Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001239651
Ethics application status
Approved
Date submitted
17/10/2023
Date registered
30/11/2023
Date last updated
30/11/2023
Date data sharing statement initially provided
30/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identifying and addressing barriers and enablers to implementing best-practice cardiac rehabilitation: the Quality Improvement in Cardiac Rehabilitation (QUICR) Cluster-Randomised Controlled Trial
Scientific title
Identifying and addressing barriers and enablers to implementing best-practice cardiac rehabilitation for cardiac rehabilitation health professionals: the Quality Improvement in Cardiac Rehabilitation (QUICR) Cluster-Randomised Controlled Trial
Secondary ID [1] 310534 0
nil
Universal Trial Number (UTN)
Trial acronym
QUICR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 331793 0
Condition category
Condition code
Cardiovascular 328703 328703 0 0
Coronary heart disease
Public Health 328704 328704 0 0
Health service research
Physical Medicine / Rehabilitation 328705 328705 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CR program sites allocated to the intervention arm will receive a multicomponent intervention package, including:
1. Data Dashboard and Monthly Reports
CR program sites will enter patient data into the REDCap data collection platform and will be provided with monthly reports summarising this data for each quality indicator assessed. Quality indicators include comprehensive assessment, depression screening, smoking assessment, assessment of medication adherence, exercise capacity, health related quality of life, and wait time to enrolment. Data from REDCap will automatically be transferred into a dashboard, which generates reports that will be provided to intervention sites every month. CR sites will have a designated identifying number. The monthly report will include the site’s own data as well as the aggregate data of all other sites. Interpretation of monthly reporting will be facilitated by a research team member with discussion about quality improvement progress. A monthly audit of the data on REDCap will be done monthly by the research team.
2. Collaborative Quality Improvement
CR program site leaders will be supported to develop quality improvement skills using the Plan-Do-Study-Act (PDSA) method. Regular group-based workshops (n=4) (1 in-person and 3 online) will be held to assist expert clinicians use data to identify and initiate practice changes to improve patient completion that could be implemented and tested iteratively over time. The initial group-based workshop will be all-day (6-hours) and in-person for all intervention participants within three months of beginning data entry. Workshop dates will be coordinated to minimise work disruption and CR site representatives’ travel costs (air fares, fuel, taxis, and accommodation, if needed) will be covered and organised by the research team. Following the initial workshop, all workshops will be online, 2-3 hours in duration and occur every second month. The individual CR program site data reports will be discussed during the workshops and the collated reports used to identify collaborative areas for improvement and find and test potential solutions to common problems. There will be a focus on PDSA for CR program completion included in all workshops and reports. The collaborative approach will promote mutual learning among sites in addressing shared issues. The workshops will be facilitated by research team members with expertise, skills, and prior experiences in collaborative quality improvement. Cardiac rehabilitation staff (registered nurses, exercise physiologists, cardiac rehabilitation coordinators, cardiac rehabilitation managers) are eligible to attend the workshops. A minimum of one staff member per site will be required to attend the workshops over the 12 month period of the study. The workshops will be delivered both in person and virtually to accomodate participation of all study site coordinators.

3. Facilitation and Support
Aside from individual facilitated monthly reports and discussion with CR program sites. All participating intervention group CR program site staff will have access to a SharePoint site as repository for resources, for example, documents on how to write a PDSA statement, interpreting the monthly reports, and the contact details of the research team to discuss issues during business hours for the entire study duration. These support channels will ensure closer adherence to the PDSA method and the collaborative goals, as well as the opportunity to clarify queries with the research team. Participants are required to access the monthly data reports via Sharepoint once generated throughout the 12 month period. Sharepoint analytics will be used to monitor engagement of cardiac rehabilitation coordinators and staff members. Personalised check ins with all sites allocated to the intervention group will be provided throughout the 12 month period to ensure they understand the data reports.
Intervention code [1] 327213 0
Behaviour
Comparator / control treatment
CR sites allocated in the control arm (usual care) will enter patient data into the purpose-built REDCap platform (taking approximately 30mins/week), but no reports will be generated and given to them. A monthly audit of the data on REDCap will be done monthly by the research team to ensure data is entered correctly. These sites will not receive facilitation or additional support from the research team. The duration of the control treatment is 12 months. Sites will be provided with QUICR intervention workshop materials following study outcome completion.
Control group
Active

Outcomes
Primary outcome [1] 336345 0
Cardiac rehabilitation program completion (answers yes to the question "has this patient completion the cardiac rehabilitation program?") on the REDCap questionniare.
Timepoint [1] 336345 0
12 months from commencement of data entry on REDCap
Secondary outcome [1] 427935 0
unplanned hospitalisations (using administrative data collected from NSW Centre for Health Record Linkage (CHeReL) and The Centre for Victorian Data Linkage)
Timepoint [1] 427935 0
12 and 24 months from commencement of data entry on REDCap
Secondary outcome [2] 427936 0
Proportion of patients receiving timely commencement of cardiac rehabilitation program (wait-time <4 weeks)
Timepoint [2] 427936 0
12 months from commencement of data entry on REDCap
Secondary outcome [3] 427937 0
exercise capacity using a validated tool (for example six minute walk test, incremental shuffle walk test, sit to stand test)
Timepoint [3] 427937 0
12 months from commencement of data entry on REDCap
Secondary outcome [4] 427938 0
cost-effectiveness by patient out of pocket costs (eg transport to and from the program, parking), calculating difference between resource use and costs from medical records, time taken off work in hours to complete the program.
Timepoint [4] 427938 0
12 months from commencement of data entry on REDCap
Secondary outcome [5] 428649 0
associated length of stay using administrative data collected from NSW Centre for Health Record Linkage (CHeReL) and The Centre for Victorian Data Linkage)
Timepoint [5] 428649 0
12 months from commencement of data entry on REDCap
Secondary outcome [6] 428650 0
emergency department presentations using administrative data collected from NSW Centre for Health Record Linkage (CHeReL) and The Centre for Victorian Data Linkage,
Timepoint [6] 428650 0
12 months from commencement of data entry on REDCap
Secondary outcome [7] 428651 0
proportion of patients receiving a comprehensive risk factor assessment at entry and completion (answers yes to all the questions" Smoking screened", "Depression screened" and "Health-related quality of life assessed" on the REDCap questionnaire)
Timepoint [7] 428651 0
12 month from commencement of data entry on REDCap
Secondary outcome [8] 428652 0
proportion of patients receiving medication adherence assessment and counselling (composite secondary outcome) (answers yes to the question "Medication adherence assessed" and answers appropriately "how often does the patient taking heart medications" on the REDCap questionnaire)
Timepoint [8] 428652 0
12 months from commencement of data entry on REDCap
Secondary outcome [9] 428653 0
proportion of patients receiving transition plan documentation in adults with coronary heart disease (CHD) (answers yes to the question "Documented communication of ongoing management plan for patient and GP" on the REDCap questionnaire)
Timepoint [9] 428653 0
12 months from commencement of data entry on REDCap
Secondary outcome [10] 428655 0
health related quality of life using a validated tool (EQ-5D)
Timepoint [10] 428655 0
12 months from commencement of data entry on REDCap

Eligibility
Key inclusion criteria
• Cardiac rehabilitation programs:
- enrols at least 70 patients with coronary heart disease per year
- have internet-enabled computers
- staff have access to and proficiency with using an electronic data platform
- provide written agreement to participate in the study
• A dataset of patients who enrol in the cardiac rehabilitation programs:
- consecutive patients enrolled in participating cardiac rehabilitation program sites who are 18 years and over with a documented diagnosis of coronary heart disease in the medical record
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
CR programs already participating in a formal/structured/research-based quality improvement program for patients with CHD.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/10/2023
Date of last participant enrolment
Anticipated
22/12/2023
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
2800
Accrual to date
280
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 314735 0
Government body
Name [1] 314735 0
Australian Government Department of Health and Aged Care: Medical Research Future Fund
Country [1] 314735 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 317065 0
None
Name [1] 317065 0
Address [1] 317065 0
Country [1] 317065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313745 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 313745 0
NSLHD Research Office, Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Ethics committee country [1] 313745 0
Australia
Date submitted for ethics approval [1] 313745 0
22/05/2023
Approval date [1] 313745 0
11/10/2023
Ethics approval number [1] 313745 0
2023/ETH01093

Summary
Brief summary
Our primary aim is to determine whether implementation of a data-driven collective approach to best practice cardiac rehabilitation, which addresses shared gaps in quality and access improves CR uptake and completion in CHD patients. The collective approach will be supported by an electronic data platform. Clinical, service and patient-reported outcomes and cost-effectiveness will be assessed. In partnership with CR programs, we will evaluate barriers and enablers to best practice care, develop a framework for scale-up and establish sustainable collaborations. We hypothesise that a collaborative quality improvement approach is feasible, improves outcomes and offers a novel approach that can be replicated in other outpatient health areas.
Trial website
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 129218 0
Prof Robyn Gallagher
Address 129218 0
University of Sydney Camperdown NSW 2050
Country 129218 0
Australia
Phone 129218 0
+61 409786305
Fax 129218 0
Email 129218 0
robyn.gallagher@sydney.edu.au
Contact person for public queries
Name 129219 0
Dr Dion Candelaria
Address 129219 0
University of Sydney Camperdown NSW 2050
Country 129219 0
Australia
Phone 129219 0
+61 450318623
Fax 129219 0
Email 129219 0
dion.candelaria@sydney.edu.au
Contact person for scientific queries
Name 129220 0
Dr Dion Candelaria
Address 129220 0
University of Sydney Camperdown NSW 2050
Country 129220 0
Australia
Phone 129220 0
+61 450318623
Fax 129220 0
Email 129220 0
dion.candelaria@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20964Ethical approval    386540-(Uploaded-17-11-2023-16-16-28)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.