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

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:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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:	August 2013
Estimated Primary Completion Date:	April 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

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 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.

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: Elizabeth Zellmer elizabeth.zellmer@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: Laura Linares lrlinares@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:	February 6, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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