Cargando…
Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study
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...
Autores principales: | , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6104790/ https://www.ncbi.nlm.nih.gov/pubmed/30121609 http://dx.doi.org/10.1136/bmjopen-2018-022317 |
_version_ | 1783349554587893760 |
---|---|
author | Salam, Abdul Webster, Ruth Patel, Anushka Godamunne, Pavithra Pathmeswaran, Arunasalam de Silva, H Asita Rogers, Anthony Jan, Stephen Laba, Tracey-Lea |
author_facet | Salam, Abdul Webster, Ruth Patel, Anushka Godamunne, Pavithra Pathmeswaran, Arunasalam de Silva, H Asita Rogers, Anthony Jan, Stephen Laba, Tracey-Lea |
author_sort | Salam, Abdul |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6104790 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-61047902018-08-24 Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study Salam, Abdul Webster, Ruth Patel, Anushka Godamunne, Pavithra Pathmeswaran, Arunasalam de Silva, H Asita Rogers, Anthony Jan, Stephen Laba, Tracey-Lea BMJ Open Qualitative Research 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. BMJ Publishing Group 2018-08-17 /pmc/articles/PMC6104790/ /pubmed/30121609 http://dx.doi.org/10.1136/bmjopen-2018-022317 Text en © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 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/. |
spellingShingle | Qualitative Research Salam, Abdul Webster, Ruth Patel, Anushka Godamunne, Pavithra Pathmeswaran, Arunasalam de Silva, H Asita Rogers, Anthony Jan, Stephen Laba, Tracey-Lea Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study |
title | Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study |
title_full | Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study |
title_fullStr | Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study |
title_full_unstemmed | Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study |
title_short | Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study |
title_sort | process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study |
topic | Qualitative Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6104790/ https://www.ncbi.nlm.nih.gov/pubmed/30121609 http://dx.doi.org/10.1136/bmjopen-2018-022317 |
work_keys_str_mv | AT salamabdul processevaluationofarandomisedcontrolledtrialofapharmacologicalstrategytoimprovehypertensioncontrolprotocolforaqualitativestudy AT websterruth processevaluationofarandomisedcontrolledtrialofapharmacologicalstrategytoimprovehypertensioncontrolprotocolforaqualitativestudy AT patelanushka processevaluationofarandomisedcontrolledtrialofapharmacologicalstrategytoimprovehypertensioncontrolprotocolforaqualitativestudy AT godamunnepavithra processevaluationofarandomisedcontrolledtrialofapharmacologicalstrategytoimprovehypertensioncontrolprotocolforaqualitativestudy AT pathmeswaranarunasalam processevaluationofarandomisedcontrolledtrialofapharmacologicalstrategytoimprovehypertensioncontrolprotocolforaqualitativestudy AT desilvahasita processevaluationofarandomisedcontrolledtrialofapharmacologicalstrategytoimprovehypertensioncontrolprotocolforaqualitativestudy AT rogersanthony processevaluationofarandomisedcontrolledtrialofapharmacologicalstrategytoimprovehypertensioncontrolprotocolforaqualitativestudy AT janstephen processevaluationofarandomisedcontrolledtrialofapharmacologicalstrategytoimprovehypertensioncontrolprotocolforaqualitativestudy AT labatraceylea processevaluationofarandomisedcontrolledtrialofapharmacologicalstrategytoimprovehypertensioncontrolprotocolforaqualitativestudy |