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NCT Number: NCT03524534

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Readmission for heart failure within 30-days

    Time frame: 30 days after discharge

    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.

Secondary outcomes

  1. Readmission for any cause within 30 days

    Time frame: 30 days after discharge

    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.

  2. Increase in 7-day follow-up rates

    Time frame: 7 days after discharge

    To increase follow-up rate within 7 days of discharge to > 90% in eligible patients

  3. Death from any cause within 30 days

    Time frame: 30 days after discharge

    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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • The Permanente Medical Group

Registry information

Acronym: THRIVE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 15, 2018
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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