Clinical trial NCT01461681: Improving Care of Patients With Heart Failure
Official title: A Randomized Controlled Trial for Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Pain
Dyspnea
Quality of Life
Keywords: Palliative care
Symptom management
Heart failure
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2011-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Assess change in depression using the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Outcome measures will be assessed through month 6 post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
Study officials:
affiliation: UCSF School of Medicine
name: Steven Z Pantilat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Riordan DL, Rathfon MA, Joseph DM, Hawgood J, Rabow MW, Dracup KA, De Marco T, Pantilat SZ. Feasibility of Implementing a Palliative Care Intervention for People with Heart Failure: Learnings from a Pilot Randomized Clinical Trial. J Palliat Med. 2019 Dec;22(12):1583-1588. doi: 10.1089/jpm.2018.0633. Epub 2019 May 17.