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Completed

NCT Number: NCT03257579

Myocardial Infarction Prescription Duration Adherence 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.

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Key information

About this study

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).

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

90 Day Supply

Other

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

Education

Behavioral

Education Alone provided at St. Joseph's Hospital and Niagara Health System

Primary outcomes

  1. Proportion of Patients with High Adherence

    Time frame: 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 outcomes

  1. Difference in adherence of medication classes

    Time frame: One year

    Difference in proportion with high adherence (mean PDC >80%) to the individual cardiac medication classes

  2. Difference in combined and individual medications as measured by Proportion of Days Covered (PDC)

    Time frame: 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).

  3. Discharge Prescription Length

    Time frame: One year

    Difference in discharge prescription length (<90 days and ≥90 days)

  4. Clinical outcomes as measured by number of participants who experience death, myocardial infarction, coronary revascularization, and hospital readmission

    Time frame: 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.

  5. Cost implications

    Time frame: One year

    Cost implications of interventions of each arm

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Institute for Clinical Evaluative Sciences
  • Population Health Research Institute

Registry information

Official study title

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

Acronym: MIPAD

Important dates

Study start
2017
Primary completion
2018
Study completion
2021
First posted
Aug 22, 2017
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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