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一项针对在初级保健环境中增强非裔美国人的抑郁护理的标准质量改进与以患者为中心的干预措施的集群随机试验:研究方案 NCT00243425。

A cluster randomized trial of standard quality improvement versus patient-centered interventions to enhance depression care for African Americans in the primary care setting: study protocol NCT00243425.

机构信息

Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, USA.

出版信息

Implement Sci. 2010 Feb 23;5:18. doi: 10.1186/1748-5908-5-18.

DOI:10.1186/1748-5908-5-18
PMID:20178624
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2838803/
Abstract

BACKGROUND

Several studies document disparities in access to care and quality of care for depression for African Americans. Research suggests that patient attitudes and clinician communication behaviors may contribute to these disparities. Evidence links patient-centered care to improvements in mental health outcomes; therefore, quality improvement interventions that enhance this dimension of care are promising strategies to improve treatment and outcomes of depression among African Americans. This paper describes the design of the BRIDGE (Blacks Receiving Interventions for Depression and Gaining Empowerment) Study. The goal of the study is to compare the effectiveness of two interventions for African-American patients with depression--a standard quality improvement program and a patient-centered quality improvement program. The main hypothesis is that patients in the patient-centered group will have a greater reduction in their depression symptoms, higher rates of depression remission, and greater improvements in mental health functioning at six, twelve, and eighteen months than patients in the standard group. The study also examines patient ratings of care and receipt of guideline-concordant treatment for depression.

METHODS/DESIGN: A total of 36 primary care clinicians and 132 of their African-American patients with major depressive disorder were recruited into a cluster randomized trial. The study uses intent-to-treat analyses to compare the effectiveness of standard quality improvement interventions (academic detailing about depression guidelines for clinicians and disease-oriented care management for their patients) and patient-centered quality improvement interventions (communication skills training to enhance participatory decision-making for clinicians and care management focused on explanatory models, socio-cultural barriers, and treatment preferences for their patients) for improving outcomes over 12 months of follow-up.

DISCUSSION

The BRIDGE Study includes clinicians and African-American patients in under-resourced community-based practices who have not been well-represented in clinical trials to improve depression care. The patient-centered and culturally targeted approach to depression care is a relatively new one that has not been tested in most previous studies. The study will provide evidence about whether patient-centered accommodations improve quality of care and outcomes to a greater extent than standard quality improvement strategies for African Americans with depression.

TRIAL REGISTRATION

ClinicalTrials.gov NCT00243425.

摘要

背景

多项研究记录了非裔美国人在获得医疗服务和医疗服务质量方面存在差异。研究表明,患者态度和临床医生沟通行为可能导致了这些差异。有证据表明以患者为中心的护理与改善心理健康结果相关;因此,增强护理这一方面的质量改进干预措施是改善非裔美国人抑郁症治疗和结局的有前景的策略。本文描述了 BRIDGE(黑人接受抑郁干预和获得赋权)研究的设计。该研究的目标是比较两种干预措施对非裔美国抑郁症患者的效果——一种是标准质量改进方案,另一种是以患者为中心的质量改进方案。主要假设是,以患者为中心组的患者在六个月、十二个月和十八个月时,其抑郁症状会有更大程度的减轻、抑郁缓解率更高、心理健康功能改善更大,而标准组的患者则没有。该研究还检查了患者对护理的评价以及接受抑郁症指南一致治疗的情况。

方法/设计:共有 36 名初级保健临床医生和 132 名患有重度抑郁症的非裔美国患者被招募到一项聚类随机试验中。该研究采用意向治疗分析来比较标准质量改进干预措施(为临床医生提供关于抑郁指南的学术详细信息和针对患者的疾病导向护理管理)和以患者为中心的质量改进干预措施(增强临床医生参与式决策的沟通技巧培训和针对患者的解释模型、社会文化障碍和治疗偏好的护理管理)在 12 个月的随访中改善结果的效果。

讨论

BRIDGE 研究包括资源有限的社区实践中的临床医生和非裔美国患者,他们在改善抑郁症护理的临床试验中代表性不足。以患者为中心和文化针对性的抑郁症护理方法相对较新,在大多数先前的研究中尚未得到检验。该研究将提供证据,证明以患者为中心的适应措施是否在更大程度上改善了非裔美国人的护理质量和结果,而不是标准的质量改进策略。

试验注册

ClinicalTrials.gov NCT00243425。

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