Clinical trial NCT02382731: Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction
Official title: Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Coronary Disease
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Population Health Research Institute
First posted: 2015-03-09
Enrollment: 2742
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Proven treatments exist that improve quality of life and reduce the risk of repeat heart attacks or death amongst persons who have already had one heart attack. These treatments include medications and supervised cardiac rehabilitation programs. Unfortunately, research shows that many people who have had a heart attack do not stick with these treatments and therefore cannot benefit. This quality improvement research program seeks to understand the impact of interventions that could be readily implemented at scale by entire health systems or organizations wishing to improve adherence to proven treatments. Specifically, the trial will test whether providing Ontario-based patients (and their health professionals) with repeated educational reminders delivered via post and phone will help improve the use of medications or attendance at cardiac rehabilitation. During the project, the types of patients who are most responsive will be identified as will the most cost-effective strategy for delivering reminders. The trial team are partnering in this project with health system decision makers who have an interest in using the results to create standard operating procedures that could benefit patients across the province.

Detailed description: EXECUTIVE SUMMARY

Background: In patients who have had a myocardial infarction (MI) and coronary disease, guidelines recommend cardiac rehabilitation services and the long-term use of cardiac medications to reduce the risk of recurrent cardiovascular events. Adherence to these recommendations substantially reduces morbidity and mortality post-MI. However, for a variety of patient, provider, and system-level reasons, adherence to cardiac medications declines to approximately 50% by 12 months. Likewise, only 30-40% of patients participate in cardiac rehabilitation. Thus, interventions to increase secondary prevention treatment adherence are urgently needed.

The Cardiac Care Network of Ontario (CCN) holds a registry of all patients in the province who have a coronary angiography. The registry has been used to identify gaps in care and to plan health system strategies for high-risk patients. More recently, a pilot trial was conducted in Hamilton by the trial team using data in the registry to send recurrent postal reminders regarding the importance of treatment adherence to patients, their pharmacists, and family physicians. A similar program is underway in Ottawa using automated phone calls with interactive voice response and nurse follow up. These interventions both have the potential to address known determinants of adherence. The CCN, Ministry of Health and Long-Term Care, Health Quality Ontario, and other stakeholders across Ontario are interested in evaluating the comparative effectiveness and costs of these interventions.

Research Questions: The research objectives were formed by the decision makers' need to evaluate whether and in what format to sustain and/or scale-up post-MI educational reminder interventions:

i. Can educational reminders delivered via post and/or using interactive voice response with personalized telephone follow up improve secondary prevention treatment adherence post-MI?

ii. How do different approaches to improve adherence to these recommendations compare in terms of clinical effectiveness and costs?

iii. Which subgroups are more/less likely to respond to reminders?

Research Approach: This is a pragmatic, randomized controlled trial with blinded outcome assessment. Patients in cardiac centres throughout Ontario who undergo a coronary angiography will be provided a letter of information explaining the study appended to the standard CCN letter of information. CCN will identify eligible patients (those with substantial coronary artery disease who survive their initial hospitalization post-MI) and provide the patient list back to the cardiac centre. A representative at the centre will securely send this list to the Population Health Research Institute in Hamilton. Patients will be randomized by the Population Health Research Institute team to one of three arms:

1. - Usual care, with no standardized educational materials or reminders
2. - Postal letters sent from Population Health Research Institute on behalf of each hospital's interventional cardiology team to the patient approximately 4, 8, 20, 32, and 44 weeks post-MI, with an insert for the family physician and pharmacist at approximately 4 and 8 weeks post-MI.
3. - Postal letters as above plus interactive voice response phone calls to the patient delivered approximately 2 weeks after the letters, as well as personalized telephone follow up by trained lay health workers for patients identified by the interactive voice response system as non-adherent.

Patient self-report and administrative data will be used to assess outcomes 12 months post-MI. Analyses will be by intention to treat. The primary outcome is adherence to guideline-recommended treatments. Secondary outcomes include health services utilization (including outpatient visits to interventional cardiology), recurrent cardiovascular events, and mortality. During the trial, a theory-informed process questionnaire will be administered to a random sub-sample. An economic evaluation will be conducted from the perspective of the public health care payer.

Implications: This project has the potential to lead to improvements in care for patients at high cardiovascular risk as well as provide generalizable insights regarding how to optimize interventions to improve adherence. Further, it has the potential to inform how other health databases could be used to improve health system performance.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and older having a coronary angiography following a myocardial infarction (ST-elevation myocardial infarction or non-ST-elevation myocardial infarction), with evidence of coronary artery disease (\>50% blockage of left main or \>70% blockage of ≥1 major cardiac arteries).
* Discharged from the catheterization centre alive, either home or to a local (non-cardiac) hospital
* Patients must be Ontario residents

Exclusion Criteria:

* Patients will be excluded if they expire during their hospitalization or if they have cardiogenic shock (Killip Class 4) at the time of their post-MI coronary angiography due to their poor prognosis.(El-Menyar et al., 2012)
* Patients will also be excluded if they require a translator to receive services in English as recorded in the CCN referral form, as it is infeasible to offer the interventions in multiple languages at this stage.
* Patients whose data are not complete and received in time to deliver the first post-procedure intervention will be excluded as they cannot receive the intervention as intended.
* Patients who do not have an Ontario health card number

Primary outcomes:
measure: Medication adherence
timeFrame: 12 months post-MI
measure: Cardiac rehabilitation completion
timeFrame: 12 months post-MI
Secondary outcomes:
measure: Cardiac rehabilitation attendance
timeFrame: 12 months post-MI
measure: Quality of life
timeFrame: 12 months post-MI
measure: Treatment discussion
timeFrame: 12 months post-MI
measure: Smoking status
timeFrame: 12 months post-MI
measure: Medication persistence
timeFrame: 12 months post-MI
measure: Medication persistence
timeFrame: 12 months post-MI
measure: Medication adherence
timeFrame: 12 months post-MI
measure: Medication adherence
timeFrame: 12 months post-MI
measure: Medication adherence
timeFrame: 12 months post-MI
measure: Medication adherence
timeFrame: 12 months post-MI
measure: Medication adherence
timeFrame: 12 months post-MI
measure: Medication adherence
timeFrame: 12 months post-MI
measure: Medication adherence
timeFrame: 12 months post-MI
measure: Medication adherence
timeFrame: 12 months post-MI
measure: Medication adherence
timeFrame: 12 months post-MI
measure: Cardiovascular event
timeFrame: 12 months post-MI
measure: Mortality
timeFrame: 12 months post-MI
measure: Health utilization
timeFrame: 12 months post-MI
measure: Health utilization
timeFrame: 12 months post-MI
measure: Health utilization
timeFrame: 12 months post-MI
Other outcomes:
Locations:
Study officials:
affiliation: Women's College Hospital
name: Noah Ivers
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: John-David Schwalm
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: Madhu Natarajan
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Jeremy Grimshaw
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Menyar A, Zubaid M, AlMahmeed W, Sulaiman K, AlNabti A, Singh R, Al Suwaidi J. Killip classification in patients with acute coronary syndrome: insight from a multicenter registry. Am J Emerg Med. 2012 Jan;30(1):97-103. doi: 10.1016/j.ajem.2010.10.011. Epub 2010 Dec 14.
citation: McCleary N, Ivers NM, Schwalm JD, Witteman HO, Taljaard M, Desveaux L, Bouck Z, Grace SL, Grimshaw JM, Presseau J. Impacts of two behavior change interventions on determinants of medication adherence: process evaluation applying the health action process approach and habit theory alongside a randomized controlled trial. J Behav Med. 2022 Oct;45(5):659-673. doi: 10.1007/s10865-022-00327-0. Epub 2022 May 20.
citation: Desveaux L, Saragosa M, Russell K, McCleary N, Presseau J, Witteman HO, Schwalm JD, Ivers NM. How and why a multifaceted intervention to improve adherence post-MI worked for some (and could work better for others): an outcome-driven qualitative process evaluation. BMJ Open. 2020 Sep 3;10(9):e036750. doi: 10.1136/bmjopen-2019-036750.
citation: Ivers NM, Schwalm JD, Bouck Z, McCready T, Taljaard M, Grace SL, Cunningham J, Bosiak B, Presseau J, Witteman HO, Suskin N, Wijeysundera HC, Atzema C, Bhatia RS, Natarajan M, Grimshaw JM. Interventions supporting long term adherence and decreasing cardiovascular events after myocardial infarction (ISLAND): pragmatic randomised controlled trial. BMJ. 2020 Jun 10;369:m1731. doi: 10.1136/bmj.m1731.