title: Improving delivery of secondary prophylaxis for rheumatic heart disease in remote Indigenous communities: study protocol for a stepped-wedge randomised trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry: ACTRN12613000223730. Date registered: 25 February 2013.
authors.affiliation: Menzies School of Health Research, Darwin, NT, Australia. Anna.Ralph@menzies.edu.au.
authors.forename: Anna P
authors.initials: AP
authors.lastname: Ralph
authors.affiliation: Telethon Kids Institute, University of Western Australia, and Princess Margaret Hospital for Children, Perth, WA, Australia. Clancy.Read@telethonkids.org.au.
authors.forename: Clancy
authors.initials: C
authors.lastname: Read
authors.affiliation: Menzies School of Health Research, Darwin, NT, Australia. Vanessa.Johnston@menzies.edu.au.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Johnston
authors.affiliation: Menzies School of Health Research, Darwin, NT, Australia. jess.dedassel@menzies.edu.au.
authors.forename: Jessica L
authors.initials: JL
authors.lastname: de Dassel
authors.affiliation: Menzies School of Health Research, Darwin, NT, Australia. Kerstin.Bycroft@menzies.edu.au.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Bycroft
authors.affiliation: Charles Darwin University, Darwin, NT, Australia. Alice.Mitchell@menzies.edu.au.
authors.forename: Alice
authors.initials: A
authors.lastname: Mitchell
authors.affiliation: Menzies School of Health Research, Darwin, NT, Australia. Ross.Bailie@menzies.edu.au.
authors.forename: Ross S
authors.initials: RS
authors.lastname: Bailie
authors.affiliation: Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia. Graeme.Maguire@bakeridi.edu.au.
authors.forename: Graeme P
authors.initials: GP
authors.lastname: Maguire
authors.affiliation: Paediatric Department, Royal Darwin Hospital, Darwin, NT, Australia. Keith.Edwards@nt.gov.au.
authors.forename: Keith
authors.initials: K
authors.lastname: Edwards
authors.affiliation: Menzies School of Health Research, Darwin, NT, Australia. Bart.Currie@menzies.edu.au.
authors.forename: Bart J
authors.initials: BJ
authors.lastname: Currie
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia. Adrienne.Kirby@ctc.usyd.edu.au.
authors.forename: Adrienne
authors.initials: A
authors.lastname: Kirby
authors.affiliation: Telethon Kids Institute, University of Western Australia, and Princess Margaret Hospital for Children, Perth, WA, Australia. jonathan.carapetis@telethonkids.org.au.
authors.forename: Jonathan R
authors.initials: JR
authors.lastname: Carapetis
mesh_terms: D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D006801:Humans; D055118:Medication Adherence; D017063:Outcome Assessment, Health Care; D058996:Quality Improvement; D012111:Residence Characteristics; D012214:Rheumatic Heart Disease / Q000517:prevention & control*; D018401:Sample Size; D055502:Secondary Prevention
references.citation: World Health Organ Tech Rep Ser. 2004;923:1-122, back cover
references.pmid: 15382606
references.citation: Aust J Rural Health. 2003 Dec;11(6):260-5
references.pmid: 14678407
references.citation: J Health Serv Res Policy. 2001 Apr;6(2):123-6
references.pmid: 11357244
references.citation: Med J Aust. 2005 Sep 19;183(6):305-9
references.pmid: 16167870
references.citation: Circulation. 2013 Jul 30;128(5):492-501
references.pmid: 23794730
references.citation: Med J Aust. 2007 May 21;186(10):525-7
references.pmid: 17516901
references.citation: Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011
references.pmid: 18425859
references.citation: Cardiovasc J Afr. 2008 May-Jun;19(3):135-40
references.pmid: 18568172
references.citation: BMJ. 2004 Jun 26;328(7455):1561-3
references.pmid: 15217878
references.citation: BMC Health Serv Res. 2013 Dec 18;13:525
references.pmid: 24350582
references.citation: Singapore Med J. 1973 Sep;14(3):457-61
references.pmid: 4777936
references.citation: Heart. 2005 Sep;91(9):1131-3
references.pmid: 16103536
references.citation: Cochrane Database Syst Rev. 2002;(3):CD002227
references.pmid: 12137650
references.citation: Heart Lung Circ. 2015 May;24(5):450-7
references.pmid: 25541229
references.citation: N Engl J Med. 1973 Aug 16;289(7):331-5
references.pmid: 4740466
references.citation: Aust N Z J Public Health. 2008 Dec;32(6):554-8
references.pmid: 19076748
references.citation: Heart Lung Circ. 2010 May-Jun;19(5-6):372-7
references.pmid: 20356790
references.citation: Curr Top Microbiol Immunol. 2013;368:1-27
references.pmid: 23242849
references.citation: BMJ. 2006 Feb 18;332(7538):413-6
references.pmid: 16484270
references.citation: Lancet. 1996 Mar 9;347(9002):644-8
references.pmid: 8596378
references.citation: Med J Aust. 2006 May 15;184(10):514-7
references.pmid: 16719752
references.citation: Health Aff (Millwood). 2001 Nov-Dec;20(6):64-78
references.pmid: 11816692
references.citation: BMC Med Res Methodol. 2006 Nov 08;6:54
references.pmid: 17092344
references.citation: BMC Health Serv Res. 2007 May 06;7:67
references.pmid: 17480239
references.citation: Trials. 2015 Aug 17;16:352
references.pmid: 26279154