Overview

This trial is active, not recruiting.

Conditions heart failure, quality of life
Treatments verbal information and discussion, control
Sponsor Brigham and Women's Hospital
Start date September 2014
End date June 2016
Trial size 50 participants
Trial identifier NCT02805712, 2014P001391

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(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.
control
The control group will receive usual written care material and a palliative care consult if ordered by physician.
(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.
verbal 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.

Primary Outcomes

Measure
Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?
time frame: Three months

Secondary Outcomes

Measure
Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?
time frame: 3 months
Is there an impact on symptom burden through a palliative care intervention?
time frame: Three months
Is there an impact on perceived level of illness through a palliative care intervention?
time frame: Three months
Is there an impact on overall patient well being through a palliative care intervention?
time frame: Three months
Is there an impact on depression through a palliative care intervention?
time frame: Three months
Is there an impact on anxiety through a palliative care intervention?
time frame: Three months
Is there an impact on cost of treatment through a palliative care intervention?
time frame: Three months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Study of a Focused Palliative Care Intervention for Recently Hospitalized High-Risk Patients With Heart Failure
Principal investigator Akshay S Desai, MPH, MD
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 three month visit (Final 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.