NCT03257579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,896

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

September 5, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

June 16, 2017

Last Update Submit

March 14, 2022

Conditions

Medication Adherence

Keywords

Myocardial InfarctionAdherenceMedication

Outcome Measures

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

    One year

Secondary Outcomes (5)

  • Difference in adherence of medication classes

    One year

  • Difference in combined and individual medications as measured by Proportion of Days Covered (PDC)

    One year

  • Discharge Prescription Length

    One year

  • Clinical outcomes as measured by number of participants who experience death, myocardial infarction, coronary revascularization, and hospital readmission

    One year

  • Cost implications

    One year

Study Arms (3)

90 Day Supply

EXPERIMENTAL

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

Education Alone

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

90 Day SupplyOTHER

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

90 Day Supply
EducationBEHAVIORAL

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

Education Alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (2)

  • 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.

    PMID: 35725542DERIVED

  • 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.

    PMID: 33146624DERIVED

MeSH Terms

Conditions

Medication AdherenceMyocardial Infarction

Interventions

Equipment and SuppliesEducational Status

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Jon-David Schwalm, MD,FRCPC,MSc

    905-577-1423

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2017

First Posted

August 22, 2017

Study Start

September 5, 2017

Primary Completion

September 30, 2018

Study Completion

July 31, 2021

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)