Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000332729
Ethics application status
Approved
Date submitted
4/02/2013
Date registered
26/03/2013
Date last updated
9/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing cost and enhancing access to disease management programs after an acute coronary event
Scientific title
Investigating a new Alternative model of Cardiac rehabilitation for Cost Effective Secondary prevention (ACCES) to increase the utilisation of existing hospital and community cardiac rehabilitation and secondary prevention amongst patients diagnosed with an acute coronary syndrome
Secondary ID [1] 281890 0
nil known
Universal Trial Number (UTN)
U1111-1139-2255
Trial acronym
ACCES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 288290 0
Condition category
Condition code
Cardiovascular 288634 288634 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 288661 288661 0 0
Other physical medicine / rehabilitation
Public Health 288670 288670 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Alternative model of cardiac rehabilitation (CR) :
Redesign of internal and external referal processes to hospital and community secondary prevention services.
Changes to Royal Perth Hospital (RPH) Cardiac rehabilitation program delivery . One key aspect is the development and implementation of a new patient needs assessment tool (in consultation with ward staff and internal and external cardiac rehab staff). The tool will be used in the ACCESS group before discharge, taking approximately 10 minutes to complete. The tool helps to assess patient learning needs and forms an individualised CR plan. Participatory action research will be utilised as changes to the needs assessment tool and its implementation process are identified. Routine follow up of all Acute coronary syndrome (ACS) patients at 3 months will also be implementedto ACCESS patients.
Intervention code [1] 286453 0
Rehabilitation
Intervention code [2] 286454 0
Prevention
Intervention code [3] 286455 0
Lifestyle
Comparator / control treatment
RPH ACS patients admitted 1 April 2011- 31 March 2012 compared to RPH ACS patients admitted 1 April 2013- 31 March 2014
Control group
Historical

Outcomes
Primary outcome [1] 288787 0
Proportion of RPH ACS patients receiving cardiac rehabilitation and secondary prevention inital assessment and individualised plan (recorded in hospital CR database).
Timepoint [1] 288787 0
at 2 weeks post discharge
Primary outcome [2] 288788 0
Proportion of patients receiving follow up at 3 months post ACS event to assess clinical management plan in place.
Hospital databases and patient self report utlised.
Timepoint [2] 288788 0
at 3 months post discharge
Primary outcome [3] 288789 0
Cost effectiveness of CR post ACS admission. Hospital and staff costs measured using hospital databases.
Timepoint [3] 288789 0
12 months
Secondary outcome [1] 300993 0
Number of hospital readmssions from hospital records
Timepoint [1] 300993 0
12 months
Secondary outcome [2] 301045 0
mortality rates
Timepoint [2] 301045 0
at 12 months

Eligibility
Key inclusion criteria
hospital diagnosis of Acute Coronary Syndrome defined by ICD 10 codes 120 and 121
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil groups excluded, assessment on individual basis

Study design
Purpose of the study
Prevention
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
540
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 531 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 6271 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 286678 0
Government body
Name [1] 286678 0
State Health Research Advisory Council
Country [1] 286678 0
Australia
Primary sponsor type
Individual
Name
Andrew Maiorana
Address
Royal Perth Hospital, Exercise physiology department Cardiac Transplant, Wellington St, Perth, WA, 6000
Country
Australia
Secondary sponsor category [1] 285453 0
Individual
Name [1] 285453 0
Julie Smith
Address [1] 285453 0
Cardiac Rehabilitation, Royal Perth Hospital , Wellington St, Perth, WA, 6000
Country [1] 285453 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288746 0
Royal Perth Hospital
Ethics committee address [1] 288746 0
Wellington St, Perth , WA, 6000
Ethics committee country [1] 288746 0
Australia
Date submitted for ethics approval [1] 288746 0
Approval date [1] 288746 0
23/10/2012
Ethics approval number [1] 288746 0
Ref: EC 2012/165

Summary
Brief summary
ACS patients discharged from RPH from 1st April 2011- 31st March 2012 will be compared to those discharged 1st April 2013- 31st March 2014 . The study will compare 2 models of cardiac rehabilitation: traditional cardiac rehabilitation vs a new alternative model implemented in April 2013. The proportion that access cardiac rehabilitation and secondary prevention programs plus cost effectiveness will be compared. Cardiac rehabilitation is defined as having an initial assessment and individualised plan within 2 weeks , education, and follow up at 3 months. Between April 2012 - March 2013 changes to referral processes and RPH cardiac rehabilitation program delivery were implemented using information sought from staff and patient surveys and focus groups. The study will compare readmssion rates and mortality of both ACS cohorts at 12 months after discharge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37610 0
Dr Andrew Maiorana
Address 37610 0
Royal Perth Hospital, Advanced heart failure and cardiac transplant Service, Wellington St,
Perth, WA, 6000
Country 37610 0
Australia
Phone 37610 0
+61 (0)433567369
Fax 37610 0
Email 37610 0
[email protected]
Contact person for public queries
Name 37611 0
Mrs Julie Smith
Address 37611 0
Royal Perth Hospital, Wellington St,
Perth, WA, 6000
Country 37611 0
Australia
Phone 37611 0
+61 (0)411137461
Fax 37611 0
Email 37611 0
[email protected]
Contact person for scientific queries
Name 37612 0
Dr Andrew Maiorana
Address 37612 0
Royal Perth Hospital, Advanced heart failure and cardiac transplant Service, Wellington St,
Perth, WA, 6000
Country 37612 0
Australia
Phone 37612 0
+61 (0)433567369
Fax 37612 0
Email 37612 0
[email protected]

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
EmbaseThe Development of a New Cardiac Rehabilitation Needs Assessment Tool (CRNAT) for Individualised Secondary Prevention.2015https://dx.doi.org/10.1016/j.hlc.2015.01.001
N.B. These documents automatically identified may not have been verified by the study sponsor.