Back to resultsEffect of a Quality Improvement Initiative to Address Social Determinants of Health on Rehospitalization Rates in Patients With Heart Failure
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Managed Services
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring heart failure
Eligibility Criteria
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
Sites / Locations
- Olathe Health SystemRecruiting
- University Health Truman Medical CenterRecruiting
- Saint Luke's Hospital of Kansas City
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Of Care - No Managed Services
Managed Services After Discharge
Arm Description
Subjects receive standard medical care and follow-up after hospital discharge
Subjects receive in-home assessment and care coordination/connection with community resources after hospital discharge
Outcomes
Primary Outcome Measures
Reduction in all-cause re-hospitalization
reduction in all-cause re-hospitalization via improved post-acute care coordination
Secondary Outcome Measures
Full Information
NCT ID
NCT05388097
First Posted
April 27, 2022
Last Updated
April 12, 2023
Sponsor
Saint Luke's Health System
Collaborators
Truman Medical Center, University of Missouri, Kansas City, Mid America Regional Council
1. Study Identification
Unique Protocol Identification Number
NCT05388097
Brief Title
Effect of a Quality Improvement Initiative to Address Social Determinants of Health on Rehospitalization Rates in Patients With Heart Failure
Official Title
A Novel Strategy for Addressing Social Barriers to a Successful, Sustained Discharge From the Hospital for Acute Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Luke's Health System
Collaborators
Truman Medical Center, University of Missouri, Kansas City, Mid America Regional Council
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Of Care - No Managed Services
Arm Type
No Intervention
Arm Description
Subjects receive standard medical care and follow-up after hospital discharge
Arm Title
Managed Services After Discharge
Arm Type
Experimental
Arm Description
Subjects receive in-home assessment and care coordination/connection with community resources after hospital discharge
Intervention Type
Other
Intervention Name(s)
Managed Services
Intervention Description
coordination of care and assistance with community resources (food, transportation)
Primary Outcome Measure Information:
Title
Reduction in all-cause re-hospitalization
Description
reduction in all-cause re-hospitalization via improved post-acute care coordination
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacy Farr, PhD
Phone
816-932-5846
Email
sfarr@saint-lukes.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy Breeding
Phone
816-932-2590
Email
tbreeding@saint-lukes.org
Facility Information:
Facility Name
Olathe Health System
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diedre Lammers, RN
Phone
913-355-4190
First Name & Middle Initial & Last Name & Degree
Dusan M Stanojevic, MD
Facility Name
University Health Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niccole Neal, RN, BSN
Phone
816-404-1275
Email
niccole.neal@uhkc.org
First Name & Middle Initial & Last Name & Degree
Angel Lopez-Candales, MD
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyn Dean
Phone
816-932-5330
Email
edean@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Stacy Farr, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://community.umkc.edu/about/
Description
Curators of the University of Missouri. University of Missouri-Kansas City Community Connect: Doing More Together.
URL
https://education.umkc.edu/outreach-research/
Description
University of Missouri-Kansas City (UMKC). School of Education.
URL
https://res.cloudinary.com/dpmykpsih/image/upload/truman-site-261/media/7535ea7dec474654bdf95f9e7ef463cb/tmc-hospital-hill-2019-final-2.pdf
Description
Truman Medical Centers-Health Sciences District. Community Health Needs Assessment. June 2019.
URL
https://www.tmcgiving.org/our-mission/
Description
Truman Medical Center Foundation
Learn more about this trial
Effect of a Quality Improvement Initiative to Address Social Determinants of Health on Rehospitalization Rates in Patients With Heart Failure
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