Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction

Myocardial Infarction Clinical Trial

— ISLAND  

Official title:

Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382731
• Other study ID #: #06683
• Status: Completed
• Phase: N/A
• First received: March 2, 2015
• Last updated: March 22, 2018
• Start date: September 2015
• Est. completion date: October 2017

Study information

• Verified date: March 2018
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2742
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• Usual care + letters
A series of five postal educational reminders sent on behalf of each hospital's interventional cardiology team to the patient approximately 4, 8, 20, 32, and 44 weeks post-MI procedure, with an insert for the family physician and pharmacist at approximately 4 and 8 weeks post-MI procedure.
• Usual care + letters + automated calls
A series of five postal educational reminders as per the usual care + letters arm 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. The automated algorithm is designed to identify patients who are non-adherent and who may benefit from personalized educational phone call and/or system navigation support by the lay health worker. Lay health workers will not provide clinical advice.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Women's College Hospital	Population Health Research Institute

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	Number of cardiac medication classes with no missed tablets in last week (ordinal) [patient report]	12 months post-MI
Primary	Cardiac rehabilitation completion	Patient attended at least one of the rehabilitation components and formal re-assessment at the conclusion of the program (dichotomous) [patient report]	12 months post-MI
Secondary	Cardiac rehabilitation attendance	Participation, defined as attending at least one exercise session following enrolment assessment (dichotomous) [patient report]	12 months post-MI
Secondary	Quality of life	Seattle Angina Questionnaire-7 [patient report]	12 months post-MI
Secondary	Treatment discussion	Adherence to both medication and exercise discussed with providers in last three months (dichotomous) [patient report]	12 months post-MI
Secondary	Smoking status	Point-prevalence, smoking any cigarettes in last three months (dichotomous) [patient report]	12 months post-MI
Secondary	Medication persistence	Active prescription for ALL recommended medications (dichotomous) [patient report]	12 months post-MI
Secondary	Medication persistence	Active prescription for EACH recommended medication (dichotomous) [patient report]	12 months post-MI
Secondary	Medication adherence	No missed tablets in last week for ANY recommended medication (dichotomous) [patient report]	12 months post-MI
Secondary	Medication adherence	No missed tablets in last month for any recommended medication (dichotomous)[patient report]	12 months post-MI
Secondary	Medication adherence	No missed tablets in last month for ANY recommended medication (dichotomous) [patient report]	12 months post-MI
Secondary	Medication adherence	Number of missed tablets in last week for EACH recommended medication (continuous, 0 to 28) [patient report]	12 months post-MI
Secondary	Medication adherence	Number of missed tablets in last month for each recommended medication (continuous, 0 to 28) [patient report]	12 months post-MI
Secondary	Medication adherence	Medication possession ratio > 80% for ALL recommended medications in those 65+ (dichotomous) [administrative data]	12 months post-MI
Secondary	Medication adherence	Medication possession ratio > 80% for EACH of the recommended medications in those 65+ (dichotomous) [administrative data]	12 months post-MI
Secondary	Medication adherence	Mean medication possession ratio for ALL recommended medications in those 65+ (continuous, 0 to 100) [administrative data]	12 months post-MI
Secondary	Medication adherence	Mean medication possession ratio for EACH recommended medication in those 65+ (continuous, 0 to 100) [administrative data]	12 months post-MI
Secondary	Cardiovascular event	Coronary bypass surgery or stent or repeat MI (dichotomous) [administrative data]	12 months post-MI
Secondary	Mortality	Death during follow-up [administrative data]	12 months post-MI
Secondary	Health utilization	Outpatient visits (count) [administrative data]	12 months post-MI
Secondary	Health utilization	Emergency Room visits not leading to admission (count) [administrative data]	12 months post-MI
Secondary	Health utilization	Hospitalizations (count) [administrative data]	12 months post-MI