Focused Palliative Care Intervention in Advanced Heart Failure

NCT ID: NCT02805712

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-12-01

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.

Conditions

Heart Failure; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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

Verbal Information and Discussion

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.

Group Type: EXPERIMENTAL

Verbal Information and Discussion

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Akshay Desai, MD

Director, Heart Failure Disease Management Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akshay S Desai, MPH, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29641819 (View on PubMed)

Other Identifiers

2014P001391

Identifier Type: -

Identifier Source: org_study_id