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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Telephone Call; Other: In-Person Primary Care Clinical Follow-Up Visit

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.

• Study Type: Interventional
• Enrollment (Actual): 2091
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Telephone Follow-Up Intervention	Other: Telephone Call; 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.
Active Comparator: In-person follow-up intervention	Other: In-Person Primary Care Clinical Follow-Up Visit; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: The Permanente Medical Group
• Investigators: Principal Investigator: Alan S. Go, MD, Kaiser Permanente

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CN-16-2667

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No