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NCT Number: NCT01461681

Improving Care of Patients With Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Medical Center, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Symptom Management Service for Heart failure

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.

Other names: SMS-HF

Primary outcomes

  1. Assess change in depression using the Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: Outcome measures will be assessed through month 6 post baseline

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai

Registry information

Official study title

A Randomized Controlled Trial for Patients With Heart Failure

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 28, 2011
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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