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糖尿病合并抑郁患者协作式初级保健团队模式的对照试验:全面评估的原理和设计。

Controlled trial of a collaborative primary care team model for patients with diabetes and depression: rationale and design for a comprehensive evaluation.

机构信息

Department of Public Health Sciences, University of Alberta, Edmonton, Canada.

出版信息

BMC Health Serv Res. 2012 Aug 16;12:258. doi: 10.1186/1472-6963-12-258.

DOI:10.1186/1472-6963-12-258
PMID:22897901
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3445824/
Abstract

BACKGROUND

When depression accompanies diabetes, it complicates treatment, portends worse outcomes and increases health care costs. A collaborative care case-management model, previously tested in an urban managed care organization in the US, achieved significant reduction of depressive symptoms, improved diabetes disease control and patient-reported outcomes, and saved money. While impressive, these findings need to be replicated and extended to other healthcare settings. Our objective is to comprehensively evaluate a collaborative care model for comorbid depression and type 2 diabetes within a Canadian primary care setting.

METHODS/DESIGN: We initiated the TeamCare model in four Primary Care Networks in Northern Alberta. The intervention involves a nurse care manager guiding patient-centered care with family physicians and consultant physician specialists to monitor progress and develop tailored care plans. Patients eligible for the intervention will be identified using the Patient Health Questionnaire-9 as a screen for depressive symptoms. Care managers will then guide patients through three phases: 1) improving depressive symptoms, 2) improving blood glucose, blood pressure and cholesterol, and 3) improving lifestyle behaviors. We will employ the RE-AIM framework for a comprehensive and mixed-methods approach to our evaluation. Effectiveness will be assessed using a controlled "on-off" trial design, whereby eligible patients would be alternately enrolled in the TeamCare intervention or usual care on a monthly basis. All patients will be assessed at baseline, 6 and 12 months. Our primary analyses will be based on changes in two outcomes: depressive symptoms, and a multivariable, scaled marginal model for the combined outcome of global disease control (i.e., A1c, systolic blood pressure, LDL cholesterol). Our planned enrolment of 168 patients will provide greater than 80% power to observe clinically important improvements in all measured outcomes. Direct costing of all intervention components and measurement of all health care utilization using linked administrative databases will be used to determine the cost-effectiveness of the intervention relative to usual care.

DISCUSSION

Our comprehensive evaluation will generate evidence to reliability, effectiveness and sustainability of this collaborative care model for patients with chronic diseases and depression.

TRIALS REGISTRATION

Clinicaltrials.gov Identifier: NCT01328639.

摘要

背景

当抑郁症伴随糖尿病时,它会使治疗变得复杂,预示着更糟糕的结果,并增加医疗保健成本。一种协作式护理病例管理模式,之前在美国的一家城市管理式医疗组织中进行了测试,实现了抑郁症状的显著减轻、糖尿病疾病控制和患者报告结果的改善,并且节省了资金。虽然令人印象深刻,但这些发现需要在其他医疗保健环境中复制和扩展。我们的目标是在加拿大的一个初级保健环境中全面评估一种针对共病抑郁症和 2 型糖尿病的协作式护理模式。

方法/设计:我们在阿尔伯塔省北部的四个初级保健网络中启动了 TeamCare 模式。该干预措施涉及一名护士护理经理,指导以家庭医生和顾问医生专家为中心的患者护理,以监测进展并制定量身定制的护理计划。将使用患者健康问卷-9 作为抑郁症状的筛查工具来确定有资格接受干预的患者。然后,护理经理将指导患者完成三个阶段:1)改善抑郁症状,2)改善血糖、血压和胆固醇,3)改善生活方式行为。我们将采用 RE-AIM 框架对我们的评估进行全面和混合方法的方法。使用“开-关”试验设计评估有效性,即符合条件的患者将每月交替接受 TeamCare 干预或常规护理。所有患者将在基线、6 个月和 12 个月进行评估。我们的主要分析将基于两个结果的变化:抑郁症状和一个多变量、比例边际模型,用于衡量全球疾病控制的综合结果(即 A1c、收缩压、LDL 胆固醇)。我们计划招募的 168 名患者将提供超过 80%的效力来观察所有测量结果的临床重要改善。通过链接的行政数据库对所有干预措施的成本和所有医疗保健利用的测量,将确定与常规护理相比,干预措施的成本效益。

讨论

我们的综合评估将为这种针对患有慢性疾病和抑郁症的患者的协作式护理模式的可靠性、有效性和可持续性提供证据。

试验注册

Clinicaltrials.gov 标识符:NCT01328639。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a882/3445824/dd93d7751511/1472-6963-12-258-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a882/3445824/ac22e6d7593a/1472-6963-12-258-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a882/3445824/dd93d7751511/1472-6963-12-258-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a882/3445824/ac22e6d7593a/1472-6963-12-258-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a882/3445824/dd93d7751511/1472-6963-12-258-2.jpg

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