Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000470998
Ethics application status
Approved
Date submitted
1/05/2011
Date registered
6/05/2011
Date last updated
6/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Streamlining follow up of intermediate risk chest pain presentations: Does pre-organised early stress testing improve compliance to guidelines and 30-day outcomes?
Scientific title
In patients discharged from the emergency department with intermediate risk acute coronary syndrome, does pre-organised appointments for early stress testing improve compliance with current guidelines and 30 day outcomes compared with patients who were asked to organise their own appointments.
Secondary ID [1] 260085 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intermediate risk of non-ST-elevation acute coronary syndrome 265759 0
Condition category
Condition code
Cardiovascular 265906 265906 0 0
Coronary heart disease
Public Health 265952 265952 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Evaluating the rate of attendance for follow up exercise stress testing in patients who were given pre-organised appointment times.
Evaluating the representation rate with cardiac related chest pain, adverse cardiac events, coronary intervention procedures and mortality over 30 days following their discharge.
Intervention code [1] 264502 0
Not applicable
Comparator / control treatment
Historical control group: this group of patients are patients who have been discharged with the same inclusion criteria as the experimental group but were not given pre-organised appointment times. Rather they were asked to make their own appointment or contact their general practitioner for a referral for exercise stress testing. The control group have been selected from patients meeting the inclusion criteria between January 2010 to June 2010 from the same hospital (Armadale Health Services)
Control group
Historical

Outcomes
Primary outcome [1] 266671 0
To determine whether providing patients with pre-organised appointment times increases their compliance to return for exercise stress testing.
Timepoint [1] 266671 0
Follow up will occur at day 30 post discharge from the emergency department in order to evaluate their compliance with attending exercise stress testing
Secondary outcome [1] 276164 0
To determine the 30 day mortality rate of patients discharged with a diagnosis of intermediate risk ACS.
Timepoint [1] 276164 0
Day 30 post discharge from the emergency department
Secondary outcome [2] 276165 0
To determine the likelihood of major adverse cardiac events in patient who returned for EST compared to those who did not.
Major adverse cardiac events include ST-elevation myocardial infarcts, angioplasty/stent, Coronary Artery Bypass Grafting (CABG), stable and unstable angina.
This outcome will be assessed by collecting data from health department databases and software and performing telephone interviews with patients.
Timepoint [2] 276165 0
Day 30 post discharge from the emergency department
Secondary outcome [3] 276166 0
To determine what barriers prevent patients from attending follow up EST.
This outcome will be assessed with telephone interviews and questionnaire.
Timepoint [3] 276166 0
Day 30 post discharge from the emergency department
Secondary outcome [4] 276167 0
To determine the patients' perceived risk of future cardiac events compared to their actual risk determined by the guidelines set out by the National Heart Foundation/Cardiac Society of Australia and New Zealand.
The patient will be asked to perform a questionnaire over the telephone that will address their perceived risk on an alphabetical scale. (ie A) 1-2%, B) 3-4% etc)
Timepoint [4] 276167 0
Day 30 post discharge from the emergency department

Eligibility
Key inclusion criteria
>18 yo and informed consent obtained, discharged from emergency department with intermediate risk acute coronary syndrome, suitable for exercise threadmill stress testing, able to follow up patient via telephone at 30 days.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, contraindications to stress testing, <18 yo or >75 yo, cognitively impaired, inability to consent, inability to follow up patient (overseas visitor or no telephone access)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264988 0
Self funded/Unfunded
Name [1] 264988 0
Nil
Country [1] 264988 0
Primary sponsor type
Individual
Name
A/Prof David Playford
Address
Suite 10, Armadale Hospital Specialist Centre,
3056 Albany Hwy, Armadale
Western Australia 6112
Country
Australia
Secondary sponsor category [1] 264074 0
None
Name [1] 264074 0
Nil
Address [1] 264074 0
Nil
Country [1] 264074 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266943 0
South Metropolitan Area Health Services
Ethics committee address [1] 266943 0
Ethics committee country [1] 266943 0
Australia
Date submitted for ethics approval [1] 266943 0
01/04/2011
Approval date [1] 266943 0
18/04/2011
Ethics approval number [1] 266943 0
11/76

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

Contacts
Principal investigator
Name 32552 0
Address 32552 0
Country 32552 0
Phone 32552 0
Fax 32552 0
Email 32552 0
Contact person for public queries
Name 15799 0
KEVIN CHUNG
Address 15799 0
The University of Notre Dame
School of Medicine, Fremantle
PO Box 1225
FREMANTLE
WESTERN AUSTRALIA 6959
Country 15799 0
Australia
Phone 15799 0
+61(0)401137838
Fax 15799 0
Email 15799 0
[email protected]
Contact person for scientific queries
Name 6727 0
KEVIN CHUNG
Address 6727 0
The University of Notre Dame
School of Medicine, Fremantle
PO Box 1225
FREMANTLE
WESTERN AUSTRALIA 6959
Country 6727 0
Australia
Phone 6727 0
+61(0)401137838
Fax 6727 0
Email 6727 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
No additional documents have been identified.