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Trial registered on ANZCTR


Registration number
ACTRN12613000223730
Ethics application status
Approved
Date submitted
13/02/2013
Date registered
25/02/2013
Date last updated
12/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving delivery of secondary prophylaxis for rheumatic heart disease
Scientific title
Improving delivery of secondary prophylaxis for rheumatic heart disease: a stepped-wedge, community-randomised trial to increase proportion of clients receiving 80% or more of scheduled benzathine penicillin G injections.
Secondary ID [1] 281894 0
Nil
Universal Trial Number (UTN)
Trial acronym
RHD SP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatic Heart Disease 288293 0
Acute Rheumatic Fever 288294 0
Condition category
Condition code
Cardiovascular 288637 288637 0 0
Other cardiovascular diseases
Public Health 288728 288728 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve the incorporation/modification of service delivery activities aligned with the chronic care model at the health centre level, specifically relating to care for clients with acute rheumatic fever (ARF) or rheumatic heart disease (RHD). The research team will work with health centre staff, continuous quality improvement facilitators and the Northern Territory RHD program to review existing practices and data and develop activity plans to realign the health centre's approach with the Chronic Care Model. This preparation has been allocated three months in the projects timeline. After this three month period, the modified processes should be implemented and this signifies the commencement of the intervention period. Possible activities include: the creation of an RHD working group at each health centre; the allocation and documentation of RHD service delivery responsibilities; streamlining triaging processes; strengthening self management initiatives and developing/strengthening links with community. During the first 15 months of the intervention health centres will receive intensive support from the project team; this will be followed by a maintenance phase with a reduced level of support. For the first sites to be randomised the maintenance phase will be 15 months.
Intervention code [1] 286458 0
Prevention
Comparator / control treatment
This is a stepped wedge design and as such all participating health centres will receive the intervention. The pre-intervention phase for each health centre will act as the control treatment. During the pre-intervention phase health centres will conduct their regular activities with respect to service delivery for ARF/RHD clients. The approach taken in each health centre may vary slightly; activities are often developed as part of continuous quality control processes, this is particularly true for health centres who undertake One21seventy systems assessment tools and clinical audits. Baseline data collection will take place during this phase. The pre intervention phase commenced in September 2013. The first 2 health centres to commence the intervention will have a 3 month pre intervention phase; every three months another two health centres will commence the intervention phase so that the last two health centres to commence will have a preintervention phase of 15 months.
Control group
Active

Outcomes
Primary outcome [1] 288793 0
The proportion of clients receiving 80% or more of scheduled benzathine penicillin G (BPG) injections over a minimum 12 month period. Monthly adherence data are routinely reported by health centre staff and data are stored by the RHD register. The project will use the NT RHD register data for this outcome.
Timepoint [1] 288793 0
The primary outcome will be measured on a monthly basis for the 15 months of the intervention. Due to a potential delay in intervention effect, the average adherence for months 3 -15 will be used to compare with the baseline period.
Secondary outcome [1] 301000 0
a. the acceptability of intervention package by health service staff, ARF/RHD clients, and other RHD stakeholders.
Acceptability will be measured using interview and focus groups with ARF/RHD clients and health centre staff. Focus group and interview guides are currently in development.
Timepoint [1] 301000 0
Acceptability of the package will be measured half way through the intervention period and at the end of the intervention.
Secondary outcome [2] 301001 0
b. the intervention's impact on other services for RHD clients. The intervention's impact on other services for ARF/RHD clients will be measured using the One21seventy clinical audit and systems assessment tool wherever possible. If a health centre has adopted a different system for continuous quality improvement (CQI) of RHD services, that process will be used. The research team will ensure that a comparable data set is collected from all health centres, which may involve asking additional questions at health centres not using One21seventy tool. If no RHD-specific CQI process is in place, the One21seventy tools will be used by the research team.
Timepoint [2] 301001 0
Impact on other services for ARF/RHD clients will be measured at half way and at the end of the intervention.
Secondary outcome [3] 301002 0
c. the intervention's impact on other routine services. The impact on other routine services will be measured using the Northern Territory (NT) Aboriginal Health Key Performance Indicators. These data are routinely collected by the NT Department of Health. Data for the comparison 12 months and for the intervention will be requested.
Timepoint [3] 301002 0
Impact on other routine services will be measured at half way and at the end of the intervention.

Eligibility
Key inclusion criteria
Health centres in the Northern Territory with at least 10 clients on secondary prophylaxis
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Health centres outside the Northern Territory
Health centres with less than 10 clients on secondary prophylaxis

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interested health centres will be asked to sign a participation agreement. Once 6 sites have signed participation agreements, they will be randomised in pairs to a start date. Pairs of health centres will commence at 3 months intervals. Once additional sites have signed participation agreements these will be randomised to a start date following the rollout of the first 6 sites.
Since health centres, not individuals, will be randomised, there will be no allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation).
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
The stepped-wedge community-randomised control design has been chosen for a range of reasons. The evidence to date suggests that there will be a benefit in aligning activities with the Chronic Care Model, and consequently it would be unethical to have a control group that does not receive the intervention. In addition, the limited resources available to the research team mean that simultaneous roll out of the intervention at all 10 health centres is not possible - and consequently the staggered roll out has been chosen. The stepped wedge design has been successfully used for many decades in practice based research.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2013
Actual
2/09/2013
Date of last participant enrolment
Anticipated
31/05/2016
Actual
31/05/2016
Date of last data collection
Anticipated
Actual
16/12/2016
Sample size
Target
300
Accrual to date
Final
403
Recruitment in Australia
Recruitment state(s)
NT

Funding & Sponsors
Funding source category [1] 286680 0
Government body
Name [1] 286680 0
National Health and Medical Research Council
Country [1] 286680 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Perth, Australia
Country
Australia
Secondary sponsor category [1] 285454 0
None
Name [1] 285454 0
Address [1] 285454 0
Country [1] 285454 0
Other collaborator category [1] 277272 0
University
Name [1] 277272 0
Menzies School of Health Research - Charles Darwin University
Address [1] 277272 0
PO Box 41096, Casuarina, 0811, NT, Australia
Country [1] 277272 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288747 0
Menzies School of Health Research and NT Department of Health Ethics Committee
Ethics committee address [1] 288747 0
Ethics committee country [1] 288747 0
Australia
Date submitted for ethics approval [1] 288747 0
Approval date [1] 288747 0
11/05/2012
Ethics approval number [1] 288747 0
HREC-2012-1756
Ethics committee name [2] 292810 0
Central Australian Human Research Ethics Committee
Ethics committee address [2] 292810 0
Ethics committee country [2] 292810 0
Australia
Date submitted for ethics approval [2] 292810 0
Approval date [2] 292810 0
12/06/2013
Ethics approval number [2] 292810 0
HREC-13-126

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37626 0
Prof Jonathan Carapetis
Address 37626 0
Telethon Institute for Child Health Research
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Perth, Australia
Country 37626 0
Australia
Phone 37626 0
+61 8 6488 6000
Fax 37626 0
Email 37626 0
Jonathan.Carapetis@telethonkids.org.au
Contact person for public queries
Name 37627 0
Kerstin Bycroft
Address 37627 0
Menzies School of Health Research
PO Box 41096
Casuarina
0811
NT
Country 37627 0
Australia
Phone 37627 0
+61 8 8946 8642
Fax 37627 0
Email 37627 0
Kerstin.Bycroft@menzies.edu.au
Contact person for scientific queries
Name 37628 0
Anna Ralph
Address 37628 0
Menzies School of Health Research
PO Box 41096
Casuarina
0811
NT
Country 37628 0
Australia
Phone 37628 0
+61 8946 8647
Fax 37628 0
Email 37628 0
Anna.Ralph@menzies.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEvolution, evidence and effect of secondary prophylaxis against rheumatic fever2015https://doi.org/10.4103/2395-5414.157554
EmbaseImproving delivery of secondary prophylaxis for rheumatic heart disease in remote Indigenous communities: Study protocol for a stepped-wedge randomised trial.2016https://dx.doi.org/10.1186/s13063-016-1166-y
Embase"That Heart Sickness": Young Aboriginal People's Understanding of Rheumatic Fever.2019https://dx.doi.org/10.1080/01459740.2018.1482549
N.B. These documents automatically identified may not have been verified by the study sponsor.