- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05312229
Housing Transitions QUERI
February 22, 2024 updated by: VA Office of Research and Development
Implementing and Sustaining Critical Time Intervention (CTI) in Case Management Programs for Homeless-experienced Veterans (PII 21-285)
The VA Grant and Per Diem (GPD) case management aftercare program provides six months of case management for homeless-experienced Veterans undergoing housing transitions.
This Partnered Implementation Initiative (PII) proposes to implement and evaluate Critical Time Intervention (CTI)-an evidence-based, structured, and time-limited case management practice-in 32 GPD case management aftercare sites across the nation.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
The VA Grant and Per Diem case management (GPD-CM) program provides six months of case management for homeless-experienced Veterans (HEVs) undergoing housing transitions.
At present, no specific case management paradigm is required in the GPD-CM program, resulting in practice variation across sites.
This Partnered Implementation Initiative (PII) implements Critical Time Intervention (CTI)-an evidence-based, structured, and time-limited case management practice-at 32 VA GPD-CM sites.
The investigators will use the Replicating Effective Programs (REP) implementation bundle to support CTI implementation at all 32 sites.
Half of these sites will also receive 9 months of external facilitation (enhanced REP) as additional support for CTI implementation.
In a type 3 hybrid trial, the investigators will use mixed methods to examine the impacts of REP versus enhanced REP.
Using trial data, the investigators will develop a business case analysis and implementation playbook for the investigators' program partners to support continued CTI spread and sustainment in the GPD-CM program.
Study Type
Interventional
Enrollment (Estimated)
153
Phase
- Phase 1
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
-
West Los Angeles, California, United States, 90073-1003
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Grant and Per Diem (GPD) case management aftercare grantees in 7 Veterans Integrated Service Networks (VISN), all of whom provide 6-months of case management to Veterans who have experienced homelessness.
Exclusion Criteria:
- None
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Replicating Effective Programs (REP)
A stakeholder-informed training and technical assistance implementation strategy
|
An evidence-based, structured, and time-limited case management practice
Other Names:
A stakeholder-informed training and technical assistance implementation strategy
Other Names:
|
Active Comparator: REP + External Facilitation (Enhanced REP)
REP plus site specific weekly facilitation to support CTI implementation.
|
An evidence-based, structured, and time-limited case management practice
Other Names:
A stakeholder-informed training and technical assistance implementation strategy
Other Names:
Site-specific support to help sites develop tailored plans to implement CTI.
Other Names:
|
No Intervention: Control Group
No CTI implementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fidelity to CTI
Time Frame: 12 months after implementation start
|
% of Sites with adequate fidelity to CTI at 12 months, as measured by the CTI fidelity scale
|
12 months after implementation start
|
Sustainment of CTI
Time Frame: 18 months after implementation start
|
% of Sites with adequate fidelity to CTI at 18 months, as measured by the CTI fidelity scale
|
18 months after implementation start
|
Dollars spent delivering CTI at each site
Time Frame: Between 6 and 18 months after implementation start
|
Case manager salary and benefits
|
Between 6 and 18 months after implementation start
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Housing stability
Time Frame: Between 6 and 18 months after implementation start
|
Days between entry into the GPD case management program and indicator of housing instability
|
Between 6 and 18 months after implementation start
|
Cost of CTI as Implemented
Time Frame: Between 6 and 18 months after implementation start
|
Mean monthly cost of CTI case management per GPD case management Veteran served, compared to the mean monthly cost in the non-CTI GPD case management programs.
|
Between 6 and 18 months after implementation start
|
Hospitalization rates
Time Frame: Between 6 and 18 months after implementation start
|
Number of days between entry into the GPD case management program and hospitalization, number of hospitalizations, number of bed days
|
Between 6 and 18 months after implementation start
|
Cost of Implementation Strategies
Time Frame: Through study completion, 4 years
|
Dollars spent on REP versus enhanced REP
|
Through study completion, 4 years
|
Return on Investment (ROI) of CTI
Time Frame: 6-, 12-, and 18-months after GPD case management program enrollment
|
Dollars saved via improved housing stability and decreased hospitalizations among patients engaged in CTI versus control participants
|
6-, 12-, and 18-months after GPD case management program enrollment
|
Outpatient service use
Time Frame: Between 6 and 18 months after implementation start
|
Number of outpatient appointments
|
Between 6 and 18 months after implementation start
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sonya Emi Gabrielian, MD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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)
October 1, 2021
Primary Completion (Estimated)
September 30, 2025
Study Completion (Estimated)
September 30, 2025
Study Registration Dates
First Submitted
March 10, 2022
First Submitted That Met QC Criteria
April 4, 2022
First Posted (Actual)
April 5, 2022
Study Record Updates
Last Update Posted (Actual)
February 26, 2024
Last Update Submitted That Met QC Criteria
February 22, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- PIX 22-001
- PII 21-285 (Other Grant/Funding Number: QUERI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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