Myocardial Infarction Prescription Duration Adherence Study

Not Applicable

Completed

• Conditions: Medication Adherence
• Interventions: Behavioral: Education; Other: 90 Day Supply

• Registration Number: NCT03257579
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

Quasi-experimental, controlled interrupted time series design, evaluating the impact of the intervention at Hamilton Health Sciences (HHS) where standardized prescriptions and education will be provided and St Joseph's Hospital (SJH) and Niagara Health Services (NHS) where education alone will be provided, with remaining Ontario cardiac sites as a concurrent control group.

Detailed Description

The overarching goal of this study is to reduce the morbidity and mortality of post-MI patients through improved long-term cardiac medication adherence.

The specific objectives include: 1. Assess the impact on long-term cardiac medication adherence following the implementation of a standardized increase in discharge prescription length to 90-days with 3 repeats in post-MI patients as compared to education alone and usual care; 2. Assess the cost implications of the intervention as compared to usual care; 3. Compare clinical outcomes between longer (\>60 days) versus shorter prescription durations; 4. Collect baseline information to inform a multi-centre interventional study (i.e., simple monthly proportions of 1-year adherence by hospitals in Ontario).

Intervention:1. Policy Change implementing a standardized discharge prescription form available on all wards where MI patients are managed at HHS that includes a 90-day supply with 3 repeats for all cardiac medications, and education alone provided at SJH and NHS 2. Educational materials will be disseminated to all involved health care providers (e.g., physicians, residents, nurses) at the start of the intervention period to ensure the new discharge prescriptions are understood and used. Furthermore, extensive outreach to community pharmacies in LHIN IV will be undertaken with help from Ontario Pharmacists' Association (OPA) and Ontario Pharmacy Evidence Network (OPEN).

3. Education (e.g., emails, mail-outs, site visits) will recur every 3-4 months during the intervention period. Furthermore, monthly monitoring will ensure standardized prescription forms and point of care reminders are implemented at all intervention sites.

The intervention group will be exposed to this intervention post-MI and include all eligible patients at HHS/SJH/NHS in the 6-months post-intervention implementation.

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-22
• Study Start: 2017-09-05
• Primary Completion: 2018-09-30
• Study Completion: 2021-07-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20896

Inclusion Criteria

• Use of Ontario Drug Benefits (ODB-Age >65 years, social assistance, and disability);
• Cardiac catheterization during an index admission with an MI;
• Evidence of obstructive coronary artery disease;
• Discharged alive
• Ontario Residents (Ontario, Canada)

Read More

Exclusion Criteria

• None

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Education Alone	Education	At St. Joseph's Hospital and Niagara Health System education regarding the benefits of lengthening prescriptions to a 90 day supply with 3 repeats for all cardiac medications will be implemented.
90 Day Supply	90 Day Supply	Intervention: At Hamilton Health Sciences a policy change implementing a standardized discharge prescription form of a 90-day supply with 3 repeats for all cardiac medications available on all wards where MI patients are managed.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients with High Adherence	One year	Increased proportion of patients with high adherence (proportion of days covered (PDC) \>80%) for the combined four cardiac medications classes at one year

Secondary Outcome Measures

Name	Time	Method
Discharge Prescription Length	One year	Difference in discharge prescription length (\<90 days and ≥90 days)
Difference in combined and individual medications as measured by Proportion of Days Covered (PDC)	One year	Difference in mean of Proportion of Days Covered (PDC \>80%) of the combined cardiac medications as compared to PDC of individual cardiac medications classes as collected by Ontario Drug Benefits usage and reported to the Institute of Clinical Evaluative Sciences (ICES).
Cost implications	One year	Cost implications of interventions of each arm
Difference in adherence of medication classes	One year	Difference in proportion with high adherence (mean PDC \>80%) to the individual cardiac medication classes
Clinical outcomes as measured by number of participants who experience death, myocardial infarction, coronary revascularization, and hospital readmission	One year	Difference in proportion of participants experiencing death, myocardial infarction, coronary revascularization and hospital readmission at one year at each interventional site compared to control sites, as reported by Cardiac Care Network and analyzed by ICES.

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada