Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001247561p
Ethics application status
Submitted, not yet approved
Date submitted
26/10/2015
Date registered
13/11/2015
Date last updated
13/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of cardiac rehabilitation and secondary prevention uptake and utilisation for acute coronary syndrome patients.
Scientific title
Evaluation of quality of care in cardiac rehabilitation for acute coronary syndrome patients.
Secondary ID [1] 287731 0
NIL
Universal Trial Number (UTN)
U1111-1175-8173
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 296577 0
Condition category
Condition code
Cardiovascular 296832 296832 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Based on data collected from the first cycle of clinical audit, as well as surveys and group discussions, quality improvement initiatives will be developed and implanted. This may include redesigning the cardiac rehabilitation referral system, improving patient education program, developing advocacy programs for cardiac rehabilitation and secondary prevention among patients and staff, developing alternative models of cardiac rehabilitation and secondary prevention etc.
2. After the first cycle of clinical audit, current ACS patients will be asked to complete a survey (and some to attend focus groups) and Cardiology Ward staff will be invited to complete a survey (and some attend individual interviews with the researchers).
3. Quality improvement initiatives will be developed and implanted between the two audit cycles within a period of 6 months. The effectiveness of the initiatives will be evaluated through the second cycle of clinical audit.
Intervention code [1] 293124 0
Other interventions
Comparator / control treatment
This study will consist two six-month audit cycles of consecutively admitted ACS patients with performance improvement strategies developed and implemented in between. Data from 1st and 2nd cycle of clinical audit will be act as controal group and intervention group respectively. Data from two groups will be compared to quantitatively evaluate the effectiveness of the quality improvement initiatives.
Control group
Active

Outcomes
Primary outcome [1] 296440 0
Change in the number of admitted ACS patients receiving core components of cardiac rehabilitation. This the outcome will be assessed through the second cycle of clinical audit by review of medical records, FSH electronic referral system with indicators including referral rates, participation and completion rates of cardiac rehabilitation etc.
Timepoint [1] 296440 0
3 months after performance improvement strategies developed and implemented.
Primary outcome [2] 296565 0
Change in the number of admitted ACS patients receiving guideline advocated secondary prevention therapies. This the outcome will be assessed through the second cycle of clinical audit by review medical records with indicators including utilization of evidence based medecine, referral for cardiac rehabilitation program, risk factor monitoring and control etc.
Timepoint [2] 296565 0
3 months after performance improvement strategies developed and implemented.
Secondary outcome [1] 318571 0
Cardiac rehabilitation refferal rates will be monitored by using the electronic cardiac rehabilitation referral system after the implementation of quality improvement initiatives..
Timepoint [1] 318571 0
6 months after performance improvement strategies developed and implemented.

Eligibility
Key inclusion criteria
Clinical Audit: All patients admitted at FSH with a diagnosis of ACS during the two cycles of audit (for the six month periods beginning 1 January 2016 and 2017 respectively) will be included in the Audit.

Patient Survey: Current patients admitted to FSH with an ACS during the strudy period.

Staff Survey: Currently employed staff who working at cardiology department of FSH as a care giver providing cardiology service to both outpatient and inpatient are eligible to participate the study.

Patient Focus Groups & Staff Interviews: One in four of the patients who returned surveys will be randomly selected and contacted by a phone call from the research team to take part in focus group discussions. Similarly, staff will be randomly selected to take part in face-to-face interviews subsequent to the surveys since it is unlikely to be possible to arrange a group discussion for medical/health staff in a busy clinical setting.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hospitality mortality data will be reviewed and invitation letters or phone calls for participating the survey and focus group discussion will not be sent to the addresses of deceased patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
For the clinical audits, approximately 1000 patients are admitted to FSH annually with ACS, therefore an estimated 500 patients will be audited for each of the audit cycles. As for the surveys, based on prior studies and using the formula of Necessary Sample Size=(Z-score)2*Standard Deviation*(1-Standard Deviation)/(margin of error)2, a sample size of 100 patients will have a confidence interval >91% (margin of error ~8.7%, Standard Deviation 0.5). Focus group discussions will be conducted within randomly selected patient participants from the surveys, it is anticipate five groups will be needed, each group will consist of 6-8 participants with mix of age and genders, and there will be four groups of patients. Similarly, staff will be randomly selected to take part in face-to-face interviews subsequent to the surveys since it is unlikely to be possible to arrange a group discussion for medical/health staff in a busy clinical setting. Focus group discussions and semi-structured interviews will cease once data saturation is reached.

Clinical Audit: Approximately 1000 patients are admitted to FSH annually with ACS, therefore an estimated 500 patients will be audited for each of the audit cycles.

Patient Survey: Between the two cycles of clinical audit, invitation letters will be mailed to 200 ACS patients, we anticipate that approximately 50% of patients receiving the invitation will consent to participating, based on previous experiences of survey mail outs. This would provide approximately 100 surveys returned which we anticipate will be appropriate to reflect the broad range of patient's opinions and experiences require to inform the development of focus group discussion points.

Staff Survey: Approximately 100 nursing, medical staff and allied health staff provide inpatient and outpatient cardiology care at FSH. We anticipate a slightly higher rate of consent to participate in the study amongst this group of approximately 60% i.e. approximately 60 surveys. This number will be sufficient to reflect a range of staff opinions.

Patient Focus Groups & Staff Interviews: Base on previous studies and experiences, it is anticipated that five patient participants focus group discussions with each group consists of 6-8 participants with mix of age and genders, and 10 face-to-face interviews with staff participants will be needed.

A maximum variation sampling technique will be used to ensure a wide diversity of opinions. SPSS software will be used to analyse the findings. A quality improvement framework will be employed to aid in cardiac rehabilitation service redesign through a continuous improvement design of evaluation, adjustment and re-evaluation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2015
Actual
Date of last participant enrolment
Anticipated
30/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4502 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 12115 0
6149 - Bull Creek
Recruitment outside Australia
Country [1] 7273 0
China
State/province [1] 7273 0
Qinghai

Funding & Sponsors
Funding source category [1] 292274 0
University
Name [1] 292274 0
Curtin University PhD student research funding
Country [1] 292274 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth Western Australia. 6102
Country
Australia
Secondary sponsor category [1] 290952 0
None
Name [1] 290952 0
Address [1] 290952 0
Country [1] 290952 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293749 0
Royal Perth Hospital HREC
Ethics committee address [1] 293749 0
Southern Integrated Research Organisation (SIRO)

Level 2, Southern Research Facility (Perkins South Building)

102 – 118 Murdoch Drive

Murdoch WA 6150

Locked Bag 100 Palmyra DC WA 6961
Ethics committee country [1] 293749 0
Australia
Date submitted for ethics approval [1] 293749 0
20/10/2015
Approval date [1] 293749 0
Ethics approval number [1] 293749 0

Summary
Brief summary
Cardiovascular disease (CVD) is the most common cause of morbidity and premature death worldwide. It is projected that the number of fatalities related to CVD will increase to more than 24 million annually by 2030. In Australia, 1 in every 5 adults had CVD based on self-reported data, and 11% of all hospitalizations are caused by this deadly disease. The growing epidemic of CVD has resulted in calls for a universal model of care to provide rehabilitative and preventive services for all patients with this disease.

Cardiac rehabilitation/secondary prevention programs (CR/SPPs) are medically supervised programs that help patients with CVD to recover more quickly after a cardiac event and to stay healthy. CR/SPPs have been shown to reduce readmission and mortality. However, despite the accumulating evidence and potential benefits, less than 30% of eligible patients participated in CR/SPPs.

The aim of this project is to assess the current status of CR/SP services at Fiona Stanley Hospital (FSH), identify strengths and limitations of the CR/SP program and to develop and implement strategies for improvement of services. This will involve review of previous data from medical records relating to the CR/SP program and a continuous quality improvement approach to refine services in accordance with international best practice.

The project will use a mixed methods research approach. First, an audit of medical records will be performed to objectively quantify CR/SP referral, attendance and completion rates amongst acute coronary syndrome (ACS) patients at FSH. Second, stakeholder surveys, focus group discussions and face-to-face interviews will be conducted to investigate barriers and facilitators to CR/SP service provision. For this second stage, current patients will be asked to complete a survey (and some to attend focus groups) and Cardiology Ward staff will be invited to complete a survey (and some attend individual interviews with the researchers).

This information will be used to guide changes to CR/SP systems with the objective of increasing the number of patients receiving the core components of CR/SP program: assessment, nutritional counseling, aggressive risk factor management (ie, lipids, hypertension, weight, diabetes mellitus, and smoking), psychosocial and vocational counseling, and physical activity counseling and exercise training.

Study summary
1. Audit: Two six-month audit cycles of consecutively admitted ACS patients will be conducted (for the six month periods beginning 1 January 2016 and 2017 respectively) with CR/SP program performance improvement strategies developed and implemented in between;
2. Patient and staff surveys: 100 ACS patients and 50 staff who work on the cardiology ward will be recruited to participate in the second part of the study with the completion of a survey;
3. Focus group discussions and interviews: Subsequent to the surveys, 30 patient participants and 10 staff participants will be invited to take part in focus group discussions and face-to-face interviews respectively. The responses from the surveys will be evaluated to establish common themes and to guide discussions in the focus groups.

Although the project at FSH is an independent process monitoring and quality improvement initiative, it is also a key component of a larger project that aims to develop culturally appropriate CR/SP models for two mainland Chinese populations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61154 0
A/Prof Andrew Maiorana
Address 61154 0
Fiona Stanley Hospital
Advanced Heart Failure and Cardiac Transplant Service Clinic.
11 Robin Warren Drive Murdoch, WA 6150.
Country 61154 0
Australia
Phone 61154 0
+61 8 9266 9225
Fax 61154 0
Email 61154 0
Andrew.Maiorana@health.wa.gov.au
Contact person for public queries
Name 61155 0
A/Prof Andrew Maiorana
Address 61155 0
Fiona Stanley Hospital
Advanced Heart Failure and Cardiac Transplant Service Clinic.
11 Robin Warren Drive Murdoch, WA 6150
Country 61155 0
Australia
Phone 61155 0
+61 8 9266 9225
Fax 61155 0
Email 61155 0
Andrew.Maiorana@health.wa.gov.au
Contact person for scientific queries
Name 61156 0
A/Prof Andrew Maiorana
Address 61156 0
Fiona Stanley Hospital
Advanced Heart Failure and Cardiac Transplant Service Clinic.
11 Robin Warren Drive Murdoch, WA 6150.
Country 61156 0
Australia
Phone 61156 0
+61 8 9266 9225
Fax 61156 0
Email 61156 0
Andrew.Maiorana@health.wa.gov.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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