Improving Care of Patients With Heart Failure
Completed · Not applicable
Conditions studied: Depression, Pain, Dyspnea, Quality of Life
In brief
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.
Key facts
- Study ID
- NCT01461681
- Run by
- University of California, San Francisco
- People needed
- 30
- Starts
- 2012-03-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2014-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- UCSF Medical Center — San Francisco, California, United States
- University of California San Francisco Medical Center — San Francisco, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.