MIPAD: Myocardial Infarction Prescription Duration Adherence Study

Sponsor
Hamilton Health Sciences Corporation (Other)
Overall Status
Completed
CT.gov ID
NCT03257579
Collaborator
Population Health Research Institute (Other), Institute for Clinical Evaluative Sciences (Other)
20,896
1
3
46.8
446.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 90 Day Supply
  • Behavioral: Education
N/A

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).

  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
20896 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Length of Initial Prescription at Hospital Discharge and Long-term Medication Adherence for Elderly Patients Post-Myocardial Infarction: An Interventional Study
Actual Study Start Date :
Sep 5, 2017
Actual Primary Completion Date :
Sep 30, 2018
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Difference in adherence of medication classes [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) [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 [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 [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 [One year]

    Cost implications of interventions of each arm

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hamilton General Hospital Hamilton Ontario Canada L8L 2X2

Sponsors and Collaborators

  • Hamilton Health Sciences Corporation
  • Population Health Research Institute
  • Institute for Clinical Evaluative Sciences

Investigators

  • Principal Investigator: Jon-David Schwalm, MD,FRCPC,MSc, 905-577-1423

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT03257579
Other Study ID Numbers:
  • 2979
First Posted:
Aug 22, 2017
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hamilton Health Sciences Corporation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022