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

IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Abdul Salam, Tracey Laba, Rupasvi Dhurjati, Lakshmi K Josyula, Asita de Silva, Pavithra Godamunne, Rama Guggilla, Stephen Jan, Pallab Kumar Maulik, Nitish Naik, Anushka Patel, Arunasalam Pathmeswaran, Dorairaj Prabhakaran, Anthony Rodgers, Vanessa Selak, Ruth Webster Griffiths
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引用次数: 0

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.

三次低剂量联合用药策略改善高血压控制的随机试验过程评价:一项定性研究。
背景:高血压(BP)是一个重要的全球健康问题,许多接受治疗的患者未能达到血压控制。三联丸与轻中度高血压患者常规护理管理(TRIUMPH)试验评估了早期使用低剂量三联固定剂量降血压药物(“三联丸”)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试验显示,与常规护理相比,三联药策略的血压控制效果更好。对TRIUMPH试验的过程评估旨在探讨影响试验结果的背景因素、三丸战略的实施、其效果机制以及在常规实践中实施三丸战略的潜在障碍和促进因素。方法:在英国医学研究委员会框架的指导下,对参与TRIUMPH试验的23名患者和13名医疗保健提供者进行了半结构化访谈。采用NVivo框架分析法对数据进行分析。结果:斯里兰卡的高血压护理受到缺乏系统筛查和公共诊所人满为患的阻碍。尽管公立诊所提供免费药物,但漫长的等待时间和偶尔的缺货带来了挑战。在TRIUMPH试验中,干预和常规护理都是在“优于常规”护理的情况下提供的,包括以团队为基础的管理、减少等待时间、旅费资助、常规依从性监测和强化随访。三粒药策略提供了一个简化的治疗方案,更好地获得降压药物和更好的降压效果。在常规实践中实施的主要障碍包括三粒药丸的大尺寸,治疗惰性和关于固定剂量组合的限制性监管政策。结论:在常规实践中实施三联丸战略需要加强卫生系统,提供者培训和支持性政策措施,以复制其在试验中所见的有效性。试验注册号:ACTRN12612001120864, SLCTR/2015/020。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMJ Open
BMJ Open MEDICINE, GENERAL & INTERNAL-
CiteScore
4.40
自引率
3.40%
发文量
4510
审稿时长
2-3 weeks
期刊介绍: BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.
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