Improving Care of Patients With Heart Failure

NCT ID: NCT01461681

Last Updated: 2014-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-12-31

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.

Conditions

Depression; Pain; Dyspnea; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Symptom Management Service for Heart failure

Intervention Type: PROCEDURE

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.

Usual cardiology 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Symptom Management Service for Heart failure

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.

Intervention Type: PROCEDURE

Other Intervention Names

SMS-HF

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Z Pantilat, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF School of Medicine

Locations

UCSF Medical Center

San Francisco, California, United States

University of California San Francisco Medical Center

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31099698 (View on PubMed)

Other Identifiers

11-06859

Identifier Type: -

Identifier Source: org_study_id