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

This study is currently recruiting participants.
Verified February 2012 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: February 6, 2012
Last verified: February 2012
History of Changes

May 18, 2011
February 6, 2012
October 2011
April 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01360203 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Better Effectiveness After Transition - Heart Failure
Variations in Care: Comparing Heart Failure Care Transition Intervention Effects

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Heart Failure
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
  • 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.
    Intervention: Other: Structured Telephone / Remote Outpatient Monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
August 2013
April 2013   (final data collection date for primary outcome measure)

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 hospice-bound,
  • patients with dementia,
  • patients who are admitted from or we anticipate will be discharged to a skilled nursing facility,
  • patients who do not have a working land line phone or reliable T-mobile 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, expected to enroll in hospice or expire after discharge,
  • patients unable to use the intervention weight scale due to inability to stand or with weight over 390 pounds, or who are otherwise unable to use the intervention equipment.
Both
50 Years and older
No
Contact: Susanne Engel 310-206-1713 sengel@mednet.ucla.edu
United States
 
NCT01360203
R01 HS019311
Yes
Michael Ong, University of California, Los Angeles
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
Principal Investigator: Michael K Ong, MD, PhD University of California, Los Angeles
University of California, Los Angeles
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP