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

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 acceptabili...

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Main Authors: Vanessa Selak, Anushka Patel, Anthony Rodgers, Stephen Jan, Dorairaj Prabhakaran, Abdul Salam, Lakshmi K Josyula, Nitish Naik, Pavithra Godamunne, Arunasalam Pathmeswaran, Tracey Laba, Rupasvi Dhurjati, Asita de Silva, Pallab Kumar Maulik, Rama Guggilla, Ruth Webster (Griffiths)
Format: Article
Language:English
Published: BMJ Publishing Group 2025-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/6/e101689.full
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author Vanessa Selak
Anushka Patel
Anthony Rodgers
Stephen Jan
Dorairaj Prabhakaran
Abdul Salam
Lakshmi K Josyula
Nitish Naik
Pavithra Godamunne
Arunasalam Pathmeswaran
Tracey Laba
Rupasvi Dhurjati
Asita de Silva
Pallab Kumar Maulik
Rama Guggilla
Ruth Webster (Griffiths)
author_facet Vanessa Selak
Anushka Patel
Anthony Rodgers
Stephen Jan
Dorairaj Prabhakaran
Abdul Salam
Lakshmi K Josyula
Nitish Naik
Pavithra Godamunne
Arunasalam Pathmeswaran
Tracey Laba
Rupasvi Dhurjati
Asita de Silva
Pallab Kumar Maulik
Rama Guggilla
Ruth Webster (Griffiths)
author_sort Vanessa Selak
collection DOAJ
description 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.
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spelling doaj-art-4c47f1e0d9ba45b59a7ba57e7b7848d52025-06-28T03:25:11ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2025-101689Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative studyVanessa Selak0Anushka Patel1Anthony Rodgers2Stephen Jan3Dorairaj Prabhakaran4Abdul Salam5Lakshmi K Josyula6Nitish Naik7Pavithra Godamunne8Arunasalam Pathmeswaran9Tracey Laba10Rupasvi Dhurjati11Asita de Silva12Pallab Kumar Maulik13Rama Guggilla14Ruth Webster (Griffiths)15Epidemiology & Biostatistics, University of Auckland, Auckland, New ZealandUniversity of New South Wales, Sydney, New South Wales, AustraliaUniversity of New South Wales, Sydney, New South Wales, AustraliaUniversity of New South Wales, Sydney, New South Wales, AustraliaCentre for Chronic Disease Control, New Delhi, IndiaThe George Institute for Global Health India, New Delhi, IndiaIndian Institute of Public Health, Hyderabad, Telangana, IndiaAll India Institute of Medical Sciences, New Delhi, IndiaDepartment of Medical Education, Faculty of Medicine, University of Kelaniya, Colombo, Sri LankaDepartment of Public Health, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri LankaThe University of Sydney, Sydney, New South Wales, AustraliaThe George Institute for Global Health India, Telangana, Hyderabad, IndiaUniversity of Kelaniya Faculty of Medicine, Ragama, Western, Sri LankaThe George Institute for Global Health India, New Delhi, IndiaUppsala University, Uppsala, SwedenThe George Institute for Global Health, Sydney, New South Wales, AustraliaBackground 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.https://bmjopen.bmj.com/content/15/6/e101689.full
spellingShingle Vanessa Selak
Anushka Patel
Anthony Rodgers
Stephen Jan
Dorairaj Prabhakaran
Abdul Salam
Lakshmi K Josyula
Nitish Naik
Pavithra Godamunne
Arunasalam Pathmeswaran
Tracey Laba
Rupasvi Dhurjati
Asita de Silva
Pallab Kumar Maulik
Rama Guggilla
Ruth Webster (Griffiths)
Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative study
BMJ Open
title Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative study
title_full Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative study
title_fullStr Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative study
title_full_unstemmed Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative study
title_short Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative study
title_sort process evaluation of a randomised trial of a triple low dose combination pill strategy to improve hypertension control a qualitative study
url https://bmjopen.bmj.com/content/15/6/e101689.full
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