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

Heart Failure Clinical Trial

— THRIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524534
• Other study ID #: CN-16-2667
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: June 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2091
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	The Permanente Medical Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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