Clinical trial NCT01360203: Better Effectiveness After Transition - Heart Failure
Official title: Variations in Care: Comparing Heart Failure Care Transition Intervention Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
name: University of California, Davis
name: University of California, Irvine
name: University of California, San Diego
name: University of California, San Francisco
First posted: 2011-05-25
Enrollment: 1437
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: 180 day rehospitalization rate
timeFrame: at 180 days post-discharge
Secondary outcomes:
measure: 7 day mortality rate
timeFrame: within 7 days post-discharge
measure: Change in quality of Life
timeFrame: as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge
measure: 30 day mortality rate
timeFrame: at 30 days post-discharge
measure: 180 day mortality rate
timeFrame: at 180 days post-discharge
measure: 30 day rehospitalization rate
timeFrame: at 30 days post-discharge
measure: 7 day rehospitalization rate
timeFrame: within 7 days post-discharge
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Michael K Ong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.