TY - JOUR
T1 - A protocol for the Heart Matters stepped wedge cluster randomised trial
T2 - The effectiveness of heart attack education in regions at highest-risk
AU - Bray, Janet E.
AU - Nehme, Ziad
AU - Finn, Judith C.
AU - Kasza, Jessica
AU - Clark, Robyn A.
AU - Stub, Dion
AU - Cadilhac, Dominique A.
AU - Buttery, Amanda K.
AU - Woods, Janelle
AU - Kim, Joosup
AU - Smith, Ben J.
AU - Smith, Karen
AU - Cartledge, Susie
AU - Beauchamp, Alison
AU - Dodge, Natasha
AU - Walker, Tony
AU - Flemming-Judge, Elizabeth
AU - Chow, Clara
AU - Stewart, Mary
AU - Cox, Nicholas
AU - van Gaal, William
AU - Nadurata, Voltaire
AU - Cameron, Peter
N1 - Funding Information:
This work was supported by funding from a National Health and Medical Research Council (NHMRC) Partnership Grant ( GTN 1180282 ) in partnership with the Heart Foundation of Australia, Ambulance Victoria, and the Victorian Government Department of Health . JB (#104751) , ZN (#105690) , DS (#105793) and SC (#104860) are supported by Heart Foundation Fellowships . CC (#1195326) , DS (#105793) , DC (#1154273) , ABe (#1198006) and JF (#1174838) are supported by NHMRC Investigator Grants. PC receives a Medical Research Future Fund Fellowship (#1139686) . The trial sponsor is Monash University. Neither the funding body nor the sponsor had any role in the design of this study and will not have any role during its execution, data collection and management, analyses and interpretation of the data, writing of reports or decision to submit results for publications.
Funding Information:
We thank Stephen Ball (Curtin University) for his assistance with the randomisation. We thank partner staff who contributed to the study development: Adam Stormont, Elizabeth Sinclair, Kellie-Ann Jolly, Roni Beauchamp, Arthur Nasis, and Kelly Donnelly. JB conceived the initial study design and drafted the protocol submitted to the National Health and Medical Research Council with contributions from all investigators (nine chief investigators and ten associate investigators) and three partner investigators listed in the grant application. JeK conducted the sample size calculation and drafted the statistical plan. DC and JoK drafted the economic evaluation plan. JW designed the community engagement and is managing the project. JB drafted the manuscript, and all other authors contributed to the revisions and approved the final version. Data access is restricted to the Principal Investigator, the economic analysts, and the study statisticians. Contractual agreements for data provision do not allow for the sharing of data. This work was supported by funding from a National Health and Medical Research Council (NHMRC) Partnership Grant (GTN 1180282) in partnership with the Heart Foundation of Australia, Ambulance Victoria, and the Victorian Government Department of Health. JB (#104751), ZN (#105690), DS (#105793) and SC (#104860) are supported by Heart Foundation Fellowships. CC (#1195326), DS (#105793), DC (#1154273), ABe (#1198006) and JF (#1174838) are supported by NHMRC Investigator Grants. PC receives a Medical Research Future Fund Fellowship (#1139686). The trial sponsor is Monash University. Neither the funding body nor the sponsor had any role in the design of this study and will not have any role during its execution, data collection and management, analyses and interpretation of the data, writing of reports or decision to submit results for publications.
Publisher Copyright:
© 2023 The Author(s)
PY - 2023/9
Y1 - 2023/9
N2 - Aim: To describe the Heart Matters (HM) trial which aims to evaluate the effectiveness of a community heart attack education intervention in high-risk areas in Victoria, Australia. These local government areas (LGAs) have high rates of acute coronary syndrome (ACS), out-of-hospital cardiac arrest (OHCA), cardiovascular risk factors, and low rates of emergency medical service (EMS) use for ACS. Methods: The trial follows a stepped-wedge cluster randomised design, with eight clusters (high-risk LGAs) randomly assigned to transition from control to intervention every four months. Two pairs of LGAs will transition simultaneously due to their proximity. The intervention consists of a heart attack education program delivered by trained HM Coordinators, with additional support from opportunistic media and a geo-targeted social media campaign. The primary outcome measure is the proportion of residents from the eight LGAs who present to emergency departments by EMS during an ACS event. Secondary outcomes include prehospital delay time, rates of OHCA and heart attack awareness. The primary and secondary outcomes will be analysed at the patient/participant level using mixed-effects logistic regression models. A detailed program evaluation is also being conducted. The trial was registered on August 9, 2021 (NCT04995900). Results: The intervention was implemented between February 2022 and March 2023, and outcome data will be collected from administrative databases, registries, and surveys. Primary trial data is expected to be locked for analysis by October 31st 2023, with a follow-up planned until March 31st 2024. Conclusion: The results from this trial will provide high-level evidence the effectiveness of a community education intervention targeting regions at highest-risk of ACS and low EMS use.
AB - Aim: To describe the Heart Matters (HM) trial which aims to evaluate the effectiveness of a community heart attack education intervention in high-risk areas in Victoria, Australia. These local government areas (LGAs) have high rates of acute coronary syndrome (ACS), out-of-hospital cardiac arrest (OHCA), cardiovascular risk factors, and low rates of emergency medical service (EMS) use for ACS. Methods: The trial follows a stepped-wedge cluster randomised design, with eight clusters (high-risk LGAs) randomly assigned to transition from control to intervention every four months. Two pairs of LGAs will transition simultaneously due to their proximity. The intervention consists of a heart attack education program delivered by trained HM Coordinators, with additional support from opportunistic media and a geo-targeted social media campaign. The primary outcome measure is the proportion of residents from the eight LGAs who present to emergency departments by EMS during an ACS event. Secondary outcomes include prehospital delay time, rates of OHCA and heart attack awareness. The primary and secondary outcomes will be analysed at the patient/participant level using mixed-effects logistic regression models. A detailed program evaluation is also being conducted. The trial was registered on August 9, 2021 (NCT04995900). Results: The intervention was implemented between February 2022 and March 2023, and outcome data will be collected from administrative databases, registries, and surveys. Primary trial data is expected to be locked for analysis by October 31st 2023, with a follow-up planned until March 31st 2024. Conclusion: The results from this trial will provide high-level evidence the effectiveness of a community education intervention targeting regions at highest-risk of ACS and low EMS use.
KW - Acute coronary syndrome
KW - Cardiovascular disease
KW - Community education
KW - Emergency medical services
KW - Health promotion
KW - Myocardial infarction
KW - Step-wedged design
UR - http://www.scopus.com/inward/record.url?scp=85165624006&partnerID=8YFLogxK
U2 - 10.1016/j.resplu.2023.100431
DO - 10.1016/j.resplu.2023.100431
M3 - Article
C2 - 37555197
AN - SCOPUS:85165624006
SN - 2666-5204
VL - 15
JO - Resuscitation Plus
JF - Resuscitation Plus
M1 - 100431
ER -
