Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Monash University
- Enrollment
- 2,240
- Locations
- 1
- Primary Endpoint
- Ambulance use for ACS
Study Overview
Brief Summary
The aim of the study is to evaluate whether providing a targeted heart health education campaign to regions at high risk of heart attacks will improve ACS patient's symptom recognition and response.
The intervention will be will be evaluated according to a cluster randomized, stepped wedged design. The clusters are eight local government areas (LGAs) in Victoria, Australia. The main primary outcome will be assessed in consecutive patients presenting to emergency departments from the six LGAs throughout the study period with an ED diagnoses of acute coronary syndrome.
Detailed Description
Primary objectives:
To determine if targeted heart health education will:
- Increase ambulance use in ACS patients (main primary outcome);
- Decrease patient and prehospital delay times in ACS patients;
- Increase awareness of personal cardiovascular risk and associated factors in adult community members; and
- Increase cardiovascular knowledge and confidence to act to heart attack warning signs in adult community members.
Secondary objectives
- To determine if targeted heart health education:
- Reduces the incidence of out-of-hospital cardiac arrest;
- Improves survival in OHCA patients;
- Improves survival in ACS patients;
- Improves survival and ACS patients;
- Increases presentations to ED for ACS and unspecified chest pain; and
- Increases the rates of calls to ambulance for chest pain and non-chest pain.
- Increases the rate of Heart Health Checks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes are collected blinded to the study allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult residents of the eight local government areas -
Exclusion Criteria
- •Adults not residing in the eight local government areas.
Arms & Interventions
Intervention
Intervention period with active Heart Matters education delivered
Intervention: Community education (Other)
Control
Control period with no Heart Matters education delivered.
Outcomes
Primary Outcomes
Ambulance use for ACS
Time Frame: 16 months
The proportion of ACS patients that present to ED by ambulance.
Secondary Outcomes
- Number of correctly named heart attack risk factors(0-2 months and 6-8 months)
- ACS patients prehospital delay times <120 minutes(16 months)
- Median ACS patient delay time(16 months)
- ACS patient delay time <60 minutes(16 months)
- Awareness of heart attack signs and symptoms(0-2 months and 6-8 months)
- Rates of Heart Health Checks(16 months)
- ACS ED presentations via GPs(16 months)
- Rates of ACS survival(16 months)
- Median ACS patient prehospital delay time(16 months)
- Awareness of own risk of heart attack(0-2 months and 6-8 months)
- Awareness of heart attack risk factors(0-2 months and 6-8 months)
- Confidence in knowing how to act(0-2 months and 6-8 months)
- Ambulance use in scenarios(0-2 months and 6-8 months)
- Rates of unspecified chest pain ED presentations(16 months)
- Rates of OHCA(16 months)
- Calls to ambulance for chest pain(16 months)
- Awareness of heart attack as a leading cause of death(0-2 months and 6-8 months)
- Number of correctly named heart attack signs and symptoms(0-2 months and 6-8 months)
- Rates of ACS ED presentations(16 months)
- Calls to ambulance for non- chest pain(16 months)
- Incidence of OHCA(16 months)
Investigators
Janet
Associate Professor
Monash University