The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study

Study Overview
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Brief Summary
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This study is a pragmatic randomized clinical trial to determine the effectiveness of two strategies of early follow-up in adults after hospitalization for heart failure: telephone follow-up with a heart failure care manager vs. in-person clinic visit with their primary care provider. The primary outcomes during 30-day follow-up will include readmission for heart failure, death and readmission for any cause. The study team aims to randomly assign 2400 patients during a 15-month period in a 1-to-1 ratio to either an initial structured telephone call with a heart failure care manager or an in-person primary care clinic visit within 7 days of discharge. A secondary goal is to increase the rate of any follow-up within 7 days of discharge to greater than 90 percent among all eligible patients.

Detailed Description
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Heart failure (HF) affects >5 million adults nationally and is the leading cause of hospitalization among Medicare beneficiaries. Reducing hospitalization for heart failure (HF) and subsequent readmissions shortly after discharge is a nationally recognized health care delivery system priority. More than 20% of Medicare patients hospitalized for HF are readmitted within 30 days and this rate has not been declining over the past decade despite increasing attention to this problem. The data that will be collected could allow the study team to tailor the post-discharge follow-up program to patient characteristics to further improve the effectiveness of the interventions.

Official Title
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The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Telephone Call
* Other: In-Person Primary Care Clinical Follow-Up Visit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All eligible patients hospitalized for confirmed acute heart failure at a Kaiser Permanente Northern California medical center Exclusion Criteria: Planned discharge to a location other than their home. This includes a skilled nursing facility, nursing home or hospice facility. Planned discharge to home with hospice care. End-stage renal disease treated with chronic peritoneal dialysis or hemodialysis. Death during the index hospitalization.

Ages Eligible for Study
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Minimum Age: 21 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telephone Follow-Up Intervention<br> | Other: Telephone Call<br>* A phone call will take place within 7 days of discharge by a Kaiser Permanente Heart Failure Care Manager from the Kaiser Permanente Heart Failure Chronic Care Management Program.<br>|
| Active Comparator: In-person follow-up intervention<br> | Other: In-Person Primary Care Clinical Follow-Up Visit<br>* This will be a standard in-person clinic visit with the subject's primary care physician within 7 days of discharge, with no structured heart failure protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission for heart failure within 30-days | To compare 30-day rates of heart failure-related readmission for subjects randomly assigned to initial heart failure care manager telephone visit vs. in-person primary care clinic visit within 7 days after discharge from a heart failure hospitalization. | 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission for any cause within 30 days | To compare 30-day rates of readmission for any cause for subjects randomly assigned to initial heart failure care manager telephone visit vs. in-person primary care clinic visit within 7 days after discharge from a heart failure hospitalization. | 30 days after discharge | 
| Increase in 7-day follow-up rates | To increase follow-up rate within 7 days of discharge to > 90% in eligible patients | 7 days after discharge | 
| Death from any cause within 30 days | To compare 30-day rates of death from any cause for subjects randomly assigned to initial heart failure care manager telephone visit vs. in-person primary care clinic visit within 7 days after discharge from a heart failure hospitalization. | 30 days after discharge |