健康之锦 Ontario：一项多地点随机对照试验，旨在检验实施和再现性。

Health TAPESTRY Ontario: A Multi-Site Randomized Controlled Trial Testing Implementation and Reproducibility.

机构信息

Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada (D. M., L. L., D. O., S. B., T. C., R. C., J. D., L. D., J. G., P. F., M. H., C. R., D. P.)

Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada (D. M., L. L., D. O., S. B., T. C., R. C., J. D., L. D., J. G., P. F., M. H., C. R., D. P.).

出版信息

Ann Fam Med. 2023 Mar-Apr;21(2):132-142. doi: 10.1370/afm.2944.

DOI:10.1370/afm.2944

PMID:36973055

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10042555/

Abstract

PURPOSE

Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a complex primary care program aimed at assisting older adults to stay healthier for longer. This study evaluated the feasibility of implementation across multiple sites, and the reproducibility of the effects found in the previous randomized controlled trial.

METHODS

This was a pragmatic, unblinded, 6-month parallel group randomized controlled trial. Participants were randomized (intervention or control) using a computer-generated system. Eligible patients, aged 70 years and older, were rostered to 1 of 6 participating interprofessional primary care practices (urban and rural). In total, 599 (301 intervention, 298 control) patients were recruited from March 2018 through August 2019. Intervention participants received a home visit from volunteers to collect information on physical and mental health, and social context. An interprofessional care team created and implemented a plan of care. The primary outcomes were physical activity and number of hospitalizations.

RESULTS

Based on the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, Health TAPESTRY had widespread reach and adoption. In the intention-to-treat analysis (257 intervention, 255 control), there were no statistically significant between-group differences for hospitalizations (incidence rate ratio = 0.79; 95% CI, 0.48-1.30; = .35) or total physical activity (mean difference = -0.26; 95% CI, -1.18 to 0.67; = .58). There were 37 non-study related serious adverse events (19 intervention, 18 control).

CONCLUSIONS

We found Health TAPESTRY was successfully implemented for patients in diverse primary care practices; however, implementation did not reproduce the effect on hospitalizations and physical activity found in the initial randomized controlled trial.

摘要

目的

推进患者体验的医疗团队：增强质量（Health TAPESTRY）是一项复杂的初级保健计划，旨在帮助老年人更长久地保持健康。本研究评估了在多个地点实施的可行性，以及在之前的随机对照试验中发现的效果的重现性。

方法

这是一项实用的、非盲的、6 个月的平行组随机对照试验。参与者使用计算机生成的系统进行随机（干预或对照）分组。符合条件的患者年龄在 70 岁及以上，被分配到 6 个参与的跨专业初级保健实践（城市和农村）之一。共有 599 名（301 名干预组，298 名对照组）患者于 2018 年 3 月至 2019 年 8 月入选。干预组参与者接受志愿者的家访，以收集身体和心理健康以及社会背景的信息。一个跨专业的护理团队制定并实施了护理计划。主要结局是身体活动和住院次数。

结果

根据 Reach、Effectiveness、Adoption、Implementation、Maintenance（RE-AIM）框架，Health TAPESTRY 具有广泛的覆盖范围和采用率。在意向治疗分析（257 名干预组，255 名对照组）中，组间住院率（发生率比=0.79；95%置信区间，0.48-1.30；=0.35）或总身体活动（平均差异=-0.26；95%置信区间，-1.18 至 0.67；=0.58）无统计学显著差异。有 37 例非研究相关的严重不良事件（19 例干预组，18 例对照组）。