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Improving Care of Patients With Heart Failure

Primary Purpose

Depression, Pain, Dyspnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Symptom Management Service for Heart failure
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring Palliative care, Symptom management, Heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • UCSF Medical Center
  • University of California San Francisco Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Symptom Management Service for heart failure

Usual cardiology care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2011
Last Updated
May 13, 2014
Sponsor
University of California, San Francisco
Collaborators
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT01461681
Brief Title
Improving Care of Patients With Heart Failure
Official Title
A Randomized Controlled Trial for Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Pain, Dyspnea, Quality of Life
Keywords
Palliative care, Symptom management, Heart failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symptom Management Service for heart failure
Arm Type
Experimental
Arm 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.
Arm Title
Usual cardiology care
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Symptom Management Service for Heart failure
Other Intervention Name(s)
SMS-HF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess change in depression using the Center for Epidemiologic Studies Depression Scale (CES-D)
Description
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.
Time Frame
Outcome measures will be assessed through month 6 post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Z Pantilat, MD
Organizational Affiliation
UCSF School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31099698
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.
Results Reference
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Improving Care of Patients With Heart Failure

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