Implementation of an Encounter-based Patient Decision Aid for Heart Failure Medications in Heart Function Clinics: the SHARE-HF Pragmatic, Stepped-wedge Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,350
- 主要终点
- Efficacy-weighted HFrEF guideline-directed medical therapy (GDMT) score
研究概览
简要总结
The goal of this clinical trial is to learn if a shared decision-making tool called SHARE-HF can help more people with heart failure receive guideline-recommended medications. The study includes adults with a type of heart failure called heart failure with reduced ejection fraction (HFrEF), who attend heart function clinics in British Columbia, Canada. The main question it aims to answer is:
- Does use of SHARE-HF during clinic visits lead to more participants receiving their recommended heart failure medications after 6 months?
Researchers will compare clinics using the SHARE-HF tool to clinics providing usual care to see if the tool helps more participants get their recommended medications.
Participants will use the SHARE-HF web-based tool with their clinician during regular clinic visits. The tool shows participants how their heart failure may affect their health over time, explains their medication options, and helps them and their clinician make treatment decisions together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient in a participating HF clinic;
- •In-person initial HF clinic visit;
- •Age 40-85 years;
- •Heart failure with reduced ejection fraction (HFrEF), as indicated by latest cardiac imaging demonstrating ejection fraction ≤40%.
排除标准
- •Previous request to the clinic not to be contacted for research;
- •Consent opt-out;
- •Non-BC residents;
- •Residents of long-term care facilities or hospice;
- •Receiving palliative care;
- •End-stage kidney disease on dialysis or latest estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2.
结局指标
主要结局
Efficacy-weighted HFrEF guideline-directed medical therapy (GDMT) score
时间窗: 6 months
Scores range from 0 to 8, with a higher score indicating greater (better) GDMT utilization.
次要结局
- Worsening heart failure events(1 year; 3 years)
- Adherence to HFrEF GDMT(1 year; 3 years)
- Average percent concordance between prescribed and dispensed prescriptions for GDMT(1 year)
- Utilization of individual HFrEF medication classes at any dose(Months 3, 6, and 12)
研究者
Ricky Turgeon
Associate Professor
University of British Columbia