基层医疗中的移动糖尿病教育团队（MDETs）是否能改善患者的护理流程和健康结局？一项随机对照试验的研究方案。

Will Mobile Diabetes Education Teams (MDETs) in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial.

机构信息

Ryerson University, School of Nutrition, 350 Victoria Street, Toronto, ON M5B 2 K3, Canada.

出版信息

Trials. 2012 Sep 13;13:165. doi: 10.1186/1745-6215-13-165.

DOI:10.1186/1745-6215-13-165

PMID:22974080

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3519552/

Abstract

BACKGROUND

There is evidence to suggest that delivery of diabetes self-management support by diabetes educators in primary care may improve patient care processes and patient clinical outcomes; however, the evaluation of such a model in primary care is nonexistent in Canada. This article describes the design for the evaluation of the implementation of Mobile Diabetes Education Teams (MDETs) in primary care settings in Canada.

METHODS/DESIGN: This study will use a non-blinded, cluster-randomized controlled trial stepped wedge design to evaluate the Mobile Diabetes Education Teams' intervention in improving patient clinical and care process outcomes. A total of 1,200 patient charts at participating primary care sites will be reviewed for data extraction. Eligible patients will be those aged ≥18, who have type 2 diabetes and a hemoglobin A1c (HbA1c) of ≥8%. Clusters (that is, primary care sites) will be randomized to the intervention and control group using a block randomization procedure within practice size as the blocking factor. A stepped wedge design will be used to sequentially roll out the intervention so that all clusters eventually receive the intervention. The time at which each cluster begins the intervention is randomized to one of the four roll out periods (0, 6, 12, and 18 months). Clusters that are randomized into the intervention later will act as the control for those receiving the intervention earlier. The primary outcome measure will be the difference in the proportion of patients who achieve the recommended HbA1c target of ≤7% between intervention and control groups. Qualitative work (in-depth interviews with primary care physicians, MDET educators and patients; and MDET educators' field notes and debriefing sessions) will be undertaken to assess the implementation process and effectiveness of the MDET intervention.

TRIAL REGISTRATION

ClinicalTrials.gov NCT01553266.

摘要

背景

有证据表明，在初级保健中由糖尿病教育者提供糖尿病自我管理支持可能会改善患者的护理过程和临床结果；然而，在加拿大，这种模式在初级保健中的评估尚属空白。本文介绍了在加拿大初级保健环境中评估移动糖尿病教育团队（MDET）实施情况的设计。

方法/设计：本研究将采用非盲、集群随机对照试验阶梯式楔形设计来评估移动糖尿病教育团队干预对改善患者临床和护理过程结果的影响。将对参与初级保健场所的 1200 份患者病历进行数据提取审查。合格患者为年龄≥18 岁、患有 2 型糖尿病且糖化血红蛋白（HbA1c）≥8%的患者。使用实践规模作为分层因素的块随机分组程序对集群（即初级保健场所）进行随机分组，将其分为干预组和对照组。采用阶梯式楔形设计逐步推出干预措施，以使所有集群最终都能接受干预。每个集群开始干预的时间随机分配到四个推出期（0、6、12 和 18 个月）之一。随机分配到干预组较晚的集群将作为较早接受干预的对照组。主要结局指标是干预组和对照组之间达到推荐的 HbA1c 目标（≤7%）的患者比例差异。将进行定性工作（对初级保健医生、MDET 教育者和患者进行深入访谈；以及 MDET 教育者的实地记录和汇报会议），以评估 MDET 干预的实施过程和效果。