An interventional study of 90 Day Supply and Education in Medication Adherence, sponsored by Hamilton Health Sciences Corporation. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Health services research
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.
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).
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.
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's enrollment of 20,896 is above the median of 120 across 768 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
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
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
Remaining Ontario cardiac sites will receive usual care and act as concurrent control group.
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 Alone provided at St. Joseph's Hospital and Niagara Health System
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
Time frame: One year
Difference in adherence of medication classes
Difference in proportion with high adherence (mean PDC \>80%) to the individual cardiac medication classes
Time frame: 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).
Time frame: One year
Discharge Prescription Length
Difference in discharge prescription length (\<90 days and ≥90 days)
Time frame: 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.
Time frame: One year
Cost implications
Cost implications of interventions of each arm
Time frame: One year
Plan to share: No
Ran from Sep 2017 to primary completion in Sep 2018, 12 months.
Of 425 non-industry interventional studies with no phase under Medication Adherence, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's 12 months is below that.
Counting every sponsor, half of 442 studies reached it within 21 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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