Heart FailureNCT05388097
Effect of a Quality Improvement Initiative to Address Social Determinants of Health on Rehospitalization Rates in Patients With Heart Failure
A study testing Managed Services in people with Heart Failure, run by Saint Luke's Health System at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Managed Services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 May 2021to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-99 years
- Resident of Missouri or Kansas
- Current inpatient admission for acute heart failure
Who cannot join
- Under 18 years or over 99 years of age
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
University Health Truman Medical Center
Kansas City, Missouri, 64108
Niccole Neal, RN, BSN, 816-404-1275, niccole.neal@uhkc.org
Angel Lopez-Candales, MD
- Not yet recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Evelyn Dean, 816-932-5330, edean@saint-lukes.org
Stacy Farr, PhD
- Recruiting
Olathe Health System
Olathe, Kansas, 66061
Diedre Lammers, RN, 913-355-4190
Dusan M Stanojevic, MD
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Managed Services
- Keywords
- heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managed ServicesOther
coordination of care and assistance with community resources (food, transportation)
| Study group | Role | What they receive |
|---|---|---|
| Standard Of Care - No Managed Services | No intervention | Subjects receive standard medical care and follow-up after hospital discharge |
| Managed Services After Discharge | Experimental | Subjects receive in-home assessment and care coordination/connection with community resources after hospital discharge Receives: Other: Managed Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in all-cause re-hospitalization
reduction in all-cause re-hospitalization via improved post-acute care coordination
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start3 May 2021
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Truman Medical Center, University of Missouri, Kansas City, Mid America Regional Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388097
- Sponsor's protocol ID
- Managed Services Network
- Status last verified
- Jun 2024
- First submitted
- 27 Apr 2022
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Strategy for Addressing Social Barriers to a Successful, Sustained Discharge From the Hospital for Acute Heart Failure
- ClinicalTrials.gov ID
- NCT05388097
- Acronym / sponsor ID
- Managed Services Network
- Conditions
- Heart Failure
- Keywords
- heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- Truman Medical Center, University of Missouri, Kansas City, Mid America Regional Council
- Study start
- 3 May 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Of Care - No Managed Services | No intervention | –Subjects receive standard medical care and follow-up after hospital discharge |
| Managed Services After Discharge | Experimental | Other: Managed ServicesSubjects receive in-home assessment and care coordination/connection with community resources after hospital discharge |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-99 years
- Resident of Missouri or Kansas
- Current inpatient admission for acute heart failure
Key exclusion criteria (1 listed)
- Under 18 years or over 99 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Managed Servicescoordination of care and assistance with community resources (food, transportation) | Other | Managed Services After Discharge |
Primary outcome
Reduction in all-cause re-hospitalization
Time frame: 2 years
reduction in all-cause re-hospitalization via improved post-acute care coordination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Curators of the University of Missouri. University of Missouri-Kansas City Community Connect: Doing More Together.Link provided by the sponsor.
- University of Missouri-Kansas City (UMKC). School of Education.Link provided by the sponsor.
- Truman Medical Centers-Health Sciences District. Community Health Needs Assessment. June 2019.Link provided by the sponsor.
- Truman Medical Center FoundationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Managed Services in people with Heart Failure, run by Saint Luke's Health System at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stacy Farr, PhD (816-932-5846, sfarr@saint-lukes.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in all-cause re-hospitalization (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.