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

NCT03524534 | Completed

• 1 other identifier: CN-16-2667
• Study Type: interventional
• Target: 2,091
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Readmission for any cause within 30 days

  30 days after discharge

• Increase in 7-day follow-up rates

  7 days after discharge

• Death from any cause within 30 days

  30 days after discharge

Study Arms (2)

Telephone Follow-Up Intervention

ACTIVE COMPARATOR

Other: Telephone Call

In-person follow-up intervention

ACTIVE COMPARATOR

Other: In-Person Primary Care Clinical Follow-Up Visit

Interventions

Telephone Call OTHER

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.

Telephone Follow-Up Intervention

In-Person Primary Care Clinical Follow-Up Visit OTHER

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.

In-person follow-up intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All eligible patients hospitalized for confirmed acute heart failure at a Kaiser Permanente Northern California medical center

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• The Permanente Medical Group: collaborator

Related Publications (1)

• 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.

  PMID: 32967439 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Alan S. Go, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 15, 2018
• Study Start: January 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 12, 2023

Record last verified: 2023-06