Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease
Introduction It is important to ascertain the cost-effectiveness of alternative services to traditional cardiac rehabilitation while the economic credentials of the Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) programme among people with coronary heart disease (CHD) are unknow...
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BMJ Publishing Group
2020-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/8/e038178.full |
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| author | Clara Chow John Amerena Marj Moodie Kylie Ball Brian Oldenburg Jonathan Rawstorn Sarah McNaughton Karen Lamb Voltaire Nadurata Christopher Neil Stuart Cameron |
| author_facet | Clara Chow John Amerena Marj Moodie Kylie Ball Brian Oldenburg Jonathan Rawstorn Sarah McNaughton Karen Lamb Voltaire Nadurata Christopher Neil Stuart Cameron |
| author_sort | Clara Chow |
| collection | DOAJ |
| description | Introduction It is important to ascertain the cost-effectiveness of alternative services to traditional cardiac rehabilitation while the economic credentials of the Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) programme among people with coronary heart disease (CHD) are unknown. This economic protocol outlines the methods for undertaking a trial-based economic evaluation of SCRAM in the real-world setting in Australia.Methods and analysis The within-trial economic evaluation will be undertaken alongside a randomised controlled trial (RCT) designed to determine the effectiveness of SCRAM in comparison with the usual care cardiac rehabilitation (UC) alone in people with CHD. Pathway analysis will be performed to identify all the costs related to the delivery of SCRAM and UC. Both a healthcare system and a limited societal perspective will be adopted to gauge all costs associated with health resource utilisation and productivity loss. Healthcare resource use over the 6-month participation period will be extracted from administrative databases (ie, Pharmaceutical Benefits Scheme and Medical Benefits Schedule). Productivity loss will be measured by absenteeism from work (valued by human capital approach). The primary outcomes for the economic evaluation are maximal oxygen uptake (VO2max, mL/kg/min, primary RCT outcome) and quality-adjusted life years estimated from health-related quality of life as assessed by the Assessment of Quality of Life-8D instrument. The incremental cost-effectiveness ratio will be calculated using the differences in costs and benefits (ie, primary and secondary outcomes) between the two randomised groups from both perspectives with no discounting. All costs will be valued in Australian dollars for year 2020.Ethics and dissemination The study protocol has been approved under Australia’s National Mutual Acceptance agreement by the Melbourne Health Human Research Ethics Committee (HREC/18/MH/119). It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia. The evaluation will provide evidence to underpin national scale-up of the programme to a wider population. The results of the economic analysis will be submitted for publication in a peer-reviewed journal.Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12618001458224). |
| format | Article |
| id | doaj-art-052e1bbdb34646d49a9e636ddbde3a41 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-052e1bbdb34646d49a9e636ddbde3a412025-08-20T02:38:26ZengBMJ Publishing GroupBMJ Open2044-60552020-08-0110810.1136/bmjopen-2020-038178Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart diseaseClara Chow0John Amerena1Marj Moodie2Kylie Ball3Brian Oldenburg4Jonathan Rawstorn5Sarah McNaughton6Karen Lamb7Voltaire Nadurata8Christopher Neil9Stuart Cameron10Department of Cardiology, Westmead Hospital, Westmead, New South Wales, AustraliaCardiac Services, Barwon Health, Geelong, Victoria, AustraliaSchool of Health and Social Development, Deakin University, Burwood, Victoria, Australia1 School of Exercise and Nutrition Sciences, Deakin University Institute for Physical Activity and Nutrition, Geelong, Victoria, AustraliaNossal Institute for Global Health, University of Melbourne School of Population and Global Health, Melbourne, Victoria, AustraliaInstitute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, AustraliaSchool of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, AustraliaSchool of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia4 Department of Cardiology, Bendigo Health, Bendigo, Victoria, AustraliaBaker Heart and Diabetes Institute, Melbourne, Victoria, AustraliaApplied Artificial Intelligence Institute, Deakin University, Melbourne, Victoria, AustraliaIntroduction It is important to ascertain the cost-effectiveness of alternative services to traditional cardiac rehabilitation while the economic credentials of the Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) programme among people with coronary heart disease (CHD) are unknown. This economic protocol outlines the methods for undertaking a trial-based economic evaluation of SCRAM in the real-world setting in Australia.Methods and analysis The within-trial economic evaluation will be undertaken alongside a randomised controlled trial (RCT) designed to determine the effectiveness of SCRAM in comparison with the usual care cardiac rehabilitation (UC) alone in people with CHD. Pathway analysis will be performed to identify all the costs related to the delivery of SCRAM and UC. Both a healthcare system and a limited societal perspective will be adopted to gauge all costs associated with health resource utilisation and productivity loss. Healthcare resource use over the 6-month participation period will be extracted from administrative databases (ie, Pharmaceutical Benefits Scheme and Medical Benefits Schedule). Productivity loss will be measured by absenteeism from work (valued by human capital approach). The primary outcomes for the economic evaluation are maximal oxygen uptake (VO2max, mL/kg/min, primary RCT outcome) and quality-adjusted life years estimated from health-related quality of life as assessed by the Assessment of Quality of Life-8D instrument. The incremental cost-effectiveness ratio will be calculated using the differences in costs and benefits (ie, primary and secondary outcomes) between the two randomised groups from both perspectives with no discounting. All costs will be valued in Australian dollars for year 2020.Ethics and dissemination The study protocol has been approved under Australia’s National Mutual Acceptance agreement by the Melbourne Health Human Research Ethics Committee (HREC/18/MH/119). It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia. The evaluation will provide evidence to underpin national scale-up of the programme to a wider population. The results of the economic analysis will be submitted for publication in a peer-reviewed journal.Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12618001458224).https://bmjopen.bmj.com/content/10/8/e038178.full |
| spellingShingle | Clara Chow John Amerena Marj Moodie Kylie Ball Brian Oldenburg Jonathan Rawstorn Sarah McNaughton Karen Lamb Voltaire Nadurata Christopher Neil Stuart Cameron Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease BMJ Open |
| title | Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease |
| title_full | Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease |
| title_fullStr | Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease |
| title_full_unstemmed | Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease |
| title_short | Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease |
| title_sort | economic evaluation protocol for a multicentre randomised controlled trial to compare smartphone cardiac rehabilitation assisted self management scram versus usual care cardiac rehabilitation among people with coronary heart disease |
| url | https://bmjopen.bmj.com/content/10/8/e038178.full |
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