Primary Palliative Care in Heart Failure: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of enrolling 30 patients via attempting to enroll 30 patients
研究概览
简要总结
Patients with advanced heart failure (HF) typically experience significant burdens that negatively impact their quality of life. Although palliative care has been shown to improve patient outcomes in other serious illnesses, insufficient data exist to support its use in HF. Furthermore, the demand for palliative care in serious illness outstrips the available supply of certified palliative care clinicians. This pilot trial will assess the feasibility and acceptability of training cardiology nurses in basic palliative care skills and their ability to deliver this care alongside usual HF management.
详细描述
Patients with advanced heart failure (HF) suffer from significant pain, fatigue, difficulty breathing, anxiety, and depression. Palliative Care (PC) is a medical specialty designed to focus on relieving patient suffering by providing an extra layer of support on top of usual care. To date, there has been little research on the impact of PC in HF. We will conduct a randomized clinical trial to assess the feasibility, acceptability, and perceived effectiveness of training cardiology nurses in PC and administering PC to their patients. Patients will be randomized into either the usual care group or the intervention group. Usual care participants will receive their care with no alterations, and intervention participants will receive the PC intervention from their nurse on top of their usual care. Both groups will complete health-related surveys on tablet computers, via email, and/or via telephone. In the intervention group, these answers will be used to tailor the intervention to the specific patient's needs. Caregivers will also be recruited into the study, and will complete surveys similar to the patients via the aforementioned methods.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New York Heart Association Class III or IV Heart Failure
- •2 or more hospitalizations in the past year due to Heart Failure
排除标准
- •Less than 40 years old
- •Currently awaiting a transplant
- •Received outpatient palliative care within the past 12 months
- •Pregnant or intends to be within the next 12 months
- •No regular phone access
- •Not fluent in English
- •Failed the Callahan 6-item Screener
- •Does not intent to regularly attend clinic for the next 12 months
结局指标
主要结局
Feasibility of enrolling 30 patients via attempting to enroll 30 patients
时间窗: One year
We will assess the feasibility of enrolling 30 patients by attempting to enroll 30 patients.
次要结局
- Intervention Acceptability(Two years)
- Intervention Fidelity via the Intervention Fidelity Monitoring Report(Two years)
研究者
Robert Arnold
Professor
University of Pittsburgh