Focused Palliative Care Intervention in Advanced Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805712
• Other study ID #: 2014P001391
• Status: Completed
• Phase: N/A
• First received: May 20, 2016
• Last updated: July 19, 2017
• Start date: September 2014
• Est. completion date: December 1, 2016

Study information

• Verified date: July 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

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