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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telephone Call
In-Person Primary Care Clinical Follow-Up Visit
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Telephone Follow-Up Intervention

    In-person follow-up intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 2, 2018
    Last Updated
    June 9, 2023
    Sponsor
    Kaiser Permanente
    Collaborators
    The Permanente Medical Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03524534
    Brief Title
    The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study
    Acronym
    THRIVE
    Official Title
    The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    September 2018 (Actual)
    Study Completion Date
    December 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaiser Permanente
    Collaborators
    The Permanente Medical Group

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2091 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Telephone Follow-Up Intervention
    Arm Type
    Active Comparator
    Arm Title
    In-person follow-up intervention
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Telephone Call
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    In-Person Primary Care Clinical Follow-Up Visit
    Intervention Description
    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 Outcome Measure Information:
    Title
    Readmission for heart failure within 30-days
    Description
    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.
    Time Frame
    30 days after discharge
    Secondary Outcome Measure Information:
    Title
    Readmission for any cause within 30 days
    Description
    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.
    Time Frame
    30 days after discharge
    Title
    Increase in 7-day follow-up rates
    Description
    To increase follow-up rate within 7 days of discharge to > 90% in eligible patients
    Time Frame
    7 days after discharge
    Title
    Death from any cause within 30 days
    Description
    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.
    Time Frame
    30 days after discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alan S. Go, MD
    Organizational Affiliation
    Kaiser Permanente
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32967439
    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.
    Results Reference
    derived

    Learn more about this trial

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

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