Improving Care of Patients With Heart Failure

University of California San Francisco (UCSF)

Status: Completed

Conditions: Dyspnea; Quality of Life; Depression; Pain

Treatments: Procedure: Symptom Management Service for Heart failure

Study type: Interventional

Funder types: Other

Identifiers

NCT01461681

11-06859

Details and patient eligibility

About

Heart failure (HF) affects more than 5 million Americans and is a major source of morbidity and mortality. Despite optimal management, over half of patients with HF suffer from pain, dyspnea, fatigue, and depression that diminish quality of life (QoL). HF care also exacts a huge financial toll with yearly costs of $35 billion. Although consensus guidelines call for providing palliative care (PC) to patients with HF to relieve suffering and improve QoL, few receive it. The overall aim of this project is to conduct a randomized controlled trial (RCT) to determine if an interdisciplinary PC intervention (Symptom Management Service-HF [SMS-HF]) provided concurrently with standard cardiology care improves symptoms, QoL and satisfaction, and reduces resource utilization in outpatients with Class II-IV HF compared to standard cardiology care alone. Subjects assigned to the SMS-HF group will receive a 6-month interdisciplinary PC intervention based on the investigators successful SMS model of outpatient PC for oncology patients and focused on assessment and management of physical, emotional, social, and spiritual distress and discussion of treatment preferences. Innovations of this study are that it will rigorously assess the impact of the SMS-HF on patient outcomes and on resource utilization, a key component to ensuring program sustainability. The investigators research team of PC and HF experts is recognized for its PC research and has a proven record of collaborating, conducting RCTs of PC interventions, and studying outpatients with HF. The environment at UCSF is highly supportive of innovative research and of sustaining programs with demonstrated improvements in patient outcomes and operational effectiveness. The overall goal is to use the results from this study to support an application to the NIH for a multi-center RCT of the SMS-HF and to study similar models of concurrent PC for patients with other serious illnesses.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• HF as primary Dx or symptomatic/active HF
• During index hospitalization or within the prior 6 months
• Age > 18
• Admit from: hospital, skilled nursing, home
• Medicine, Cardiology, and Heart Failure Services
• Co-morbidities can include end-stage renal disease, metastatic cancer, ICU/CCU care patients if able to consent and complete survey
• English speaking

Exclusion Criteria:

• Non-English speaking
• Previous consult by Palliative Care Service
• Pulmonary HTN
• Right Heart Failure
• LVAD
• PCI or CABG patient within this admission
• AS with planned surgical intervention
• Pre/post heart transplant
• Pre/post organ transplant within this admission
• Dementia (unable to consent)
• Homeless
• Active drug user
• Hospice enrolled patient
• GeriTraCC patients
• Does not have a UCSF physician
• Lives outside of the SF Bay Area

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Symptom Management Service for heart failure

Experimental group

Description:

Subjects randomized to the SMS-HF group will receive a comprehensive PC consultation by the interdisciplinary PC team at each site consisting of a nurse practitioner, physician, social worker and chaplain with 6 months of follow up. All members of the PC team are experienced PC clinicians. The SMS-HF intervention is based on National Quality Forum preferred practices and the National Consensus Project guidelines for quality PC. The SMS-HF will include assessment and management of symptoms, particularly focused on depression, pain and dyspnea, and a discussion of goals of care.

Treatment:

Procedure: Symptom Management Service for Heart failure

Usual cardiology care

No Intervention group

Description:

The usual cardiology care group will receive usual care provided by the HF clinic. We will assess symptoms and QoL at enrollment and symptoms, QoL, satisfaction, advance care planning documentation, and resource utilization at follow up 6 months later.