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多学科生活方式为重点的方法治疗住院精神疾病患者的效果和实施（MULTI+）：一项阶梯式随机对照研究方案。

Effectiveness and implementation of a multidisciplinary lifestyle focused approach in the treatment of inpatients with mental illness (MULTI +): a stepped wedge study protocol.

机构信息

Scientific Research Department, GGz Centraal, Amersfoort, the Netherlands.

Department of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.

出版信息

BMC Psychiatry. 2022 Mar 31;22(1):230. doi: 10.1186/s12888-022-03801-w.

DOI:10.1186/s12888-022-03801-w

PMID:35361168

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8973631/

Abstract

BACKGROUND

People with mental illness have a reduced life expectancy compared to the general population. Despite the increasing evidence for the efficacy of lifestyle interventions there is little change in routine clinical care. This discrepancy is often referred to as the implementation gap and has caused a need for effectiveness and implementation research in real-world settings. Our study assesses the effectiveness and implementation of a multidisciplinary lifestyle focused approach in the treatment of inpatients with mental illness (MULTI +).

METHODS

An open cohort stepped wedge cluster randomized trial in inpatients psychiatric wards of GGz Centraal, the Netherlands. The wards are divided into three clusters based on geographical region. These clusters are randomly allocated to one of the three pre-defined steps to integrate MULTI + . MULTI + can be tailored to fit individual psychiatric wards and includes 10 core components aimed at improving lifestyle factors. The primary outcome is to investigate the difference in the mean QRISK3 score of patients receiving MULTI + compared to patients receiving TAU. Secondary outcomes include somatic and mental health outcomes, lifestyle factors, and implementation factors. Findings will be analysed using mixed model analyses.

DISCUSSION

The MULTI + study is the first large-scale study evaluating the long-term effects of a multidisciplinary, multicomponent approach aimed at improving lifestyle factors in routine inpatient mental health care. A limitation of this study is the risk of missing data due to the large-scale, real-world setting of this study. Furthermore, implementation monitoring and external events that may influence outcomes could be difficult to account for. Strengths of this study are the focus on effectiveness as well as implementation and the inclusion of both patient and health care professionals' perspectives. Effectiveness studies in routine clinical care can advance our knowledge on lifestyle interventions in real-world settings.

TRIAL REGISTRATION

ClinicalTrials.gov registration. Identifier: NCT04922749 . Retrospectively registered 3th of June 2021.

摘要

背景

与普通人群相比，精神疾病患者的预期寿命缩短。尽管越来越多的证据表明生活方式干预措施有效，但常规临床护理几乎没有改变。这种差异通常被称为实施差距，并导致需要在真实环境中进行有效性和实施研究。我们的研究评估了多学科、以生活方式为重点的方法在治疗精神疾病住院患者（MULTI +）中的有效性和实施情况。

方法

在荷兰 GGz Centraal 的精神科住院病房进行开放队列、分步楔形集群随机试验。这些病房根据地理位置分为三个集群。这些集群根据预先定义的三个步骤之一随机分配，以整合 MULTI +。MULTI + 可以根据个别精神科病房的情况进行调整，包括 10 个旨在改善生活方式因素的核心组成部分。主要结果是调查接受 MULTI + 的患者的 QRISK3 评分平均值与接受 TAU 的患者的评分平均值之间的差异。次要结果包括躯体和心理健康结果、生活方式因素和实施因素。研究结果将使用混合模型分析进行分析。

讨论

MULTI + 研究是第一项评估旨在改善常规住院精神卫生保健中生活方式因素的多学科、多成分方法的长期效果的大规模研究。该研究的一个局限性是由于研究的大规模、真实环境，存在数据缺失的风险。此外，实施监测和可能影响结果的外部事件可能难以考虑。该研究的优势在于关注有效性和实施，以及包括患者和医疗保健专业人员的观点。常规临床护理中的有效性研究可以提高我们对现实环境中生活方式干预的认识。