跳至主要内容
临床试验/NCT02805712
NCT02805712已完成不适用

Pilot Study of a Focused Palliative Care Intervention for Recently Hospitalized High-Risk Patients With Heart Failure

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?

研究概览

简要总结

This small pilot study will be assessing the the impact of a standardized, social-worker led, longitudinal palliative care intervention on alignment of patient and physician understanding of prognosis and goals of care. Secondary objectives include assessing the impact of this intervention on documentation of advanced care planning and end of life preferences, symptom burden, quality of life and health care utilization.

详细描述

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Control

Active Comparator

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.

干预措施: Control (Other)

Verbal Information and Discussion

Experimental

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.

干预措施: Verbal Information and Discussion (Other)

结局指标

主要结局

Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?

时间窗: 6 months

Assessment tool: Patient Preferences Questionnaire.

次要结局

  • Is there an impact on cost of treatment through a palliative care intervention?(6 months)
  • Is there an impact on symptom burden through a palliative care intervention?(Three months)
  • Is there an impact on depression through a palliative care intervention?(6 months)
  • Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?(6 months)
  • Is there an impact on anxiety through a palliative care intervention?(6 months)
  • Is there an impact on perceived level of illness through a palliative care intervention?(6 months)
  • Is there an impact on overall patient well being through a palliative care intervention?(Three months)

研究者

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

Akshay Desai, MD

Director, Heart Failure Disease Management Program

Brigham and Women's Hospital

研究点 (2)

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