Clinical trial NCT03524534: The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study
Official title: The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: The Permanente Medical Group
First posted: 2018-05-15
Enrollment: 2091
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Readmission for heart failure within 30-days
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Readmission for any cause within 30 days
timeFrame: 30 days after discharge
measure: Increase in 7-day follow-up rates
timeFrame: 7 days after discharge
measure: Death from any cause within 30 days
timeFrame: 30 days after discharge
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Alan S. Go, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.