rddhi Moodliar, Joan Russo, Jin Wang, Hannah Scheuer, Douglas Zatzick
{"title":"A Pragmatic Clinical Trial Approach to Assessing and Monitoring Suicidal Ideation: Results from A National US Trauma Care System Study.","authors":"Allison Engstrom, Kathleen Moloney, Jefferson Nguyen, Lea Parker, Michelle Roberts, Rddhi Moodliar, Joan Russo, Jin Wang, Hannah Scheuer, Douglas Zatzick","doi":"10.1080/00332747.2021.1991200","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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, <i>P</i> = .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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT02655354.</p>","PeriodicalId":49656,"journal":{"name":"Psychiatry-Interpersonal and Biological Processes","volume":null,"pages":null},"PeriodicalIF":2.7000,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8916972/pdf/nihms-1751704.pdf","citationCount":"2","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Psychiatry-Interpersonal and Biological Processes","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/00332747.2021.1991200","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/12/21 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PSYCHIATRY","Score":null,"Total":0}
引用次数: 2
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.
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.
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).
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.
期刊介绍：
Internationally recognized, Psychiatry has responded to rapid research advances in psychiatry, psychology, neuroscience, trauma, and psychopathology. Increasingly, studies in these areas are being placed in the context of human development across the lifespan, and the multiple systems that influence individual functioning. This journal provides broadly applicable and effective strategies for dealing with the major unsolved problems in the field.
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