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Clinical Trials/NCT02805712
NCT02805712
Completed
N/A

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

Brigham and Women's Hospital1 site in 1 country50 target enrollmentSeptember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Brigham and Women's Hospital
Enrollment
50
Locations
1
Primary Endpoint
Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 1, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Akshay Desai, MD

Director, Heart Failure Disease Management Program

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 6 months

Assessment tool: Patient Preferences Questionnaire.

Secondary Outcomes

  • 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)

Study Sites (1)

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