Improving Care of Patients With Heart Failure
A Randomized Controlled Trial for Patients With Heart Failure
1 other identifier
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Mar 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
October 28, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 14, 2014
May 1, 2014
1.5 years
October 17, 2011
May 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess change in depression using the Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Outcome measures will be assessed through month 6 post baseline
Study Arms (2)
Symptom Management Service for heart failure
EXPERIMENTALSubjects 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.
Usual cardiology care
NO INTERVENTIONThe 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.
Interventions
The symptom management service for heart failure (SMS-HF) will begin in the hospital where the patient will be seen daily until discharge and continue with at least 6 contacts over the next 6 months with the first outpatient contact occurring in person in the HF clinic within a month of discharge. Of the subsequent 5 monthly contacts, at least 2 will be in person with the remainder by telephone. Additional contacts between the SMS-HF team and patient will be scheduled as needed. Patients discharged to a site other than home will have monthly contacts by telephone until they are able to attend the clinic. We will assess changes in depression, pain, dyspnea, and quality of life from baseline to 6 month follow-up.
Eligibility Criteria
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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UCSF Medical Center
San Francisco, California, 94143, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
Related Publications (1)
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.
PMID: 31099698DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Z Pantilat, MD
UCSF School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2011
First Posted
October 28, 2011
Study Start
March 1, 2012
Primary Completion
September 1, 2013
Study Completion
December 1, 2013
Last Updated
May 14, 2014
Record last verified: 2014-05