Clinical trial NCT02805712: Focused Palliative Care Intervention in Advanced Heart Failure
Official title: Pilot Study of a Focused Palliative Care Intervention for Recently Hospitalized High-Risk Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Quality of Life
Keywords: Heart Failure
Palliative Care
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?
timeFrame: 6 months
Secondary outcomes:
measure: Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?
timeFrame: 6 months
measure: Is there an impact on symptom burden through a palliative care intervention?
timeFrame: Three months
measure: Is there an impact on perceived level of illness through a palliative care intervention?
timeFrame: 6 months
measure: Is there an impact on overall patient well being through a palliative care intervention?
timeFrame: Three months
measure: Is there an impact on depression through a palliative care intervention?
timeFrame: 6 months
measure: Is there an impact on anxiety through a palliative care intervention?
timeFrame: 6 months
measure: Is there an impact on cost of treatment through a palliative care intervention?
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Akshay S Desai, MPH, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Donnell AE, Schaefer KG, Stevenson LW, DeVoe K, Walsh K, Mehra MR, Desai AS. Social Worker-Aided Palliative Care Intervention in High-risk Patients With Heart Failure (SWAP-HF): A Pilot Randomized Clinical Trial. JAMA Cardiol. 2018 Jun 1;3(6):516-519. doi: 10.1001/jamacardio.2018.0589.