University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
NCT Number: NCT05085249
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.
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Observational
Ottawa, Ontario, K1Y 4W7, Canada
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:
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:
If patient has answered no to both questions of the survey they will be classified as NYHA I, all others will be classified as NYHA II or greater. Medication lists will be updated for all patients by the device clinic nurse in EPIC. Blood pressure and pulse will also be documented in EPIC by the device clinic nurse for all in-person appointments. A clinical nurse or physician assistant will review all patient visits for ICD and reduced EF at the UOHI device clinic, patients not on GDMT (defined above) will have a letter sent to their cardiologist with recommendations on medication change and required follow up. Those without a cardiologist will be referred to the heart function clinic at UOHI or general hospital for medication optimization. Patients will be categorized into 4 groups:
Those on GDMT will continue on the same medication with no change. In patients with EF < 40% at the time of ICD clinic visit, GDMT is defined as:
During Phase 3 (re-evaluation), patients will bring the letter from their cardiologist stating the reason why they were not started on the recommended medication (i.e. renal function, patient preference, urinary tract infection, low blood pressure, hyperkalemia etc.). The medication use will be rated every 6 months through EPIC to assess for increase in medication uptake. In addition, annually 35 (approximately 10% of the ICD implants) randomly selected ICD patients with reduced ejection fraction from the device clinic will be assessed regarding GDMT.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months
Rate of compliance will be assessed in this initiative
Ottawa Heart Institute Research Corporation
Other
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)
Acronym: VIGILANT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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