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Qualitative research
Protocol
Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study
  1. Abdul Salam1,
  2. Ruth Webster2,
  3. Anushka Patel2,
  4. Pavithra Godamunne3,
  5. Arunasalam Pathmeswaran4,
  6. H Asita de Silva5,
  7. Anthony Rogers2,
  8. Stephen Jan2,
  9. Tracey-Lea Laba6
  1. 1 The George Institute for Global Health, University of New South Wales, Hyderabad, India
  2. 2 The George Institute for Global Health, University of New South Wales, Sydney, Australia
  3. 3 Department of Medical Education, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka
  4. 4 Department of Public Health, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka
  5. 5 Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka
  6. 6 Menzies Centre for Health Policy, Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia
  1. Correspondence to Dr Abdul Salam; asalam{at}georgeinstitute.org.in

Abstract

Introduction 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 TRI ple Pill vs. U sual care M anagement for P atients with mild-to- moderate H 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.

Methods and analysis 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.

Ethics and dissemination 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.

Trial registration number ACTRN12612001120864 , SLCTR/2015/020 ; Pre-results.

  • process evaluation
  • combination therapy
  • Bp lowering drugs
  • hypertension control

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-022317

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    Footnotes

    • Contributors AS, T-LL, RW, AP, AR, SJ: conceived and designed the study. PG, APS, HAdeS: contributed to the design of the study and are responsible for study coordination. AS, T-LL: drafted the manuscript. All authors reviewed the article and provided approval for the final version of the manuscript submitted to the journal for publication.

    • Funding This study is funded by the National Health and Medical Research Council (NHMRC) Australia, (App: 1041052) through The Global Alliance for Chronic Diseases (GACD) Hypertension prevention and control, funding scheme.

    • Competing interests George Health Enterprises, the social enterprise arm of The George Institute for Global Health, has received investment to develop fixed-dose combination products containing aspirin, statin and blood pressure lowering drugs. George Health Enterprises has submitted patents for low-dose blood pressure combinations, on which AR is listed as one of the inventors.

    • Patient consent Not required.

    • Ethics approval Ethics Review Committee, Faculty of Medicine, University of Kelaniya, Sri Lanka, and Ethics Review Committee (RPAH Zone), Sydney, Australia.

    • Provenance and peer review Not commissioned; externally peer reviewed.