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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03257579
Other study ID # 2979
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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