一项旨在改善高血压控制的三低剂量复方药丸策略随机试验的过程评估：一项定性研究

Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative study.

作者信息

Salam Abdul, Laba Tracey, Dhurjati Rupasvi, Josyula Lakshmi K, de Silva Asita, Godamunne Pavithra, Guggilla Rama, Jan Stephen, Maulik Pallab Kumar, Naik Nitish, Patel Anushka, Pathmeswaran Arunasalam, Prabhakaran Dorairaj, Rodgers Anthony, Selak Vanessa, Webster Griffiths Ruth

机构信息

The George Institute for Global Health India, New Delhi, India

University of New South Wales, Sydney, New South Wales, Australia.

出版信息

BMJ Open. 2025 Jun 27;15(6):e101689. doi: 10.1136/bmjopen-2025-101689.

DOI:10.1136/bmjopen-2025-101689

PMID:40578894

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12207132/

Abstract

BACKGROUND

High blood pressure (BP) is a significant global health issue, with many treated patients failing to achieve BP control. The Triple Pill vs Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial evaluated the effectiveness, cost-effectiveness and acceptability of early use of low-dose triple fixed-dose combination of BP-lowering drugs ('triple pill') compared with usual care in the management of hypertension. The TRIUMPH trial showed superior BP control with the triple pill strategy compared with usual care. This process evaluation of the TRIUMPH trial aimed to explore the contextual factors that influenced the trial outcomes, implementation of the triple pill strategy, mechanisms of its effects and potential barriers and facilitators for implementing the triple pill strategy in routine practice.

METHODS

Guided by the UK Medical Research Council's framework, semistructured interviews were conducted with 23 patients and 13 healthcare providers involved in the TRIUMPH trial. Data were analysed using the framework analysis method in NVivo.

RESULTS

Hypertension care in Sri Lanka was hindered by the absence of systematic screening and overcrowded public clinics. Despite free medication provision at public clinics, long waiting times and occasional stock-outs posed challenges. In the TRIUMPH trial, both intervention and usual care were delivered in the context of 'better than usual' care, including team-based management, reduced waiting times, monetary assistance for travel, routine adherence monitoring and intensive follow-up. The triple pill strategy provided a simplified regimen, better access to BP-lowering medications and better BP-lowering efficacy. Key barriers to implementation in routine practice included the triple pill's large size, therapeutic inertia and restrictive regulatory policies regarding fixed-dose combinations.

CONCLUSIONS

Implementation of the triple pill strategy into routine practice requires health system strengthening, provider training and supportive policy measures to replicate its effectiveness seen in the trial.

TRIAL REGISTRATION NUMBER

ACTRN12612001120864, SLCTR/2015/020.

摘要

背景

高血压是一个重大的全球健康问题，许多接受治疗的患者未能实现血压控制。轻度至中度高血压患者的三联 pill 与常规护理管理（TRIUMPH）试验评估了早期使用低剂量降压药物三联固定剂量组合（“三联 pill”）与常规护理相比在高血压管理中的有效性、成本效益和可接受性。TRIUMPH 试验表明，与常规护理相比，三联 pill 策略能更好地控制血压。这项对 TRIUMPH 试验的过程评估旨在探讨影响试验结果的背景因素、三联 pill 策略的实施情况、其作用机制以及在常规实践中实施三联 pill 策略的潜在障碍和促进因素。

方法

在英国医学研究理事会的框架指导下，对参与 TRIUMPH 试验的 23 名患者和 13 名医疗服务提供者进行了半结构化访谈。使用 NVivo 中的框架分析方法对数据进行分析。

结果

斯里兰卡的高血压护理因缺乏系统筛查和公共诊所过度拥挤而受到阻碍。尽管公共诊所提供免费药物，但长时间等待和偶尔的药品短缺带来了挑战。在 TRIUMPH 试验中，干预措施和常规护理都是在“优于常规”的护理背景下进行的，包括基于团队的管理、缩短等待时间、提供交通费用补贴、常规依从性监测和强化随访。三联 pill 策略提供了一种简化的治疗方案，能更好地获取降压药物，且降压效果更好。在常规实践中实施的主要障碍包括三联 pill 尺寸较大、治疗惰性以及关于固定剂量组合的限制性监管政策。