Better Effectiveness After Transition - Heart Failure (BEAT-HF)

This study is currently recruiting participants.
Verified August 2013 by University of California, Los Angeles
Sponsor:
Collaborators:
Cedars-Sinai Medical Center
University of California, Davis
University of California, Irvine
University of California, San Diego
University of California, San Francisco
Information provided by (Responsible Party):
Michael Ong, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01360203
First received: May 18, 2011
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to compare the effect of implementing wireless remote monitoring combined with structured telephone monitoring, versus current care, on variation in rehospitalization among older patients hospitalized with heart failure at six medical centers.


Condition Intervention
Heart Failure
Other: Structured Telephone / Remote Outpatient Monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Variations in Care: Comparing Heart Failure Care Transition Intervention Effects

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 180 day rehospitalization rate [ Time Frame: at 180 days post-discharge ] [ Designated as safety issue: No ]
    Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause


Secondary Outcome Measures:
  • 7 day mortality rate [ Time Frame: within 7 days post-discharge ] [ Designated as safety issue: No ]
    Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.

  • Change in quality of Life [ Time Frame: as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge ] [ Designated as safety issue: No ]
    Quality of life scores will be measured using standardized questionnaires, and data captured during enrollment will be compared with data captured during three post-discharge phone calls

  • 30 day mortality rate [ Time Frame: at 30 days post-discharge ] [ Designated as safety issue: No ]
    Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.

  • 180 day mortality rate [ Time Frame: at 180 days post-discharge ] [ Designated as safety issue: No ]
    Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.

  • 30 day rehospitalization rate [ Time Frame: at 30 days post-discharge ] [ Designated as safety issue: No ]
    Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause

  • 7 day rehospitalization rate [ Time Frame: within 7 days post-discharge ] [ Designated as safety issue: No ]
    Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause


Estimated Enrollment: 1500
Study Start Date: October 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Current Care
Patients will receive the current care provided to heart failure patients at each of the study sites
Experimental: Care Transition Intervention
Care transition intervention beginning prior to discharge and through six months post-discharge.
Other: Structured Telephone / Remote Outpatient Monitoring
During their hospitalization, patients will receive education on their condition and will be taught to use a wireless remote monitoring device that they will use from home on a daily basis for six months following hospital discharge. Patients will receive structured telephone phone calls from a centralized call center nurse at least once a week for the first month post-discharge, and monthly for the remainder of the six month study period. Patients may receive additional calls depending upon the information gathered during the scheduled call center phone calls and/or their health status as ascertained by the data (weight, heart rate, blood pressure, answers to general health and heart failure-related questions) transmitted daily by the wireless remote monitoring device.
Other Names:
  • Care Transition Intervention
  • Care Transitions Intervention
  • Structured Telephone Monitoring
  • Remote Monitoring

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients hospitalized at any of the six medical centers who are being actively treated for heart failure.

Exclusion Criteria:

  • patients who have previously received a transplant, are being evaluated for a transplant, or who are on the wait list for a transplant,
  • patients who are enrolled or enrolling in hospice, or are expected to expire shortly after discharge,
  • patients with dementia,
  • patients who are admitted from a skilled nursing facility (SNF), or who we anticipate will be discharged to a long term stay in a SNF,
  • patients who do not have a working land line phone or reliable cell service,
  • patients on chronic dialysis,
  • patients who cannot identify a usual source of care (free clinic is acceptable) and who will not be assigned a provider upon discharge,
  • patients with the following cardiovascular conditions: patients with valvular disorders requiring surgical intervention (except for those with incidental valvular disease, who will be included), acute myocardial infarction (except for those with demand ischemia, who will be included), percutaneous coronary intervention
  • patients expected to enroll in hospice or expire after discharge,
  • patients who are unable to use the intervention equipment (e.g., unable to stand on the weight scale), or who are otherwise unable to comply with the intervention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360203

Contacts
Contact: Susanne Engel 310-206-1713 sengel@mednet.ucla.edu

Locations
United States, California
University of California, Davis Recruiting
Davis, California, United States, 95616
Contact: Meghan Soulsby       masoulsby@ucdavis.edu   
Principal Investigator: Patrick S Romano, MD, MPH         
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Elizabeth Michel       emichel@uci.edu   
Principal Investigator: Sheldon Greenfield, MD         
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Susanne Engel    310-794-1054    sengel@mednet.ucla.edu   
Principal Investigator: Michael K Ong, MD, PhD         
Principal Investigator: Carol M Mangione, MD, MSPH         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Dana Fine       dana.fine@cshs.org   
Principal Investigator: Bruce N Davidson, PhD, MPH         
Principal Investigator: Jeanne T Black, PhD, MBA         
University of California, San Diego Recruiting
San Diego, California, United States, 92093
Contact: Wendy Davila       wdavila@ucsd.edu   
Principal Investigator: Theodore G Ganiats, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Andrew D Auerbach       ada@medicine.ucsf.edu   
Principal Investigator: Andrew D Auerbach, MD, MPH         
Sponsors and Collaborators
University of California, Los Angeles
Cedars-Sinai Medical Center
University of California, Davis
University of California, Irvine
University of California, San Diego
University of California, San Francisco
Investigators
Principal Investigator: Michael K Ong, MD, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Michael Ong, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01360203     History of Changes
Other Study ID Numbers: R01 HS019311
Study First Received: May 18, 2011
Last Updated: August 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014