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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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Health economics
Protocol
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
  1. Lan Gao1,
  2. Ralph Maddison2,
  3. Jonathan Rawstorn2,
  4. Kylie Ball2,
  5. Brian Oldenburg3,
  6. Clara Chow4,
  7. Sarah McNaughton5,
  8. Karen Lamb6,
  9. John Amerena7,8,
  10. Voltaire Nadurata9,
  11. Christopher Neil10,
  12. Stuart Cameron11,
  13. Marj Moodie12
  1. 1Deakin Health Economics, Deakin University, Burwood, Victoria, Australia
  2. 2Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, Australia
  3. 3Nossal Institute for Global Health, University of Melbourne School of Population and Global Health, Melbourne, Victoria, Australia
  4. 4Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia
  5. 5School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia
  6. 6School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia
  7. 7Cardiac Services, Barwon Health, Geelong, Victoria, Australia
  8. 8Faculty of Health, Deakin University, Burwood, Victoria, Australia
  9. 9Department of Cardiology, Bendigo Health, Bendigo, Victoria, Australia
  10. 10Western Clinical School, The University of Melbourne, Saint Albans, Victoria, Australia
  11. 11Applied Artificial Intelligence Institute, Deakin University, Burwood, Victoria, Australia
  12. 12School of Health and Social Development, Deakin University, Burwood, Victoria, Australia
  1. Correspondence to Dr Lan Gao; lan.gao{at}deakin.edu.au

Abstract

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).

  • health economics
  • rehabilitation medicine
  • myocardial infarction
  • coronary heart disease
http://creativecommons.org/licenses/by-nc/4.0/

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/.

https://doi.org/10.1136/bmjopen-2020-038178

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    Footnotes

    • Twitter @jrawstorn

    • Contributors All the authors contributed to the study design and the protocol of the economic analysis. LG drafted the initial manuscript. RM, JR, KB, BO, CC, SM, KL, JA, VN, CN, SC and MM reviewed, edited and approved the final manuscript.

    • Funding This study is funded by the Australian National Health and Medical Research Council (project grant 1144331).

    • Competing interests None declared.

    • Patient consent for publication Obtained.

    • Provenance and peer review Not commissioned; externally peer reviewed.