Please use this identifier to cite or link to this item: http://docs.prosentient.com.au/prosentientjspui/handle/1/10424
Title: Improving delivery of secondary prophylaxis for rheumatic heart disease in remote Indigenous communities: study protocol for a stepped-wedge randomised trial.
Authors: Ralph, Anna P
Read, Clancy
Johnston, Vanessa
de Dassel, Jessica L
Bycroft, Kerstin
Mitchell, Alice
Bailie, Ross S
Maguire, Graeme P
Edwards, Keith
Currie, Bart J
Kirby, Adrienne
Carapetis, Jonathan R
Affiliation: Menzies School of Health Research, Darwin, NT, Australia. Anna.Ralph@menzies.edu.au..
Telethon Kids Institute, University of Western Australia, and Princess Margaret Hospital for Children, Perth, WA, Australia. Clancy.Read@telethonkids.org.au..
Menzies School of Health Research, Darwin, NT, Australia. Vanessa.Johnston@menzies.edu.au..
Menzies School of Health Research, Darwin, NT, Australia. jess.dedassel@menzies.edu.au..
Menzies School of Health Research, Darwin, NT, Australia. Kerstin.Bycroft@menzies.edu.au..
Charles Darwin University, Darwin, NT, Australia. Alice.Mitchell@menzies.edu.au..
Menzies School of Health Research, Darwin, NT, Australia. Ross.Bailie@menzies.edu.au..
Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia. Graeme.Maguire@bakeridi.edu.au..
Paediatric Department, Royal Darwin Hospital, Darwin, NT, Australia. Keith.Edwards@nt.gov.au..
Menzies School of Health Research, Darwin, NT, Australia. Bart.Currie@menzies.edu.au..
National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia. Adrienne.Kirby@ctc.usyd.edu.au..
Telethon Kids Institute, University of Western Australia, and Princess Margaret Hospital for Children, Perth, WA, Australia. jonathan.carapetis@telethonkids.org.au..
Issue Date: 27-Jan-2016
Citation: Trials 2016-01-27; 17: 51
Abstract: 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. 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. 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. Australian New Zealand Clinical Trials Registry: ACTRN12613000223730. Date registered: 25 February 2013.
URI: http://docs.prosentient.com.au/prosentientjspui/handle/1/10424
DOI: 10.1186/s13063-016-1166-y
Type: Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Subjects: Data Interpretation, Statistical
Humans
Medication Adherence
Outcome Assessment (Health Care)
Quality Improvement
Residence Characteristics
Rheumatic Heart Disease
Sample Size
Clinical Protocols
Secondary Prevention
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