Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.
- Conditions
- Acute Coronary SyndromeMyocardial Infarction, Acute
- Interventions
- Other: Community education
- Registration Number
- NCT04995900
- Lead Sponsor
- Monash University
- 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:
1. Increase ambulance use in ACS patients (main primary outcome);
2. Decrease patient and prehospital delay times in ACS patients;
3. Increase awareness of personal cardiovascular risk and associated factors in adult community members; and
4. Increase cardiovascular knowledge and confidence to act to heart attack warning signs in adult community members.
Secondary objectives
1. To determine if targeted heart health education:
2. Reduces the incidence of out-of-hospital cardiac arrest;
3. Improves survival in OHCA patients;
4. Improves survival in ACS patients;
5. Improves survival and ACS patients;
6. Increases presentations to ED for ACS and unspecified chest pain; and
7. Increases the rates of calls to ambulance for chest pain and non-chest pain.
8. Increases the rate of Heart Health Checks.
Intervention: To meet the objectives of the study, we will employ HM coordinators for each of the eight high-risk LGAs to organise and deliver our HM education program using HM materials and Partner resources.
Design: The stepped-wedge design is a uni-directional cross-over design - where the randomisation element is when the cluster crosses-over to the intervention following a control period.
Over the 16-month study period, the eight LGAs will move into the intervention phase at two month intervals. As four LGAs are in close proximity, these LGAs will switch from control to intervention periods at the same time to avoid possible contamination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2240
Adult residents of the eight local government areas -
Adults not residing in the eight local government areas.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention Community education Intervention period with active Heart Matters education delivered
- Primary Outcome Measures
Name Time Method Ambulance use for ACS 16 months The proportion of ACS patients that present to ED by ambulance.
- Secondary Outcome Measures
Name Time Method ACS patients prehospital delay times <120 minutes 16 months The proportion of ACS patients with prehospital delay times \<120 minutes
Median ACS patient delay time 16 months The median ACS patients delay time (time from symptom onset to decision to seek medical attention).
ACS patient delay time <60 minutes 16 months The proportion of ACS patients with patient delay times \<60 minutes
Number of correctly named heart attack risk factors 0-2 months and 6-8 months The number of correctly named cardiovascular risk factors by adult members of the community
Awareness of heart attack signs and symptoms 0-2 months and 6-8 months The proportion of adult members of the community aware of heart attack symptoms
Rates of Heart Health Checks 16 months Rates of Medicare claims for General Practitioner (GP) Heart Health Checks
ACS ED presentations via GPs 16 months Proportion of ACS ED presentations via General Practitioners
Rates of ACS survival 16 months The proportion of ACS patients surviving to hospital discharge
Median ACS patient prehospital delay time 16 months The median ACS patient prehospital delay time (time from symptom onset to arrival at hospital).
Awareness of own risk of heart attack 0-2 months and 6-8 months The proportion of adult members of the community who are aware of their own risk of heart attack.
Awareness of heart attack risk factors 0-2 months and 6-8 months The proportion of adult members of the community who identify cardiovascular risk factors
Confidence in knowing how to act 0-2 months and 6-8 months The proportion adult members of the community who are confident about what they would do if experiencing a heart attack
Ambulance use in scenarios 0-2 months and 6-8 months The proportion adult members of the community who correctly state they would call an ambulance for two heart attack scenarios.
Rates of unspecified chest pain ED presentations 16 months Rates of ED presentations that are unspecified chest pain
Rates of OHCA 16 months Rates out-of-hospital cardiac arrest survival
Calls to ambulance for chest pain 16 months Proportion of chest pain (event type 10) calls to ambulance
Awareness of heart attack as a leading cause of death 0-2 months and 6-8 months The proportion of adult members of the community who identify heart disease a leading cause of death
Number of correctly named heart attack signs and symptoms 0-2 months and 6-8 months The number of correctly named ACS symptoms by adult members of the community
Rates of ACS ED presentations 16 months The rates of ED presentations that are ACS
Calls to ambulance for non- chest pain 16 months Proportion of non-chest pain emergency calls to ambulance
Incidence of OHCA 16 months incidence of out-of-hospital cardiac arrest
Trial Locations
- Locations (1)
Victorian LGAs
🇦🇺Melbourne, Please Select, Australia