- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05388097
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
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
- Name: Stacy Farr, PhD
- Phone Number: 816-932-5846
- Email: sfarr@saint-lukes.org
Study Contact Backup
- Name: Tracy Breeding
- Phone Number: 816-932-2590
- Email: tbreeding@saint-lukes.org
Study Locations
-
-
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:
- Evelyn Dean
- Phone Number: 816-932-5330
- Email: edean@saint-lukes.org
-
Principal Investigator:
- Stacy Farr, PhD
-
Kansas City, Missouri, United States, 64108
- Recruiting
- University Health Truman Medical Center
-
Contact:
- Niccole Neal, RN, BSN
- Phone Number: 816-404-1275
- Email: niccole.neal@uhkc.org
-
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
|
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.
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
- Curators of the University of Missouri. University of Missouri-Kansas City Community Connect: Doing More Together.
- University of Missouri-Kansas City (UMKC). School of Education.
- Truman Medical Centers-Health Sciences District. Community Health Needs Assessment. June 2019.
- Truman Medical Center Foundation
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.