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      Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study

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          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.

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          Most cited references9

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          2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American college of cardiology/American heart association task force on clinical practice guidelines

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            The costs of interrupting antihypertensive drug therapy in a Medicaid population.

            This research explores the association between the interruption or termination of antihypertensive drug therapy and total health care costs among non-institutionalized Medicaid patients older than age 40 who survive the first year after treatment. Multivariate regression analysis was used to estimate the statistical relationship between post-treatment costs and patient demographic characteristics, prior use of services, the type of medication used as initial therapy and whether the patient maintained continuous therapy. Paid claims data from the California Medicaid (Medi-Cal) program were used in the analysis. Total cost of health care in the first year after the initiation of drug therapy was the primary outcome variable. Components of total costs (e.g., hospital, outpatient and physician services, prescription drugs) were also investigated. Nearly 86% of new antihypertensive drug therapy patients interrupted or discontinued purchasing any form of antihypertensive medication during the first year. Patients with interrupted antihypertensive drug therapy consumed an additional $873 per patient (P < .0001) in health care during the first year, not counting a reduction in prescription drug cost of $281 (P < .0001). Increased costs were primarily due to increased hospital expenditures of $637 (P < .0002).
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              The direct costs to the NHS of discontinuing and switching prescriptions for hypertension.

              There is much evidence to suggest that the treatment of hypertension reduces the risk of cardiovascular diseases and that it is cost-effective in most patients. However, the effectiveness of treatment relies on compliance and maintenance of treatment. Each pharmacological agent differs in terms of side effects. The existence of side effects can result in poor compliance and switching between treatments. A number of studies have reported high discontinuation rates for anti-hypertensive therapies. This potentially imposes costs on the health service. The aim of this study is to use the MEDIPLUS data set to consider the cost arising from switching and discontinuation of therapy. The analysis will assess the resource costs in terms of extra GP visits and hospitalisations arising from individuals switching and discontinuing treatments. The total costs of hypertension were estimated to be around 76.5 m pound sterling per annum, of which 26.9 m pound sterling can be attributed to patients who switch or discontinue therapy.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2018
                17 August 2018
                : 8
                : 8
                : e022317
                Affiliations
                [1 ] departmentThe George Institute for Global Health , University of New South Wales , Hyderabad, India
                [2 ] departmentThe George Institute for Global Health , University of New South Wales , Sydney, Australia
                [3 ] departmentDepartment of Medical Education, Faculty of Medicine , University of Kelaniya , Kelaniya, Sri Lanka
                [4 ] departmentDepartment of Public Health, Faculty of Medicine , University of Kelaniya , Kelaniya, Sri Lanka
                [5 ] departmentClinical Trials Unit, Department of Pharmacology, Faculty of Medicine , University of Kelaniya , Kelaniya, Sri Lanka
                [6 ] departmentMenzies Centre for Health Policy, Sydney Medical School , The University of Sydney , Camperdown, New South Wales, Australia
                Author notes
                [Correspondence to ] Dr Abdul Salam; asalam@ 123456georgeinstitute.org.in
                Author information
                http://orcid.org/0000-0002-5870-7936
                http://orcid.org/0000-0002-5182-9092
                Article
                bmjopen-2018-022317
                10.1136/bmjopen-2018-022317
                6104790
                30121609
                159e5d61-f284-43be-b7ab-879a56677af3
                © 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/.

                History
                : 14 February 2018
                : 10 July 2018
                : 13 July 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000925, National Health and Medical Research Council;
                Categories
                Qualitative Research
                Protocol
                1506
                1725
                Custom metadata
                unlocked

                Medicine
                process evaluation,combination therapy,bp lowering drugs,hypertension control
                Medicine
                process evaluation, combination therapy, bp lowering drugs, hypertension control

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