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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured Telephone / Remote Outpatient Monitoring
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Davis
  • University of California, Irvine
  • Cedars-Sinai Medical Center
  • University of California, Los Angeles
  • University of California, San Diego
  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Current Care

Care Transition Intervention

Arm Description

Patients will receive the current care provided to heart failure patients at each of the study sites

Care transition intervention beginning prior to discharge and through six months post-discharge.

Outcomes

Primary Outcome Measures

180 day rehospitalization rate
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
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
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
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
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
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
7 day rehospitalization rate
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause

Full Information

First Posted
May 18, 2011
Last Updated
May 10, 2016
Sponsor
University of California, Los Angeles
Collaborators
Cedars-Sinai Medical Center, University of California, Davis, University of California, Irvine, University of California, San Diego, University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01360203
Brief Title
Better Effectiveness After Transition - Heart Failure
Acronym
BEAT-HF
Official Title
Variations in Care: Comparing Heart Failure Care Transition Intervention Effects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Cedars-Sinai Medical Center, University of California, Davis, University of California, Irvine, University of California, San Diego, University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1437 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Current Care
Arm Type
No Intervention
Arm Description
Patients will receive the current care provided to heart failure patients at each of the study sites
Arm Title
Care Transition Intervention
Arm Type
Experimental
Arm Description
Care transition intervention beginning prior to discharge and through six months post-discharge.
Intervention Type
Other
Intervention Name(s)
Structured Telephone / Remote Outpatient Monitoring
Other Intervention Name(s)
Care Transition Intervention, Care Transitions Intervention, Structured Telephone Monitoring, Remote Monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
180 day rehospitalization rate
Description
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
Time Frame
at 180 days post-discharge
Secondary Outcome Measure Information:
Title
7 day mortality rate
Description
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.
Time Frame
within 7 days post-discharge
Title
Change in quality of Life
Description
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
Time Frame
as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge
Title
30 day mortality rate
Description
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.
Time Frame
at 30 days post-discharge
Title
180 day mortality rate
Description
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.
Time Frame
at 180 days post-discharge
Title
30 day rehospitalization rate
Description
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
Time Frame
at 30 days post-discharge
Title
7 day rehospitalization rate
Description
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
Time Frame
within 7 days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael K Ong, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24725308
Citation
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.
Results Reference
background
PubMed Identifier
26857383
Citation
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.
Results Reference
derived

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Better Effectiveness After Transition - Heart Failure

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