Myocardial Infarction Prescription Duration Adherence Study

NCT ID: NCT03257579

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20896 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-05
• Study Completion Date: 2021-07-31

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.

Conditions

Medication Adherence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

90 Day Supply

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Education

Intervention Type: BEHAVIORAL

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

90 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

Intervention Type: OTHER

Education

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: collaborator

Institute for Clinical Evaluative Sciences

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon-David Schwalm, MD,FRCPC,MSc

Role: PRINCIPAL_INVESTIGATOR

905-577-1423

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35725542 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33146624 (View on PubMed)

Other Identifiers

2979

Identifier Type: -

Identifier Source: org_study_id