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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Improving delivery of secondary prophylaxis for rheumatic heart disease in remote Indigenous communities: study protocol for a stepped-wedge randomised trial

Authors: Anna P. Ralph, Clancy Read, Vanessa Johnston, Jessica L. de Dassel, Kerstin Bycroft, Alice Mitchell, Ross S. Bailie, Graeme P. Maguire, Keith Edwards, Bart J. Currie, Adrienne Kirby, Jonathan R. Carapetis

Published in: Trials | Issue 1/2016

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Abstract

Background

Rheumatic heart disease (RHD), caused by acute rheumatic fever (ARF), is a major health problem in Australian Aboriginal communities. Progress in controlling RHD requires improvements in the delivery of secondary prophylaxis, which comprises regular, long-term injections of penicillin for people with ARF/RHD.

Methods/Design

This trial aims to improve uptake of secondary prophylaxis among Aboriginal people with ARF/RHD to reduce progression or worsening of RHD. This is a stepped-wedge, randomised trial in consenting communities in Australia’s Northern Territory. Pairs of randomly-chosen clinics from among those consenting enter the study at 3-monthly steps. The intervention to which clinics are randomised comprises a multi-faceted systems-based package, in which clinics are supported to develop and implement strategies to improve penicillin delivery, aligned with elements of the Chronic Care Model. Continuous quality improvement processes will be used, including 3-monthly feedback to clinic staff of adherence rates of their ARF/RHD clients.
The primary outcome is the proportion of people with ARF/RHD receiving ≥80 % of scheduled penicillin injections over a minimum 12-month period. The sample size of 300 ARF/RHD clients across five community clusters will power the study to detect a 20 % increase in the proportion of individuals achieving this target, from a worrying low baseline of 20 %, to 40 %. Secondary outcomes pertaining to other measures of adherence will be assessed. Within the randomised trial design, a mixed-methods evaluation will be embedded to evaluate the efficiency, effectiveness, impact and relevance, sustainability, process and fidelity, and performance of the intervention. The evaluation will establish any causal link between outcomes and the intervention. The planned study duration is from 2013 to 2016.

Discussion

Continuous quality improvement has a strong track record in Australia’s Northern Territory, and its use has resulted in modest benefits in a pilot, non-randomised ARF/RHD study. If successful, this new intervention using the Chronic Care Model as a scaffold and evaluated using a well-developed theory-based framework, will provide a practical and transferable approach to ARF/RHD control.

Trial registration

Australian New Zealand Clinical Trials Registry: ACTRN12613000223​730. Date registered: 25 February 2013
Appendix
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Metadata
Title
Improving delivery of secondary prophylaxis for rheumatic heart disease in remote Indigenous communities: study protocol for a stepped-wedge randomised trial
Authors
Anna P. Ralph
Clancy Read
Vanessa Johnston
Jessica L. de Dassel
Kerstin Bycroft
Alice Mitchell
Ross S. Bailie
Graeme P. Maguire
Keith Edwards
Bart J. Currie
Adrienne Kirby
Jonathan R. Carapetis
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1166-y

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