Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000381381
Ethics application status
Approved
Date submitted
14/08/2014
Date registered
14/03/2017
Date last updated
14/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving Care Processes for Patients with Possible Acute Coronary Syndrome
Scientific title
An accelerated diagnostic pathway for ruling out Acute Coronary Syndrome in patients presenting to the Emergency Department with chest pain: does this improve rates of safe (no increase in MACE) discharge within 6 hours.
Secondary ID [1] 285098 0
NIL
Universal Trial Number (UTN)
U1111-1159-9891
Trial acronym
ICare-ACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 292652 0
Acute Myocardial Infarction
 292686 0
Condition category
Condition code
Cardiovascular 292963 292963 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an audit of a change of practice mandated by the Ministry of Health to implement an accelerated chest pain pathway for suspected Ischaemic Heart Disease into New Zealand hospitals, requiring reliable and consistent retrospective collection of chest pain data. Each of the eight hospitals will have control period of 6 months prior to the implementation of the accelerated pathway and a minimum of 4 months of cases following the implementation. Implementation will begin in each of the eight sites in a staggered fashion (1 month apart). The total data collection time, including a 30 day follow up, will be 18 months.
Each site will determine its own accelerated pathway based on current evidence and local conditions. This will comprise biochemistry (a 0h high sensitive troponin I or T, and a 2 or 3 hour second high sensitive troponin, ECG, and a risk evaluation with an appropriate scoring system with a decision point for assigning to low risk and therefore eligible for early discharge). Sites vary in practice at the moment. For most sites this will mean measuring an earlier time point second troponin, and implementation of a scoring system not currently implemented.
Intervention code [1] 289947 0
Not applicable
Comparator / control treatment
This study is an audit the implementation of an accelerated chest pain pathway for suspected Ischaemic Heart Disease. Each site is its own control (6 months prior to the implementation of the pathway). Current practice varies between sites. In all sites a high sensitive troponin (T or I) is measured on entry to the ED, along with an ECG, a patient history is compiled. Beyond this, sites vary with the timing of a second troponin and the use of a risk assessment scoring system. Clinical judgment rather than structured methodology to assess for Low Risk is used.
Control group
Historical

Outcomes
Primary outcome [1] 292820 0
Assessment of service delivery: The proportion of patients “successfully” discharged home within 6 hours of ED arrival. A successful discharge is one with no major adverse cardiac event (MACE) during the following 30 days
Timepoint [1] 292820 0
By 31 March 2015 data will have been collected from the proposed pilot sites. Analysis of patient 30 day follow-up data (for MACE outcomes) will then allow improvements to service delivery before implementation of the new pathway across all district health boards.
Secondary outcome [1] 310030 0
The ratio of patients with two troponin measurements within 24 hours compared to one.
Timepoint [1] 310030 0
Troponin measurements on individual patients within 24 hours of ED presentation
Secondary outcome [2] 310031 0
Subjective analysis of lessons learnt of the implementation of the new pathway based on semistructured interviews with staff and informal feedback to study authors
Timepoint [2] 310031 0
This will be completed by the study end. It is intended to be an assessment of common barriers and solutions to the change of practice which be made available to non-participating hospitals which are also undergoing a change of practice.

Eligibility
Key inclusion criteria
Adults (greater than or equal to 18 years of age), Serial troponin testing for possible cardiac disease as indicated by a cardiac troponin test performed during initial assessment in the ED with a 2nd test performed within 24 hours of attendance.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A clear non-coronary cause of chest pain, Domiciled overseas.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Successful discharge (without the occurrence of MACE) will be compared between control and intervention arms using a Mantel-Haenszel test for stratified data. Given 5-10% of ED presentations are for Chest Pain, and an annual ED presentation of over 360,000 patients, we expect between 9,000 and 18,000 patients in the control arm and 11,000 to 22,000 in the intervention arm (average duration of intervention is 7.5 months). In the Christchurch randomised control trial of a Modified TIMI score successful discharge occurred in 19.3% compared with 11% in the control pathway (8.3% absolute difference). If we assume a similar control group rate of successful early discharge (11%), then, conservatively, 9,000 patients in the control arm and 11,000 in the intervention arm will allow detection of an absolute difference of 1.5% at an alpha of 0.05 and with 90% power. We expect even such a small difference will have beneficial health outcomes and economic effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/04/2014
Date of last participant enrolment
Anticipated
Actual
31/12/2015
Date of last data collection
Anticipated
Actual
31/01/2016
Sample size
Target
30000
Accrual to date
Final
31332
Recruitment outside Australia
Country [1] 6269 0
New Zealand
State/province [1] 6269 0

Funding & Sponsors
Funding source category [1] 289706 0
Government body
Name [1] 289706 0
Health Research Council of New Zealand
Country [1] 289706 0
New Zealand
Primary sponsor type
Individual
Name
Dr Martin Than
Address
Canterbury District Health Board and Emergency Care Foundation
c/- 21 Taylors Mistake Road
Sumner
Christchurch 8081
Country
New Zealand
Secondary sponsor category [1] 288403 0
Individual
Name [1] 288403 0
Associate Professor John Pickering
Address [1] 288403 0
c/- Emergency Care Foundation
P O Box 13-149
Christchurch 8141
Country [1] 288403 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291446 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 291446 0
Ethics committee country [1] 291446 0
New Zealand
Date submitted for ethics approval [1] 291446 0
30/07/2014
Approval date [1] 291446 0
31/07/2014
Ethics approval number [1] 291446 0
14/NTB/107

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 150 150 0 0
/AnzctrAttachments/366841-Protocol for ICARE-ACS v 1.0 140728.pdf
Attachments [2] 151 151 0 0
/AnzctrAttachments/366841-HDEC_Letter_-_14NTB107_-_Out_of_Scope_Application.pdf

Contacts
Principal investigator
Name 50422 0
Dr Martin Than
Address 50422 0
Canterbury District Health Board and Emergency Care Foundation
21 Taylors Mistake Road
Sumner
Christchurch 8081
Country 50422 0
New Zealand
Phone 50422 0
+64 3 326 7599
Fax 50422 0
Email 50422 0
[email protected]
Contact person for public queries
Name 50423 0
Martin Than
Address 50423 0
c/- Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 50423 0
New Zealand
Phone 50423 0
+64 3 3640 640
Fax 50423 0
Email 50423 0
[email protected]
Contact person for scientific queries
Name 50424 0
John Pickering
Address 50424 0
c/- Emergency Care Foundation
P O Box 13-149
Christchurch 8140
Country 50424 0
New Zealand
Phone 50424 0
+64 21 253 7877
Fax 50424 0
Email 50424 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.