基于在线评估的物质相关障碍患者的独立于部门的治疗协调的有效性和成本效益（ASSIST）：一项随机对照试验的研究方案。

Effectiveness and cost-effectiveness of sector-independent treatment coordination for people with substance-related disorders following an online assessment (ASSIST): study protocol for a randomized controlled trial.

机构信息

Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany.

Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany.

出版信息

Trials. 2022 Jun 1;23(1):448. doi: 10.1186/s13063-022-06343-4.

DOI:10.1186/s13063-022-06343-4

PMID:35650629

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9156834/

Abstract

BACKGROUND

The implementation of person-centred, need-oriented and flexible care for people with substance-related problems is often insufficient, in large part due to the complexity of addiction support services among different providers. A standardized online assessment and subsequent sector-independent treatment coordination could provide individuals with more appropriate services, thereby making better use of individual services and leading to a more effective addiction support system as a whole. The aim of this study is to determine the effectiveness and cost-effectiveness of sector-independent treatment coordination following an online assessment, in comparison with the current standard of care and treatment process in Germany.

METHODS

The sample size of this randomized, controlled trial has been set to a total of 400 participants with substance-related problems. Participants living in Stuttgart, Germany, will be randomly allocated to (1) the intervention group with immediate online assessment and subsequent sector-independent treatment coordination (ASSIST) or (2) the waitlist group. Participants in the waitlist group will initially remain in usual care and only be provided with the online assessment 6 months later. Short-term effects (over 2 months) and medium-term effects (over 6 months) of ASSIST will be compared between the intervention and the waitlist groups. The primary outcome is improved treatment satisfaction. Secondary outcomes include improved subjective quality of life and empowerment, reductions in patients' substance use, unmet needs and illness-related clinical and social impairment. Health economic evaluation as well as quantitative and qualitative process evaluations will be conducted.

DISCUSSION

The results of this study are expected to provide information on whether sector-independent treatment coordination following an online assessment contributes to improved health care service provision for people with substance-related problems. This randomized controlled trial will help identify facilitators and barriers to the sustainable implementation of a cross-sectoral care concept in substance abuse services.

TRIAL REGISTRATION

German Clinical Trial Register DRKS00026996 . Registered on 29 October 2021.

摘要

背景

在很大程度上，由于不同提供者的成瘾支持服务的复杂性，以患者为中心、以需求为导向和灵活的针对物质相关问题患者的护理实施往往不足。标准化的在线评估和随后的独立于部门的治疗协调，可以为个人提供更合适的服务，从而更好地利用个人服务，并导致整体上更有效的成瘾支持系统。本研究的目的是确定在线评估后独立于部门的治疗协调与德国当前的护理标准和治疗流程相比的有效性和成本效益。

方法

本随机对照试验的样本量设定为总共 400 名有物质相关问题的参与者。居住在德国斯图加特的参与者将被随机分配到（1）干预组，即立即进行在线评估和随后的独立于部门的治疗协调（ASSIST），或（2）候补组。候补组的参与者最初将继续接受常规护理，仅在 6 个月后提供在线评估。将比较 ASSIST 对干预组和候补组的短期（2 个月内）和中期（6 个月内）效果。主要结果是治疗满意度的提高。次要结果包括主观生活质量和赋权的提高、患者物质使用的减少、未满足的需求以及与疾病相关的临床和社会功能障碍的减少。将进行健康经济评估以及定量和定性的过程评估。