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

This study has been completed.
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: May 7, 2014
Last verified: May 2014
  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


Enrollment: 1437
Study Start Date: October 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360203

Locations
United States, California
University of California, Davis
Davis, California, United States, 95616
University of California, Irvine
Irvine, California, United States, 92697
University of California, Los Angeles
Los Angeles, California, United States, 90095
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, San Diego
San Diego, California, United States, 92093
University of California, San Francisco
San Francisco, California, United States, 94143
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

Publications:
Responsible Party: Michael Ong, Associate 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: May 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014