Improving Goal Directed Medical Therapy for Device Clinic Patients With Reduced Ejection Fraction at the University of Ottawa Heart Institute: a Quality Improvement Initiative (VIGILANT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 2,500
- Locations
- 2
- Primary Endpoint
- Goal directed medical therapy compliance
Study Overview
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.
Detailed Description
The goal of this quality improvement initiative is to optimize goal directed medical therapy compliance (GDMT) in heart failure (HF) patients seen at the University of Ottawa Heart Institute (UOHI) device clinic. GDMT is reported as low as 45% and a recent Canadian survey reports estimated compliance as low as 15%. The project will be performed in 3 phases. Phase 1 will aim to establish the rates of GDMT compliance in heart failure patients seen through the device clinic. The chart of 600 consecutive implantable cardioverter defibrillator (ICD) patients will be reviewed to establish the current compliance rate with GDMT in patients with reduced ejection fraction (EF). In Phase 2, the goal is to optimize GDMT through collaboration between the HF clinic and 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 ultimate goal is to improve the quality of life of patients seen at the institute. In Phase 3, the compliance rate will be re-evaluated every 6 months to assess for improvement in GDMT in this patient population.
During Phase 1 (establishing baseline medication compliance), the charts of 600 consecutive ICD patients will be reviewed using PACeART and EPIC databases. Rate of GDMT compliance will be calculated. For the purposes of this investigation, and in patients with EF < 40% at the time of ICD clinic visit, GDMT is defined as:
- NHYA I and ACE-I/ARB OR ARNI+BB+MRA+SGL2 or
- NYHA II or above and on ARNI+BB+MRA+SGL2
ACE-I refers to Angiotensin-converting-enzyme inhibitor medication, ARB refers to Angiotensin II receptor blocker medication, ARNI refers to angiotensin receptor neprilysin inhibitor medication, BB refers to beta blocker medication, MRA refers to aldosterone receptor antagonist medication, and SGL2 refers to sodium-glucose cotransporter-2 inhibitor medication.
During Phase 2 (medication optimization through collaborative work with heart function clinic, primary cardiologist and device clinic), all patients seen with ICD and reduced EF at the UOHI device clinic will be given a questionnaire by the clinic assistant. The questionnaire will be comprised of 2 questions:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with implantable cardioverter-defibrillator
- •Ejection fraction ≤ 35%
Exclusion Criteria
- •None (QA project)
Outcomes
Primary Outcomes
Goal directed medical therapy compliance
Time Frame: 6 months
Rate of compliance will be assessed in this initiative
Secondary Outcomes
No secondary outcomes reported
Investigators
Mehrdad Golian
Cardiologist
Ottawa Heart Institute Research Corporation