Implementing Collaborative Care to Alleviate Symptoms and Adjust to Heart Failure: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Cohort Retention
研究概览
简要总结
The overall goal of this study is to evaluate the pilot implementation of two palliative care interventions in veterans with chronic heart failure at the Denver VA Medical Center. This is a study of behavioral and care strategy interventions and involves no investigational drugs or devices.
详细描述
The investigators will examine the feasibility of two palliative care interventions designed to improve different facets of quality of life. Briefly, the two interventions are:
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A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes
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evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse;
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a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and
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brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
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A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
The specific aims of the study are to:
- Examine intervention feasibility and determine preliminary estimates of intervention effect
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eligible veterans from the Denver VAMC will have a prior primary discharge diagnosis of heart failure in the last year,
- •be at least 18 years of age, able to read and understand English,
- •have consistent access to a telephone
- •at least one of the following:
- •Kansas City Cardiomyopathy Questionnaire (KCCQ) score less than or equal to 60;
- •a second hospitalization for with a primary discharge diagnosis of heart failure in the last year;
- •taking at least 80 mg oral furosemide (or equivalent) daily in a single or divided dose for at least 2 weeks;
- •BNP greater than or equal to 250 or NT-proBNP greater than or equal to 1000; or
- •estimated creatinine clearance 30-80 mL/min.
排除标准
- •previous diagnosis of dementia;
- •active substance abuse, defined as an AUDIT-C score greater than 7, two positive responses on substance abuse screening questions, or medical records indicating active substance abuse or dependence;
- •comorbid metastatic cancer, given the focus on heart failure palliative care;
- •nursing home resident; and
- •diagnosis of bipolar disorder or schizophrenia.
研究组 & 干预措施
Collaborative Care to Alleviate Symptoms and Adjust to Illness
A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
干预措施: Collaborative Care to Alleviate Symptoms and Adjust to Illness (Other)
Psychospiritual
A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
干预措施: Psychospiritual (Behavioral)
结局指标
主要结局
Cohort Retention
时间窗: 3 months
Cohort retention will be determined by examining the proportion of patients who complete the final study visit (at 3-month follow-up) over the total number of patients enrolled in the study (including deceased and lost-to-follow-up). Our goal is an 80% retention rate for this pilot study.
次要结局
- Was Depression Addressed?(3 months)
- Participation Rates(7 months)
- Adherence to the Study Protocol (CASA Arm Only)(3 months)