Effect of a Quality Improvement Initiative to Address Social Determinants of Health on Rehospitalization Rates in Patients With Heart Failure

June 13, 2024 updated by: Saint Luke's Health System

A Novel Strategy for Addressing Social Barriers to a Successful, Sustained Discharge From the Hospital for Acute Heart Failure

The objective of this program is to improve post-acute care coordination for necessary social services for patients leaving the hospital after recovering from an episode of decompensated heart failure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kansas
      • Olathe, Kansas, United States, 66061
        • Recruiting
        • Olathe Health System
        • Contact:
          • Diedre Lammers, RN
          • Phone Number: 913-355-4190
        • Principal Investigator:
          • Dusan M Stanojevic, MD
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Not yet recruiting
        • Saint Luke's Hospital of Kansas City
        • Contact:
        • Principal Investigator:
          • Stacy Farr, PhD
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • University Health Truman Medical Center
        • Contact:
        • Principal Investigator:
          • Angel Lopez-Candales, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18-99 years
  • Resident of Missouri or Kansas
  • Current inpatient admission for acute heart failure

Exclusion Criteria:

  • Under 18 years or over 99 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Of Care - No Managed Services
Subjects receive standard medical care and follow-up after hospital discharge
Experimental: Managed Services After Discharge
Subjects receive in-home assessment and care coordination/connection with community resources after hospital discharge
Other: Managed Services
coordination of care and assistance with community resources (food, transportation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in all-cause re-hospitalization
Time Frame: 2 years
reduction in all-cause re-hospitalization via improved post-acute care coordination
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Luke's Health System

Collaborators

University of Missouri, Kansas City
Truman Medical Center
Mid America Regional Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Managed Services Network

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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