Heart Failure
Conditions
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.
Interventions
OTHERStructured 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.
Sponsors
Cedars-Sinai Medical Center
University of California, Davis
University of California, Irvine
University of California, San Diego
University of California, San Francisco
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 180 day rehospitalization rate | at 180 days post-discharge | Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of Life | as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge | 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 | at 30 days post-discharge | 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. |
| 7 day mortality rate | within 7 days post-discharge | 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 | at 30 days post-discharge | Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause |
| 7 day rehospitalization rate | within 7 days post-discharge | Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause |
| 180 day mortality rate | at 180 days post-discharge | 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. |
Countries
United States
Outcome results
None listed