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Trial registered on ANZCTR


Registration number
ACTRN12608000209392
Ethics application status
Approved
Date submitted
9/04/2008
Date registered
18/04/2008
Date last updated
25/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute myocardial infarction: investigating evidence-based practice to address the rural disadvantage.
Scientific title
The impact of clinical pathways on acute myocardial infarction management in rural hospitals.
Secondary ID [1] 252103 0
Impact of clinical pathways on time to thrombolysis in rural hospitals.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute myocardial infarction 3024 0
Condition category
Condition code
Cardiovascular 3174 3174 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A five step process over 3 months of implementing clinical pathways for AMI management in rural emergency departments.
The intervention sites will participate in the 5 step evidence-based implementation process described below. The control group will receive a hard copy of the relevant NHF guidelines. The evidence-based 5 step intervention within emergency departments to implement clinical pathways will be a combination of processes proposed by Doherty and Jones (2006) and Kinsman et al. (2007). In brief, the three month implementation process involves:
(b) Engaging clinicians
Group discussions will be held with medical and nursing staff regarding barriers and facilitators for clinical pathways whilst local clinicians will be recruited as Research Assistants. This role will involve activities such as participating in the clinical pathway development, as described below, and promoting the study amongst other staff members.
(c) Clinical pathway development
Hospital-specific clinical pathways will be developed collaboratively at each emergency department.
(d) Reminders
Reminder visits will occur twice following implementation to liaise with staff. Research Assistants will also be asked to remind medical and nursing staff about the clinical pathway.
(e) Education
Education sessions will be held during implementation to review evidence underpinning the clinical pathway. All staff will receive written material regarding thrombolytic drugs.
(f) Audit and feedback
Audit results reflecting compliance with the clinical pathway and thrombolysis administration will be communicated to staff twice during the implementation of the clinical pathway.
Intervention code [1] 2765 0
Other interventions
Comparator / control treatment
Distribution of clinical guidelines without implementation of clinical pathways.
Control group
Historical

Outcomes
Primary outcome [1] 4060 0
Proportion of eligible patients receiving a thrombolytic drug.
Timepoint [1] 4060 0
During treatment in the emergency department.
Door-to-needle time for thrombolysis.
Secondary outcome [1] 6832 0
Adherence to clinical pathway via the RE-AIM framework.
Timepoint [1] 6832 0
During emergency department treatment.

Eligibility
Key inclusion criteria
AMI patients meeting criteria for delivery of thrombolytic drugs.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
AMI not primary diagnosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Six hospitals involved - three will be randomised to intervention and three to control. Randomisation of hospitals to intervention or control will be the result of a coin toss conducted by the research team off-site and concealed from the study sites.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by coin-tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Cluster trial.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 818 0
3350
Recruitment postcode(s) [2] 815 0
3500
Recruitment postcode(s) [3] 814 0
3550
Recruitment postcode(s) [4] 817 0
3564
Recruitment postcode(s) [5] 816 0
3630

Funding & Sponsors
Funding source category [1] 3279 0
University
Name [1] 3279 0
Faculty of Medicine, Nursing and Health Sciences
Address [1] 3279 0
Monash University
VIC 3800
Country [1] 3279 0
Australia
Primary sponsor type
University
Name
Faculty of Medicine, Nursing and Health Sciences
Address
Monash University VIC 3800
Country
Australia
Secondary sponsor category [1] 2931 0
None
Name [1] 2931 0
Address [1] 2931 0
Country [1] 2931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5266 0
Monash University
Ethics committee address [1] 5266 0
Monash University
VIC 3800
Ethics committee country [1] 5266 0
Australia
Date submitted for ethics approval [1] 5266 0
14/03/2008
Approval date [1] 5266 0
02/04/2008
Ethics approval number [1] 5266 0
CF08/0532 - 2008000253

Summary
Brief summary
Background
People living in rural Australia are more likely to die in hospital following an acute myocardial infarction (AMI i.e. “heart attack”) than people in major cities (Moon & Phillips 2007). This disparity is partly due to lower uptake of National Heart Foundation (NHF) guidelines for the administration of thrombolytic drugs. One-third of eligible patients in rural areas do not receive this life-saving intervention (Kinsman et al. 2007). Clinical pathways are structured, locally developed multidisciplinary care plans for specific clinical problems that take into account local resources and availability of doctors. They are an important tool for linking evidence to practice and can enhance adherence to guidelines for use of thrombolytic drugs (Campbell et al.1998). Given that outcomes after AMI in rural settings are poor and that clinical pathways can improve outcomes this study trialled an evidence-based clinical pathway implementation process and its impact on AMI treatment in rural hospitals.
Participants
Six Victorian rural hospitals participated. Pairs of hospitals were matched according to the anticipated number of eligible patients and randomly allocated to either the intervention (n=3) or control (n=3) sites.
Method
The intervention sites participated in a 6 month implementation process. The 5 step evidence-based intervention involved: (1) Engaging clinicians, (2) Clinical pathway development, (3) Reminders, (4) Education, and (5) Audit and feedback. The control group received hard copies of the relevant NHF guidelines. Medical records of all patients diagnosed with AMI attending the 6 hospitals during the study period were identified using International Statistical Classification of Diseases (ICD-10) codes. The records were then audited using a standardised data protocol (approximate total of 600 records across 6 sites). Data included type of AMI, gender, and age. The audit also checked whether criteria for use of a thrombolytic drug were met, and if so, whether one was administered and the time in minutes from presentation to administration.
Results
The implementation of the clinical pathway had no impact on process measures.
Conclusion
Interventions to narrow the evidence-practice gap for the management of chest pain in rural settings require further evaluation if the gap in outcomes between rural and urban settings is to be reduced.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28511 0
Address 28511 0
Country 28511 0
Phone 28511 0
Fax 28511 0
Email 28511 0
Contact person for public queries
Name 11668 0
Leigh Kinsman
Address 11668 0
School of Rural Health
Monash University
PO Box 666
Bendigo VIC 3552
Country 11668 0
Australia
Phone 11668 0
61354409022
Fax 11668 0
61354409080
Email 11668 0
leigh.kinsman@monash.edu
Contact person for scientific queries
Name 2596 0
Leigh Kinsman
Address 2596 0
Monash University
PO Box 666
Bendigo VIC 3552
Country 2596 0
Australia
Phone 2596 0
61354409022
Fax 2596 0
61354409080
Email 2596 0
leigh.kinsman@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary