Myocardial Infarction Prescription Duration Adherence Study (MIPAD)

Length of Initial Prescription at Hospital Discharge and Long-term Medication Adherence for Elderly Patients Post-Myocardial Infarction: An Interventional Study

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Other: 90 Day Supply; Behavioral: Education

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 Type: Interventional
• Enrollment (Actual): 20896
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 90 Day Supply; Policy Change implementing a 90 day standardized discharge prescription form with 3 repeats for all cardiac medications available on all wards where MI patients are managed at Hamilton Health Sciences sites
Experimental: Education Alone; 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.	Behavioral: Education; Education Alone provided at St. Joseph's Hospital and Niagara Health System
No Intervention: Control; Remaining Ontario cardiac sites will receive usual care and act as concurrent control group.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in adherence of medication classes	Difference in proportion with high adherence (mean PDC >80%) to the individual cardiac medication classes	One year
Difference in combined and individual medications as measured by Proportion of Days Covered (PDC)	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).	One year
Discharge Prescription Length	Difference in discharge prescription length (<90 days and ≥90 days)	One year
Clinical outcomes as measured by number of participants who experience death, myocardial infarction, coronary revascularization, and hospital readmission	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.	One year
Cost implications	Cost implications of interventions of each arm	One year

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Institute for Clinical Evaluative Sciences; Population Health Research Institute
• Investigators: Principal Investigator: Jon-David Schwalm, MD,FRCPC,MSc, 905-577-1423

Publications and helpful links

General Publications

• Schwalm JD, Ivers NM, Bouck Z, Taljaard M, Natarajan MK, Nguyen F, Hijazi W, Thavorn K, Dolovich L, McCready T, O'Brien E, Grimshaw JM. Length of initial prescription at hospital discharge and long-term medication adherence for elderly, post-myocardial infarction patients: a population-based interrupted time series study. BMC Med. 2022 Jun 21;20(1):213. doi: 10.1186/s12916-022-02401-5.
• Schwalm JD, Ivers NM, Bouck Z, Taljaard M, Natarajan MK, Dolovich L, Thavorn K, McCready T, O'Brien E, Grimshaw JM. Length of Initial Prescription at Hospital Discharge and Long-Term Medication Adherence for Elderly, Post-Myocardial Infarction Patients: Protocol for an Interrupted Time Series Study. JMIR Res Protoc. 2020 Nov 4;9(11):e18981. doi: 10.2196/18981.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Adherence; Myocardial Infarction; Medication
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 2979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No