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基于社区的糖尿病合并抑郁症患者综合管理(CIC-PDD):一项群组随机对照试验研究方案。

Community-based integrated care for patients with diabetes and depression (CIC-PDD): study protocol for a cluster randomized controlled trial.

机构信息

School of Public Health, Peking University, Haidian District, 38 Xue Yuan Road, Beijing, 100191, China.

China Center for Health Development Studies, Peking University, Haidian District, 38 Xue Yuan Road, Beijing, 100191, China.

出版信息

Trials. 2023 Aug 22;24(1):550. doi: 10.1186/s13063-023-07561-0.

DOI:10.1186/s13063-023-07561-0
PMID:37608381
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10464429/
Abstract

BACKGROUND

Managing the multimorbidity of diabetes and depression remains a clinical challenge for patients and healthcare professionals due to the fragmented healthcare delivery system. To effectively cope with multimorbidity, there is an urgent need for the health system to transform into people-centered integrated care (PCIC) system globally. Therefore, this paper describes the protocol of community-based integrated care for patients with diabetes and depression (CIC-PDD) project, an integrated and shared-care intervention project.

METHODS/DESIGN: CIC-PDD project is conducted in two phases, namely "care model development" and "implementation and evaluation." In the first phase, CIC-PDD model was designed and developed based on the four criteria of collaborative care model (CCM) and was subsequently adjusted to align with the context of China. The second phase entails a pragmatic, two-arm, cluster randomized controlled implementation trial, accompanied by parallel mixed-methods process evaluation and cost-effectiveness analysis.

DISCUSSION

We anticipate CIC-PDD project will facilitate the development and innovation of PCIC model and related theories worldwide, particularly in low- and middle-income countries (LMICs). In addition, CIC-PDD project will contribute to the exploration of primary health care (PHC) in addressing the multimorbidity of physical and mental health issues.

TRIAL REGISTRATION

ClinicalTrials.gov registration ChiCTR2200065608 (China Clinical Trials Registry https://www.chictr.org.cn ). Registered on November 9, 2022.

摘要

背景

由于医疗保健提供系统碎片化,糖尿病和抑郁症的多重合并症管理对患者和医疗保健专业人员来说仍然是一个临床挑战。为了有效地应对多重合并症,全球迫切需要将卫生系统转变为以患者为中心的整合医疗(PCIC)系统。因此,本文介绍了基于社区的糖尿病和抑郁症患者整合护理(CIC-PDD)项目的方案,这是一个整合和共享护理干预项目。

方法/设计:CIC-PDD 项目分两个阶段进行,即“护理模式开发”和“实施和评估”。在第一阶段,根据协作护理模式(CCM)的四项标准设计和开发了 CIC-PDD 模式,随后进行了调整,以适应中国的国情。第二阶段包括一项实用的、两臂、集群随机对照实施试验,同时进行平行的混合方法过程评估和成本效益分析。

讨论

我们预计 CIC-PDD 项目将促进全球 PCIC 模式和相关理论的发展和创新,特别是在中低收入国家(LMICs)。此外,CIC-PDD 项目将有助于探索初级卫生保健(PHC)在解决身心健康多重合并症方面的作用。

试验注册

ClinicalTrials.gov 注册号 ChiCTR2200065608(中国临床试验注册中心 https://www.chictr.org.cn )。于 2022 年 11 月 9 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/68bd/10464429/a541457f1a4b/13063_2023_7561_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/68bd/10464429/1ab669ef68ea/13063_2023_7561_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/68bd/10464429/e3faf48181a8/13063_2023_7561_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/68bd/10464429/a541457f1a4b/13063_2023_7561_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/68bd/10464429/1ab669ef68ea/13063_2023_7561_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/68bd/10464429/e3faf48181a8/13063_2023_7561_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/68bd/10464429/a541457f1a4b/13063_2023_7561_Fig3_HTML.jpg

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