Effect of an assisted self-management program to prevent new life-threatening events post heart attack

INTERVENTION: The SPAN intervention is a flexible framework for secondary prevention after a heart attack providing a minimum level of health service standardisation. It can be delivered across any health area service regardless of a patient’s age, gender, ethnicity, geographical location or socioeconomic position. Patients continue to receive their routine care, including usual pharmacotherapy and lifestyle advice at the discretion of their treating clinicians, whilst receiving the four preventative pillars of education, assessment, individual risk management planning, and supplementary follow‐up. Study materials will be adapted from earlier trials (CHOICE Trial Redfern et al, Heart 2008 Sydney University ANZAC Research Institute, Concord Hospital ISRCTN42984084; CHOICE+ Neubeck et al, HLC 2018, Sydney University, ANZAC Research Institute, Concord Hospital, ACTRN12608000182392) to reflect advances in remote monitoring and technology. Use of these resources and associated intensity is at the discretion of the participant. There is no pre‐specified template for the number or duration of sessions or the timing as to when they occur in the 12 weeks. The format of delivery is precision‐tailored content, with setting and method of contact depending on patient need, access, preference and goals. Each patient will work with a study trained secondary prevention health professional to develop a mutually agreed schedule of contacts, strategies and goals for their personal preventive care. This is bookended by induction ‐ mean 50 minutes ‐ and close‐out clinic visit/telephone calls ‐ mean 30 minutes. At induction, participants are familiarised with their modifiable risk factors for new events and the options available for management should they elect to do so. All baseline data for the study wi CONDITION: Cardiovascular ‐ Coronary heart disease Type 1 myocardial infarction; ; Type 1 myocardial infarction PRIMARY OUTCOME: Proportion of patients completing at least 80% of all scheduled sessions (yes/no) for standard outpatient rehabilitation versus SPAN. This will be extracted from either hard copy or electronic medical records documented as part of normal clinical responsibilities and from direct access to the personalised rehabilitation plan template and follow‐up case report form (CRF) kept by the secondary prevention coordinator, and assessed using a logistic regression analysis with stratification by site. [Median of 3 months follow‐up at the time of intervention completion. ] SECONDARY OUTCOME: Adherence to guideline indicated medications as assessed by data linkage to medical records.[Median of 12 months follow‐up assessed from the time of intervention commencement to 12 months post‐intervention commencement.] All‐cause death as assessed by data linkage to the National Health Index. [Median of 12 months follow‐up assessed from the time of intervention commencement to 12 months post‐intervention commencement.] Level of health service utilisation as assessed by data linkage to health service records.[Median of 12 months follow‐up assessed from the time of intervention commencement to 12 months post‐intervention commencement.] INCLUSION CRITERIA: Persons aged at least 18 years; Inpatient diagnosis of suspected ST‐segment elevation MI (STEMI), or high‐risk and intermediate‐risk non‐STEMI (NSTEMI) acute coronary syndrome by ACS Guidelines and 4th universal definition of MI. Specifically, Troponin Pattern 1 (Acute Myocardial Injury): A rise and/or fall in troponin from at least 2 samples defined as: (1) Hs‐Troponin T: A rise and/or fall in the absolute troponin level of >2.5ng/L/hour (ie a change of >15ng/L in 6 hours) between any troponin results before randomisation OR a relative change in troponin >20% between earlier and later samples (ie 100*(hs‐TnT[later] ‐ hs‐TnT[earlier] / hs‐TnT[earlier]) >20%) documented on any troponin results before randomisation. (2) Hs‐Troponin I: An absolute elevation of >10 times the upper limit of normal specific for that assay, using gender‐specific cut‐points if implemented locally OR change in troponin >20% between earlier and later samples (ie 100*(hs‐TnI[later] ‐ hs‐Tn