The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study (THRIVE)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telephone Call
In-Person Primary Care Clinical Follow-Up Visit
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Telephone Follow-Up Intervention
In-person follow-up intervention
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Increase in 7-day follow-up rates
To increase follow-up rate within 7 days of discharge to > 90% in eligible patients
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.
Full Information
NCT ID
NCT03524534
First Posted
May 2, 2018
Last Updated
June 9, 2023
Sponsor
Kaiser Permanente
Collaborators
The Permanente Medical Group
1. Study Identification
Unique Protocol Identification Number
NCT03524534
Brief Title
The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study
Acronym
THRIVE
Official Title
The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
The Permanente Medical Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2091 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone Follow-Up Intervention
Arm Type
Active Comparator
Arm Title
In-person follow-up intervention
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Telephone Call
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
In-Person Primary Care Clinical Follow-Up Visit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Readmission for heart failure within 30-days
Description
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.
Time Frame
30 days after discharge
Secondary Outcome Measure Information:
Title
Readmission for any cause within 30 days
Description
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.
Time Frame
30 days after discharge
Title
Increase in 7-day follow-up rates
Description
To increase follow-up rate within 7 days of discharge to > 90% in eligible patients
Time Frame
7 days after discharge
Title
Death from any cause within 30 days
Description
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.
Time Frame
30 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan S. Go, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
32967439
Citation
Lee KK, Thomas RC, Tan TC, Leong TK, Steimle A, Go AS. The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study: A Pragmatic Randomized Trial. Circ Cardiovasc Qual Outcomes. 2020 Oct;13(10):e006553. doi: 10.1161/CIRCOUTCOMES.120.006553. Epub 2020 Sep 24.
Results Reference
derived
Learn more about this trial
The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study
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