Salam Abdul, Webster Ruth, Patel Anushka, Godamunne Pavithra, Pathmeswaran Arunasalam, de Silva H Asita, Rogers Anthony, Jan Stephen, Laba Tracey-Lea
The George Institute for Global Health, University of New South Wales, Hyderabad, India.
The George Institute for Global Health, University of New South Wales, Sydney, Australia.
BMJ Open. 2018 Aug 17;8(8):e022317. doi: 10.1136/bmjopen-2018-022317.
Globally, the prevalence of uncontrolled hypertension is high, particularly in low- and middle-income countries. There is a critical need for strategies to improve hypertension control. The early use of a fixed low-dose combination of three antihypertensive drugs (triple pill) has the potential to significantly improve hypertension control. The ple Pill vs. sual care anagement for atients with mild-to- moderate ypertension (TRIUMPH) randomised controlled trial (RCT) is designed to test the effects of this strategy compared with usual care in patients with mild-to-moderate hypertension. This paper reports the protocol of a process evaluation of the TRIUMPH RCT. The objectives are to understand factors related to implementation of the intervention, mechanisms of effect, contextual factors that underpin the effectiveness of the triple pill strategy and the potential barriers and facilitators to implementing the strategy in clinical practice.
Face-to-face semistructured in-depth interviews with a purposive sample of TRIUMPH RCT participants and healthcare professionals in Sri Lanka will be conducted. Healthcare professionals will include physicians and their staff who were involved in conducting the TRIUMPH RCT. Interviewees will be recruited sequentially until thematic saturation is achieved. Interviews will be audio recorded, transcribed verbatim and analysed in NVivo using framework analysis methods.
The TRIUMPH RCT and process evaluation have received approval from the relevant Ethics Review Committee. All participants will be asked to provide written consent before participation. Findings from the study will be disseminated through publications and conference presentations.
ACTRN12612001120864 , SLCTR/2015/020 ; Pre-results.
在全球范围内，未得到控制的高血压患病率很高，尤其是在低收入和中等收入国家。迫切需要改善高血压控制的策略。早期使用三种抗高血压药物的固定低剂量组合（三联 pill）有可能显著改善高血压控制。轻度至中度高血压患者三联 pill 与常规护理管理比较（TRIUMPH）随机对照试验（RCT）旨在测试与常规护理相比该策略对轻度至中度高血压患者的效果。本文报告了 TRIUMPH RCT 过程评估的方案。目的是了解与干预实施相关的因素、作用机制、支持三联 pill 策略有效性的背景因素以及在临床实践中实施该策略的潜在障碍和促进因素。
将对 TRIUMPH RCT 的参与者以及斯里兰卡的医疗保健专业人员进行有目的抽样的面对面半结构化深入访谈。医疗保健专业人员将包括参与 TRIUMPH RCT 的医生及其工作人员。将依次招募受访者，直至达到主题饱和。访谈将进行录音，逐字转录，并在 NVivo 中使用框架分析方法进行分析。
TRIUMPH RCT 和过程评估已获得相关伦理审查委员会的批准。所有参与者在参与前都将被要求提供书面同意。该研究的结果将通过出版物和会议报告进行传播。
ACTRN12612001120864，SLCTR/2015/020；预结果。
