Focused Palliative Care Intervention in Advanced Heart Failure

Not Applicable

Completed

• Conditions: Quality of Life; Heart Failure

• Registration Number: NCT02805712
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-05-20
• Primary Completion: 2016-06
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-20
• Study Completion: 2016-12-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?	6 months	Assessment tool: Patient Preferences Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Is there an impact on cost of treatment through a palliative care intervention?	6 months	Focus will be on cost through health care utilization as aggregated by number of hospital days, days in ICU and 30 day re-admissions.
Is there an impact on symptom burden through a palliative care intervention?	Three months	Assessment tool: : The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Is there an impact on depression through a palliative care intervention?	6 months	Assessment tool: Patient Health Questionnaire (PHQ-8)
Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?	6 months	Chart review of Advanced Care Planning documents and written notes by members of clinical team.
Is there an impact on anxiety through a palliative care intervention?	6 months	Assessment tool: General Anxiety Disorder (GAD-7)
Is there an impact on perceived level of illness through a palliative care intervention?	6 months	Assessment tool: EQ visual analogue scale (EQ-VAS)
Is there an impact on overall patient well being through a palliative care intervention?	Three months	Assessment tool: The Functional Assessment of Chronic Illness Therapy ( FACIT-Sp)

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States