通过教育和辅导控制肾脏病中的高血压（CHECK-D）：一项群组随机对照试验的方案。

Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial.

机构信息

Department of Internal Medicine, Division of Nephrology, University of Michigan, Ann Arbor, Michigan, USA

Department of Internal Medicine, Quality & Innovation, University of Michigan, Ann Arbor, Michigan, USA.

出版信息

BMJ Open. 2023 Aug 1;13(8):e071318. doi: 10.1136/bmjopen-2022-071318.

DOI:10.1136/bmjopen-2022-071318

PMID:37527897

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10394555/

Abstract

INTRODUCTION

Chronic kidney disease (CKD) affects 30 million Americans. Early management focused on blood pressure (BP) control decreases cardiovascular morbidity and mortality. Less than 40% of patients with CKD achieve recommended BP targets due to many barriers. These barriers include a lack of understanding of the implications of their diagnosis and how to optimise their health.This cluster randomised control trial hypothesises that the combination of early primary care CKD education, and motivational interviewing (MI)-based health coach support, will improve patient behaviours aligned with BP control by increasing patient knowledge, self-efficacy and motivation. The results will aid in sustainable interventions for future patient-centric education and coaching support to improve quality and outcomes in patients with CKD stages 3-5. Outcomes in patients with CKD stages 3-5 receiving the intervention will be compared with similar patients within a control group. Continuous quality improvement (CQI) and systems methodologies will be used to optimise resource neutrality and leverage existing technology to support implementation and future dissemination. The innovative approach of this research focuses on the importance of a multidisciplinary team, including off-site patient coaching, that can intervene early in the CKD care continuum by supporting patients with education and coaching.

METHODS AND ANALYSIS

We will test impact of BP control when clinician-delivered education is followed by 12 months of MI-based health coaching. We will compare outcomes in 350 patients with CKD stages 3-5 between intervention and control groups in primary care. CQI and systems methodologies will optimise education and coaching for future implementation and dissemination.

ETHICS AND DISSEMINATION

This study was approved by the University of Michigan Institutional Review Boards (IRBMED) HUM00136011, HUM00150672 and SITE00000092 and the results of the study will be published on ClinicalTrials.gov, in peer-reviewed journals, as well as conference abstracts, posters and presentations.

TRIAL REGISTRATION NUMBER

NCT04087798.

摘要

简介

慢性肾脏病（CKD）影响了 3000 万美国人。早期以控制血压（BP）为重点的管理可降低心血管发病率和死亡率。由于存在多种障碍，只有不到 40%的 CKD 患者能够达到推荐的 BP 目标。这些障碍包括对其诊断的影响以及如何优化健康状况缺乏了解。这项随机对照试验假设，早期初级保健 CKD 教育与基于动机访谈（MI）的健康教练支持相结合，通过提高患者知识、自我效能感和动机，将改善与 BP 控制一致的患者行为。结果将有助于为未来以患者为中心的教育和教练支持提供可持续干预措施，以改善 CKD 3-5 期患者的质量和结局。与对照组中具有相似特征的患者相比，接受干预的 CKD 3-5 期患者的结局将进行比较。将使用持续质量改进（CQI）和系统方法来优化资源中立性，并利用现有技术支持实施和未来的传播。这项研究的创新方法侧重于多学科团队的重要性，包括远程患者教练，该团队可以通过教育和教练支持在 CKD 护理连续体早期介入，为患者提供支持。