Clinical trial NCT03257579: Myocardial Infarction Prescription Duration Adherence Study
Official title: Length of Initial Prescription at Hospital Discharge and Long-term Medication Adherence for Elderly Patients Post-Myocardial Infarction: An Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: Myocardial Infarction
Adherence
Medication
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Population Health Research Institute
name: Institute for Clinical Evaluative Sciences
First posted: 2017-08-22
Enrollment: 20896
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients with High Adherence
timeFrame: One year
Secondary outcomes:
measure: Difference in adherence of medication classes
timeFrame: One year
measure: Difference in combined and individual medications as measured by Proportion of Days Covered (PDC)
timeFrame: One year
measure: Discharge Prescription Length
timeFrame: One year
measure: Clinical outcomes as measured by number of participants who experience death, myocardial infarction, coronary revascularization, and hospital readmission
timeFrame: One year
measure: Cost implications
timeFrame: One year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: 905-577-1423
name: Jon-David Schwalm, MD,FRCPC,MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwalm JD, Ivers NM, Bouck Z, Taljaard M, Natarajan MK, Nguyen F, Hijazi W, Thavorn K, Dolovich L, McCready T, O'Brien E, Grimshaw JM. Length of initial prescription at hospital discharge and long-term medication adherence for elderly, post-myocardial infarction patients: a population-based interrupted time series study. BMC Med. 2022 Jun 21;20(1):213. doi: 10.1186/s12916-022-02401-5.
citation: Schwalm JD, Ivers NM, Bouck Z, Taljaard M, Natarajan MK, Dolovich L, Thavorn K, McCready T, O'Brien E, Grimshaw JM. Length of Initial Prescription at Hospital Discharge and Long-Term Medication Adherence for Elderly, Post-Myocardial Infarction Patients: Protocol for an Interrupted Time Series Study. JMIR Res Protoc. 2020 Nov 4;9(11):e18981. doi: 10.2196/18981.