Improving Care of Patients With Heart Failure

Not Applicable

Completed

• Conditions: Depression; Pain; Dyspnea; Quality of Life
• Interventions: Procedure: Symptom Management Service for Heart failure

• Registration Number: NCT01461681
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-28
• Study Start: 2012-03
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symptom Management Service for heart failure	Symptom Management Service for Heart failure	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.

Primary Outcome Measures

Name	Time	Method
Assess change in depression using the Center for Epidemiologic Studies Depression Scale (CES-D)	Outcome measures will be assessed through month 6 post baseline	Outcome measures will be assessed at baseline, 3-months and 6-months The CES-D is a 20-item measure that includes items pertaining to a range of depressive symptoms. Each symptom is assessed 'in the past week' and recorded on a 4-point numeric scale (0= "rarely or none of the time" to 3= "most or all of the time") providing a composite score (range 0 - 60). A score of 16 or higher is generally used to denote the presence of significant depressive symptoms.

Trial Locations

Locations (2)

University of California San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

UCSF Medical Center; 🇺🇸 San Francisco, California, United States