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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

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journal contribution
posted on 2024-06-18, 22:47 authored by Lan GaoLan Gao, Ralph MaddisonRalph Maddison, Jonathan RawstornJonathan Rawstorn, Kylie BallKylie Ball, B Oldenburg, C Chow, Sarah McNaughtonSarah McNaughton, K Lamb, J Amerena, V Nadurata, C Neil, Stuart CameronStuart Cameron, Marj MoodieMarj Moodie
IntroductionIt 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 analysisThe 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 disseminationThe 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 numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001458224).

History

Journal

BMJ Open

Volume

10

Article number

ARTN e038178

Pagination

1 - 8

Location

England

Open access

  • Yes

ISSN

2044-6055

eISSN

2044-6055

Language

English

Publication classification

C1 Refereed article in a scholarly journal

Issue

8

Publisher

BMJ PUBLISHING GROUP