Better Effectiveness After Transition - Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Variations in Care: Comparing Heart Failure Care Transition Intervention Effects

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Structured Telephone / Remote Outpatient Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Current Care<br>Patients will receive the current care provided to heart failure patients at each of the study sites | |
| Experimental: Care Transition Intervention<br>Care transition intervention beginning prior to discharge and through six months post-discharge. | Other: Structured Telephone / Remote Outpatient Monitoring<br>* 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.<br>* Other names: Remote Monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 180 day rehospitalization rate | Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause | at 180 days post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 7 days post-discharge | 
| 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 | as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge | 
| 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. | at 30 days post-discharge | 
| 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. | at 180 days post-discharge | 
| 30 day rehospitalization rate | Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause | at 30 days post-discharge | 
| 7 day rehospitalization rate | Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause | within 7 days post-discharge |