Focused Palliative Care Intervention in Advanced Heart Failure
Pilot Study of a Focused Palliative Care Intervention for Recently Hospitalized High-Risk Patients With Heart Failure
研究概览
详细说明
Patients will be assigned to one of two groups a) longitudinal goals of care discussion led by a palliative care-trained social worker or b) usual care + written information regarding advanced directives. The intervention group will be enrolled in the hospital and then be followed longitudinally for 3 months by a palliative care-trained social worker who will shepherd a conversation around prognosis, expectations, and goals of care. The results of these conversations will be documented in the electronic medical record and shared with the clinical team. Clinical symptoms that are identified during these conversations will be evaluated by a Palliative Care Physician who will relay suggestions regarding management to the primary treating clinician. Baseline surveys will assess prognostic awareness, symptom burden, anxiety, depression, and quality of life for both groups. At the conclusion of the study, an individualized follow-up plan will be devised for each patient based on a needs assessment by the study social worker.
Patients assigned to the control/usual care arm will complete the same series of questionnaires as those assigned to the intervention group and will undergo usual in hospital and post-discharge treatment as directed by their care team. All control subjects will receive written Advanced Care planning and Heart Failure education materials as provided routinely to inpatients at Brigham and Women's Hospital. At the 6 month visit following hospitalization, these patients will be asked to complete follow up questionnaires and then will be given the option to participate in the above verbal intervention and guided "Goals and Values" conversation that was provided to the intervention group.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Symptomatic Heart Failure (NYHA II-IV)
Hospitalized or recently for acute decompensation with at least one of the following high-risk features
- Prior hospitalization for Heart Failure (HF) within 1 year
- Age > 80 years
- Chronic Kidney Disease (estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/m2)
- Systolic Blood Pressure < 100 mm Hg
- Serum sodium < 130 meq/L
- Cardiogenic Shock (Cardiac Index < 2.0)
- Serious Non-Cardiovascular Illness (e.g. advanced stage cancer, Chronic Obstructive Pulmonary Disease (COPD) , or the like.
- Ability to Provide Informed Consent
- Permission of attending physician
Exclusion Criteria
- Anticipated major cardiac surgery, including Ventricular Assist Device (VAD) or transplant, within 3 months of enrollment
- Already enrolled in hospice or receiving outpatient palliative care
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Control
Participant will receive usual care for Heart Failure patients, which include standard written material on Advanced Care planning and supportive cardiology/palliative care consult if ordered by attending.
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The control group will receive usual written care material and a palliative care consult if ordered by physician.
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实验性的:Verbal Information and Discussion
Participants will participate in a guided goals of care conversation and the support of a Palliative Care Social Worker who is working closely with the patients' primary cardiology team.
Social worker has ongoing clinical review of participants with a Palliative Care physician who will provide a full medical consult if appropriate.
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Intervention patient will receive a outpatient session with a palliative care social worker in the heart failure clinic two weeks post discharge consent focusing on goals of care.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?
大体时间:6 months
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Assessment tool: Patient Preferences Questionnaire.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?
大体时间:6 months
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Chart review of Advanced Care Planning documents and written notes by members of clinical team.
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6 months
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Is there an impact on symptom burden through a palliative care intervention?
大体时间:Three months
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Assessment tool: : The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
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Three months
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Is there an impact on perceived level of illness through a palliative care intervention?
大体时间:6 months
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Assessment tool: EQ visual analogue scale (EQ-VAS)
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6 months
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Is there an impact on overall patient well being through a palliative care intervention?
大体时间:Three months
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Assessment tool: The Functional Assessment of Chronic Illness Therapy ( FACIT-Sp)
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Three months
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Is there an impact on depression through a palliative care intervention?
大体时间:6 months
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Assessment tool: Patient Health Questionnaire (PHQ-8)
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6 months
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Is there an impact on anxiety through a palliative care intervention?
大体时间:6 months
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Assessment tool: General Anxiety Disorder (GAD-7)
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6 months
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Is there an impact on cost of treatment through a palliative care intervention?
大体时间:6 months
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Focus will be on cost through health care utilization as aggregated by number of hospital days, days in ICU and 30 day re-admissions.
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6 months
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合作者和调查者
调查人员
- 首席研究员:Akshay S Desai, MPH, MD、Brigham and Women's Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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