Design of a multicenter randomized controlled trial of a post-discharge suicide prevention intervention for high-risk psychiatric inpatients: The Veterans Coordinated Community Care Study

IF 2.4 3区医学 Q2 PSYCHIATRY International Journal of Methods in Psychiatric Research Pub Date : 2024-10-01 DOI:10.1002/mpr.70003

Lauren M. Weinstock, Todd M. Bishop, Mark S. Bauer, Jeffrey Benware, Robert M. Bossarte, John Bradley, Steven K. Dobscha, Jessica Gibbs, Sarah M. Gildea, Hannah Graves, Gretchen Haas, Samuel House, Chris J. Kennedy, Sara J. Landes, Howard Liu, Alex Luedtke, Brian P. Marx, Aletha Miller, Matthew K. Nock, Richard R. Owen, Wilfred R. Pigeon, Nancy A. Sampson, Alejandro Santiago-Colon, Geetha Shivakumar, Snezana Urosevic, Ronald C. Kessler

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Abstract

Background

The period after psychiatric hospital discharge is one of elevated risk for suicide-related behaviors (SRBs). Post-discharge clinical outreach, although potentially effective in preventing SRBs, would be more cost-effective if targeted at high-risk patients. To this end, a machine learning model was developed to predict post-discharge suicides among Veterans Health Administration (VHA) psychiatric inpatients and target a high-risk preventive intervention.

Methods

The Veterans Coordinated Community Care (3C) Study is a multicenter randomized controlled trial using this model to identify high-risk VHA psychiatric inpatients (n = 850) randomized with equal allocation to either the Coping Long Term with Active Suicide Program (CLASP) post-discharge clinical outreach intervention or treatment-as-usual (TAU). The primary outcome is SRBs over a 6-month follow-up. We will estimate average treatment effects adjusted for loss to follow-up and investigate the possibility of heterogeneity of treatment effects.

Results

Recruitment is underway and will end September 2024. Six-month follow-up will end and analysis will begin in Summer 2025.

Conclusion

Results will provide information about the effectiveness of CLASP versus TAU in reducing post-discharge SRBs and provide guidance to VHA clinicians and policymakers about the implications of targeted use of CLASP among high-risk psychiatric inpatients in the months after hospital discharge.

Clinical trials registration

ClinicalTrials.Gov identifier: NCT05272176 (https://www.clinicaltrials.gov/ct2/show/NCT05272176).

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针对高风险精神病住院患者的出院后自杀预防干预多中心随机对照试验的设计：退伍军人社区协调护理研究》。

背景：精神病患者出院后是自杀相关行为（SRB）的高发期。出院后的临床推广虽然可能有效预防自杀相关行为（SRBs），但如果针对高风险患者，则会更具成本效益。为此，我们开发了一个机器学习模型来预测退伍军人健康管理局（VHA）精神病住院患者出院后的自杀行为，并针对高风险患者采取预防性干预措施：退伍军人社区协调护理（3C）研究是一项多中心随机对照试验，利用该模型确定高风险的退伍军人健康管理局（VHA）精神病住院患者（n = 850），将其随机等额分配到 "应对长期主动自杀计划"（CLASP）出院后临床外展干预或 "常规治疗"（TAU）中。主要结果是随访 6 个月的 SRB。我们将估算随访损失调整后的平均治疗效果，并调查治疗效果异质性的可能性：招募工作正在进行中，将于 2024 年 9 月结束。六个月的随访将于 2025 年夏季结束，分析将于 2025 年夏季开始：结果将提供有关CLASP与TAU在减少出院后SRB方面的有效性的信息，并为VHA临床医生和政策制定者提供指导，使他们了解在高风险精神病住院患者出院后的几个月内有针对性地使用CLASP的意义：临床试验注册：ClinicalTrials.Gov 识别码：NCT05272176 (https://www.Clinicaltrials: gov/ct2/show/NCT05272176)。

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来源期刊

International Journal of Methods in Psychiatric Research 医学-精神病学

CiteScore

5.20

自引率

6.50%

发文量

审稿时长

>12 weeks

期刊介绍： The International Journal of Methods in Psychiatric Research (MPR) publishes high-standard original research of a technical, methodological, experimental and clinical nature, contributing to the theory, methodology, practice and evaluation of mental and behavioural disorders. The journal targets in particular detailed methodological and design papers from major national and international multicentre studies. There is a close working relationship with the US National Institute of Mental Health, the World Health Organisation (WHO) Diagnostic Instruments Committees, as well as several other European and international organisations. MPR aims to publish rapidly articles of highest methodological quality in such areas as epidemiology, biostatistics, generics, psychopharmacology, psychology and the neurosciences. Articles informing about innovative and critical methodological, statistical and clinical issues, including nosology, can be submitted as regular papers and brief reports. Reviews are only occasionally accepted. MPR seeks to monitor, discuss, influence and improve the standards of mental health and behavioral neuroscience research by providing a platform for rapid publication of outstanding contributions. As a quarterly journal MPR is a major source of information and ideas and is an important medium for students, clinicians and researchers in psychiatry, clinical psychology, epidemiology and the allied disciplines in the mental health field.