- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05807750
Effects Of Income Supplements On 30-Day Readmissions For Vulnerable Older Adults
May 31, 2024 updated by: AltaMed Health Services Corporation
Effects Of Income Supplements On 30-Day Readmissions For Vulnerable Older Adults: A Randomized, Controlled, 300-Subject Clinical Trial
Unplanned 30-day hospital readmissions are an critical healthcare quality metric, with meaningful effects on patients and health systems operations.
Interventions to reduce unplanned readmissions have primarily operated within a healthcare-centric frame, with enhancements to either pre- or post-discharge care planning, medication reconciliation, or visit frequency.
Associations of 30-day readmission rates with poverty status and other social factors, however, suggest that attending to unmet social needs may yield added benefits to models focused on healthcare delivery.
The purpose of the present trial is to provide evidence regarding the effects on 30-day readmissions of providing a one-time post-discharge income supplement to socially vulnerable older adults with medical complexity participating in an enhanced care coordination program.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
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 Locations
-
-
California
-
Los Angeles, California, United States, 90040
- AltaMed Health Services Corporation
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- A participant in the underlying enhanced care planning program
- aged 55 years or older
- attending an outpatient clinic appointment as part of the underlying enhanced care planning program within 10 days of being discharged from an inpatient hospital stay
- able to understand the study consent form (with interpretation services if needed)
Exclusion Criteria:
- The candidate is not discharged from the index admission to a community setting (e.g., they will be excluded if they are discharged to a skilled nursing facility)
- The candidate has a legal guardian with control over financial decision-making
- The candidate has been approached about the study during a previous encounter
- The index hospitalization was a planned admission
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Enhanced care planning only (plus $15 as compensation for participation)
|
Enhanced care planning provided by a nurse care manager
|
|
Experimental: Intervention
Enhanced care planning plus a one-time $300 post-discharge income supplement
|
Enhanced care planning provided by a nurse care manager
$300 income supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unplanned 30-day readmission
Time Frame: Within 30 days of the index hospital discharge
|
Whether a participant has an unplanned readmission within 30 days of the index hospital discharge
|
Within 30 days of the index hospital discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day post-discharge medical expenditures
Time Frame: Within 30 days of the index hospital discharge
|
Total medical expenditures in the 30 days after the index hospital discharge
|
Within 30 days of the index hospital discharge
|
|
90-day post-discharge medical expenditures
Time Frame: Within 90 days of the index hospital discharge
|
Total medical expenditures in the 90 days after the index hospital discharge
|
Within 90 days of the index hospital discharge
|
|
30-day post-discharge medical readmission OR emergency department visit
Time Frame: Within 30 days of the index hospital discharge
|
Whether a participant has an unplanned readmission OR emergency department visit within 30 days of the index hospital discharge
|
Within 30 days of the index hospital discharge
|
|
90-day post-discharge medical readmission OR emergency department visit
Time Frame: Within 90 days of the index hospital discharge
|
Whether a participant has an unplanned readmission OR emergency department visit within 90 days of the index hospital discharge
|
Within 90 days of the index hospital discharge
|
|
Unplanned 90-day readmission
Time Frame: Within 90 days of the index hospital discharge
|
Whether a participant has an unplanned readmission within 90 days of the index hospital discharge
|
Within 90 days of the index hospital discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-discharge care plan adherence
Time Frame: Within 90 days of the index hospital discharge
|
Clinic visit attendance, medication fills/refills
|
Within 90 days of the index hospital discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rajan A Sonik, PhD, JD, MPH, Brandeis University
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.
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)
June 21, 2023
Primary Completion (Actual)
April 22, 2024
Study Completion (Actual)
April 22, 2024
Study Registration Dates
First Submitted
March 23, 2023
First Submitted That Met QC Criteria
March 29, 2023
First Posted (Actual)
April 11, 2023
Study Record Updates
Last Update Posted (Actual)
June 3, 2024
Last Update Submitted That Met QC Criteria
May 31, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023-001 Sonik Readmit RCT
- P30AG024968 (U.S. NIH Grant/Contract)
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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