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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02805712
Enrollment
50
Registered
2016-06-20
Start date
2014-09-30
Completion date
2016-12-01
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Quality of Life

Keywords

Heart Failure, Palliative 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.

Interventions

OTHERControl

The control group will receive usual written care material and a palliative care consult if ordered by physician.

OTHERVerbal Information and Discussion

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.

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?6 monthsAssessment tool: Patient Preferences Questionnaire.

Secondary

MeasureTime frameDescription
Is there an impact on symptom burden through a palliative care intervention?Three monthsAssessment tool: : The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Is there an impact on perceived level of illness through a palliative care intervention?6 monthsAssessment tool: EQ visual analogue scale (EQ-VAS)
Is there an impact on overall patient well being through a palliative care intervention?Three monthsAssessment tool: The Functional Assessment of Chronic Illness Therapy ( FACIT-Sp)
Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?6 monthsChart 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 monthsAssessment tool: General Anxiety Disorder (GAD-7)
Is there an impact on cost of treatment through a palliative care intervention?6 monthsFocus 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 depression through a palliative care intervention?6 monthsAssessment tool: Patient Health Questionnaire (PHQ-8)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026