INterpreting the Processes of the UMPIRE Trial (INPUT): Protocol for a qualitative process evaluation study of a fixed-dose combination (FDC) strategy to improve adherence to cardiovascular medications

Salam, A; Stewart, F; Singh, K; Thom, S; Williams, HJ; Patel, A; Jan, S; Laba, T; Prabhakaran, D; Maulik, P; Day, S; Ward, H

INterpreting the Processes of the UMPIRE Trial (INPUT): Protocol for a qualitative process evaluation study of a fixed-dose combination (FDC) strategy to improve adherence to cardiovascular medications

Salam, A Stewart, F Singh, K Thom, S Williams, HJ Patel, A Jan, S Laba, T

Prabhakaran, D Maulik, P Day, S Ward, H

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Publication Type:: Journal Article
Citation:: BMJ Open, 2013, 3 (5)
Issue Date:: 2013-06-06

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Field	Value	Language
dc.contributor.author	Salam, A	en_US
dc.contributor.author	Stewart, F	en_US
dc.contributor.author	Singh, K	en_US
dc.contributor.author	Thom, S	en_US
dc.contributor.author	Williams, HJ	en_US
dc.contributor.author	Patel, A	en_US
dc.contributor.author	Jan, S	en_US
dc.contributor.author	Laba, T https://orcid.org/0000-0002-5182-9092	en_US
dc.contributor.author	Prabhakaran, D	en_US
dc.contributor.author	Maulik, P	en_US
dc.contributor.author	Day, S	en_US
dc.contributor.author	Ward, H	en_US
dc.date.issued	2013-06-06	en_US
dc.identifier.citation	BMJ Open, 2013, 3 (5)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/135166
dc.description.abstract	Introduction: This paper describes a planned process evaluation of the Use of a Multidrug Pill In Reducing Cardiovascular Events (UMPIRE) trial, one of several randomised clinical trials taking place globally to assess the potential of cardiovascular drugs as a fixeddose combination ( polypill) in cardiovascular disease prevention. A fixed-dose combination may be a promising strategy for promoting adherence to medication; alleviating pill burden through simplifying regimens and reducing cost. This process evaluation will complement the UMPIRE trial by using qualitative research methods to inform understanding of the complex interplay of factors that underpin trial outcomes. Methods: A series of semistructured, in-depth interviews with local health professionals and UMPIRE trial participants in India and the UK will be undertaken. The aim is to understand their views and experiences of the trial context and of day-to-day use of medications more generally. The grounded theory approach will be used to analyse data and help inform the processes of the UMPIRE trial. Ethics and dissemination: The study has received ethical approval for all sites in the UK and India where trial participant interviews will be undertaken. The process evaluation will help inform and enhance the understanding of the UMPIRE trial results and its applicability to clinical practice as well as shaping policy regarding strategies for improving cardiovascular medication adherence.	en_US
dc.relation.ispartof	BMJ Open	en_US
dc.relation.isbasedon	10.1136/bmjopen-2012-002313	en_US
dc.title	INterpreting the Processes of the UMPIRE Trial (INPUT): Protocol for a qualitative process evaluation study of a fixed-dose combination (FDC) strategy to improve adherence to cardiovascular medications	en_US
dc.type	Journal Article
utslib.citation.volume	5	en_US
utslib.citation.volume	3	en_US
utslib.for	1103 Clinical Sciences	en_US
utslib.for	1117 Public Health and Health Services	en_US
utslib.for	1199 Other Medical and Health Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Business
pubs.organisational-group	/University of Technology Sydney/Strength - CHERE - Centre for Health Economics Research and Evaluation
utslib.copyright.status	open_access
pubs.issue	5	en_US
pubs.publication-status	Published	en_US
pubs.volume	3	en_US

Abstract:

Introduction: This paper describes a planned process evaluation of the Use of a Multidrug Pill In Reducing Cardiovascular Events (UMPIRE) trial, one of several randomised clinical trials taking place globally to assess the potential of cardiovascular drugs as a fixeddose combination ( polypill) in cardiovascular disease prevention. A fixed-dose combination may be a promising strategy for promoting adherence to medication; alleviating pill burden through simplifying regimens and reducing cost. This process evaluation will complement the UMPIRE trial by using qualitative research methods to inform understanding of the complex interplay of factors that underpin trial outcomes. Methods: A series of semistructured, in-depth interviews with local health professionals and UMPIRE trial participants in India and the UK will be undertaken. The aim is to understand their views and experiences of the trial context and of day-to-day use of medications more generally. The grounded theory approach will be used to analyse data and help inform the processes of the UMPIRE trial. Ethics and dissemination: The study has received ethical approval for all sites in the UK and India where trial participant interviews will be undertaken. The process evaluation will help inform and enhance the understanding of the UMPIRE trial results and its applicability to clinical practice as well as shaping policy regarding strategies for improving cardiovascular medication adherence.

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http://hdl.handle.net/10453/135166