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

Kaiser Permanente

Status: Completed

Conditions: Heart Failure

Treatments: Other: Telephone Call; Other: In-Person Primary Care Clinical Follow-Up Visit

Study type: Interventional

Funder types: Other

Identifiers

NCT03524534

CN-16-2667

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,091 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,091 participants in 2 patient groups

Telephone Follow-Up Intervention

Active Comparator group

Treatment:

Other: Telephone Call

In-person follow-up intervention

Active Comparator group

Treatment:

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