Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.

Conditions
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Acute Coronary Syndrome, Myocardial Infarction, Acute

Intervention / Treatment
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* Other: Community education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult residents of the eight local government areas - Exclusion Criteria: Adults not residing in the eight local government areas. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention period with active Heart Matters education delivered | Other: Community education<br>* Heart Matters coordinators will deliver heart health education to the community using HM materials and Partner resources.<br>* Other names: Local campaign;|
| No Intervention: Control<br>Control period with no Heart Matters education delivered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulance use for ACS | The proportion of ACS patients that present to ED by ambulance. | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median ACS patient delay time | The median ACS patients delay time (time from symptom onset to decision to seek medical attention). | 16 months | 
| ACS patient delay time <60 minutes | The proportion of ACS patients with patient delay times <60 minutes | 16 months | 
| Median ACS patient prehospital delay time | The median ACS patient prehospital delay time (time from symptom onset to arrival at hospital). | 16 months | 
| ACS patients prehospital delay times <120 minutes | The proportion of ACS patients with prehospital delay times <120 minutes | 16 months | 
| Awareness of own risk of heart attack | The proportion of adult members of the community who are aware of their own risk of heart attack. | 0-2 months and 6-8 months | 
| Awareness of heart attack as a leading cause of death | The proportion of adult members of the community who identify heart disease a leading cause of death | 0-2 months and 6-8 months | 
| Awareness of heart attack risk factors | The proportion of adult members of the community who identify cardiovascular risk factors | 0-2 months and 6-8 months | 
| Number of correctly named heart attack risk factors | The number of correctly named cardiovascular risk factors by adult members of the community | 0-2 months and 6-8 months | 
| Awareness of heart attack signs and symptoms | The proportion of adult members of the community aware of heart attack symptoms | 0-2 months and 6-8 months | 
| Number of correctly named heart attack signs and symptoms | The number of correctly named ACS symptoms by adult members of the community | 0-2 months and 6-8 months | 
| Confidence in knowing how to act | The proportion adult members of the community who are confident about what they would do if experiencing a heart attack | 0-2 months and 6-8 months | 
| Ambulance use in scenarios | The proportion adult members of the community who correctly state they would call an ambulance for two heart attack scenarios. | 0-2 months and 6-8 months | 
| Rates of Heart Health Checks | Rates of Medicare claims for General Practitioner (GP) Heart Health Checks | 16 months | 
| Rates of ACS ED presentations | The rates of ED presentations that are ACS | 16 months | 
| Rates of unspecified chest pain ED presentations | Rates of ED presentations that are unspecified chest pain | 16 months | 
| ACS ED presentations via GPs | Proportion of ACS ED presentations via General Practitioners | 16 months | 
| Rates of ACS survival | The proportion of ACS patients surviving to hospital discharge | 16 months | 
| Incidence of OHCA | incidence of out-of-hospital cardiac arrest | 16 months | 
| Rates of OHCA | Rates out-of-hospital cardiac arrest survival | 16 months | 
| Calls to ambulance for chest pain | Proportion of chest pain (event type 10) calls to ambulance | 16 months | 
| Calls to ambulance for non- chest pain | Proportion of non-chest pain emergency calls to ambulance | 16 months |