Improving Goal Directed Medical Therapy for Device Clinic Patients With Reduced EF at UOHI: a QI Initiative (VIGILANT)

NCT05085249 | Completed

• 1 other identifier: 2021_Vigilant_QA
• Study Type: observational
• Target: 2,479
• Locations: 1 country
• Sites: 1

Brief Summary

This is a quality improvement initiative with the goal of optimizing heart failure (HF) patients seen through the outpatient cardiac implantable electronic device clinic at the University of Ottawa Heart Institute (UOHI). The UOHI device clinic oversees more than 12,000 in-clinic patient visits annually with over 5000 visits for patients with reduced ejection fraction (EF) and HF. In patients with reduced EF, guideline directed medical therapy compliance (GDMT) is sub-optimal in real world clinical practice. Considering the most recent changes to The Canadian Cardiovascular Society heart failure guideline recommendations, the compliance rate may be even lower than reported rates in the literature. The goal of this study is to optimize GDMT through collaboration between the HF clinic, a HF/arrhythmia nurse practitioner, and application of a nurse run algorithm based pathway to identify patients suitable for medication optimization and guiding the most responsible physician (MRP) for their heart failure (PCP, cardiologist or HF physician) through a letter. The compliance rate will also be re-evaluated to assess improvement in GDMT in this patient population. GDMT will ensure the greatest chance to improve patient outcomes by reducing heart failure hospitalizations, emergency room visits, ventricular arrhythmias, implantable cardioverter defibrillator shocks, clinic visits, and thereby improving patients' quality of life.

Conditions

Heart Failure

Keywords

Quality assurance; Medication optimization; Device clinic; Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Goal directed medical therapy compliance

  Rate of compliance will be assessed in this initiative

  6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen at the University of Ottawa Heart Institute electronic device clinic who have an implantable cardioverter defibrillator device. Patients served are primarily from Ottawa and the surrounding region. As a tertiary care centre, UOHI also sees referrals from other regions across Canada.

You may qualify if:

• Patients with implantable cardioverter-defibrillator
• Ejection fraction ≤ 35%

You may not qualify if:

• None (QA project)

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Novartis: collaborator
• Servier: collaborator
• AstraZeneca: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mehrdad Golian, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 20, 2021
• Study Start: July 14, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)