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CompletedNCT03257579MIPADUpdated Mar 16, 2022

Myocardial Infarction Prescription Duration Adherence Study

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

Phase
Not applicable
Study type
Interventional
Enrollment
20,896
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Medication Adherence

Keywords

  • Myocardial Infarction
  • Adherence
  • Medication
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • None
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
20,896 participants (actual)

Study arms

  • 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

  • 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

  • No intervention
    Control

    Remaining Ontario cardiac sites will receive usual care and act as concurrent control group.

Interventions

  • Other90 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

  • BehavioralEducation

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

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Discharge Prescription Length

    Difference in discharge prescription length (\<90 days and ≥90 days)

    Time frame: One year

  4. 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

  5. Cost implications

    Cost implications of interventions of each arm

    Time frame: One year

06

Study locations

1 site
  • Hamilton General Hospital
    Hamilton, Ontario L8L 2X2, Canada
07

References and documents

Publications

  • 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. PubMed 35725542 ↗
  • 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. PubMed 33146624 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03257579
Lead sponsor
Hamilton Health Sciences Corporation
Collaborators
Population Health Research Institute, Institute for Clinical Evaluative Sciences
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Sep 5, 2017
Primary completion
Sep 30, 2018
Completion
Jul 31, 2021
Last update
Mar 16, 2022

Study contacts

Jon-David Schwalm, MD,FRCPC,MSc
principal investigator · 905-577-1423

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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