- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01360203
Better Effectiveness After Transition - Heart Failure (BEAT-HF)
May 10, 2016 updated by: Michael Ong, University of California, Los Angeles
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1437
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Davis, California, United States, 95616
- University of California, Davis
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Irvine, California, United States, 92697
- University of California, Irvine
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Los Angeles, California, United States, 90095
- University of California, Los Angeles
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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San Diego, California, United States, 92093
- University of California, San Diego
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San Francisco, California, United States, 94143
- University of California, San Francisco
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Current Care
Patients will receive the current care provided to heart failure patients at each of the study sites
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Experimental: Care Transition Intervention
Care transition intervention beginning prior to discharge and through six months post-discharge.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
180 day rehospitalization rate
Time Frame: at 180 days post-discharge
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Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
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at 180 days post-discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7 day mortality rate
Time Frame: within 7 days post-discharge
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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.
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within 7 days post-discharge
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Change in quality of Life
Time Frame: as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge
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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
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as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge
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30 day mortality rate
Time Frame: at 30 days post-discharge
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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.
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at 30 days post-discharge
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180 day mortality rate
Time Frame: at 180 days post-discharge
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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.
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at 180 days post-discharge
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30 day rehospitalization rate
Time Frame: at 30 days post-discharge
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Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
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at 30 days post-discharge
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7 day rehospitalization rate
Time Frame: within 7 days post-discharge
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Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
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within 7 days post-discharge
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael K Ong, MD, PhD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Black JT, Romano PS, Sadeghi B, Auerbach AD, Ganiats TG, Greenfield S, Kaplan SH, Ong MK; BEAT-HF Research Group. A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial. Trials. 2014 Apr 13;15:124. doi: 10.1186/1745-6215-15-124.
- Ong MK, Romano PS, Edgington S, Aronow HU, Auerbach AD, Black JT, De Marco T, Escarce JJ, Evangelista LS, Hanna B, Ganiats TG, Greenberg BH, Greenfield S, Kaplan SH, Kimchi A, Liu H, Lombardo D, Mangione CM, Sadeghi B, Sadeghi B, Sarrafzadeh M, Tong K, Fonarow GC; Better Effectiveness After Transition-Heart Failure (BEAT-HF) Research Group. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):310-8. doi: 10.1001/jamainternmed.2015.7712. Erratum In: JAMA Intern Med. 2016 Apr;176(4):568. JAMA Intern Med. 2016 Jun 1;176(6):871.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
May 18, 2011
First Submitted That Met QC Criteria
May 23, 2011
First Posted (Estimate)
May 25, 2011
Study Record Updates
Last Update Posted (Estimate)
May 11, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HS019311 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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