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Myocardial Infarction Prescription Duration Adherence Study (MIPAD)

Primary Purpose

Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
90 Day Supply
Education
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Medication Adherence focused on measuring Myocardial Infarction, Adherence, Medication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

90 Day Supply

Education Alone

Control

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference in adherence of medication classes
Difference in proportion with high adherence (mean PDC >80%) to the individual cardiac medication classes
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).
Discharge Prescription Length
Difference in discharge prescription length (<90 days and ≥90 days)
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.
Cost implications
Cost implications of interventions of each arm

Full Information

First Posted
June 16, 2017
Last Updated
March 14, 2022
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Population Health Research Institute, Institute for Clinical Evaluative Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03257579
Brief Title
Myocardial Infarction Prescription Duration Adherence Study
Acronym
MIPAD
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Population Health Research Institute, Institute for Clinical Evaluative Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence
Keywords
Myocardial Infarction, Adherence, Medication

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20896 (Actual)

8. Arms, Groups, and Interventions

Arm Title
90 Day Supply
Arm Type
Experimental
Arm Description
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.
Arm Title
Education Alone
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Remaining Ontario cardiac sites will receive usual care and act as concurrent control group.
Intervention Type
Other
Intervention Name(s)
90 Day Supply
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Education Alone provided at St. Joseph's Hospital and Niagara Health System
Primary Outcome Measure Information:
Title
Proportion of Patients with High Adherence
Description
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 Outcome Measure Information:
Title
Difference in adherence of medication classes
Description
Difference in proportion with high adherence (mean PDC >80%) to the individual cardiac medication classes
Time Frame
One year
Title
Difference in combined and individual medications as measured by Proportion of Days Covered (PDC)
Description
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
Title
Discharge Prescription Length
Description
Difference in discharge prescription length (<90 days and ≥90 days)
Time Frame
One year
Title
Clinical outcomes as measured by number of participants who experience death, myocardial infarction, coronary revascularization, and hospital readmission
Description
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
Title
Cost implications
Description
Cost implications of interventions of each arm
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon-David Schwalm, MD,FRCPC,MSc
Organizational Affiliation
905-577-1423
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35725542
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.
Results Reference
derived
PubMed Identifier
33146624
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.
Results Reference
derived

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Myocardial Infarction Prescription Duration Adherence Study

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