Myocardial Infarction Prescription Duration Adherence Study

Medication Adherence Clinical Trial

— MIPAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257579
• Other study ID #: 2979
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2022
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20896
• Est. completion date: July 31, 2021
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Medication Adherence
• Myocardial Infarction

Intervention

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

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

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Institute for Clinical Evaluative Sciences, Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in adherence of medication classes	Difference in proportion with high adherence (mean PDC >80%) to the individual cardiac medication classes	One year
Secondary	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
Secondary	Discharge Prescription Length	Difference in discharge prescription length (<90 days and =90 days)	One year
Secondary	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
Secondary	Cost implications	Cost implications of interventions of each arm	One year