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临床试验/NCT05085249
NCT05085249招募中不适用

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)

Ottawa Heart Institute Research Corporation2 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2021年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,500
试验地点
2
主要终点
Goal directed medical therapy compliance

研究概览

简要总结

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.

详细描述

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:

  1. NHYA I and ACE-I/ARB OR ARNI+BB+MRA+SGL2 or
  2. 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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • None (QA project)

结局指标

主要结局

Goal directed medical therapy compliance

时间窗: 6 months

Rate of compliance will be assessed in this initiative

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehrdad Golian

Cardiologist

Ottawa Heart Institute Research Corporation

研究点 (2)

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