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HomelessnessPhase 1NCT05312229

Applying a Case Management Model in a VA Homeless Program

A Phase 1 study testing Critical Time Intervention (CTI), External Facilitation and Replicating Effective Programs in people with Homelessness, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Homelessness
What is being tested?
Critical Time Intervention (CTI), External Facilitation and Replicating Effective Programs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteUnited States
Study dates
1 Oct 2021to 30 Sep 2026
Phase
Phase 1
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California, 90073-1003

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Homelessness
Being tested
Critical Time Intervention (CTI), External Facilitation, Replicating Effective Programs
Keywords
Care Management, Homeless, Implementation, Mental Health Care, Quality Assurance, Improvement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Critical Time Intervention (CTI)Behavioural

    Also called CTI

    An evidence-based, structured, and time-limited case management practice

  • External FacilitationOther

    Also called Coaching

    Site-specific support to help sites develop tailored plans to implement critical time intervention (CTI)

  • Replicating Effective ProgramsOther

    Also called REP

    A stakeholder-informed training and technical assistance implementation strategy

Study groups in NCT05312229
Study groupRoleWhat they receive
Replicating Effective Programs (REP)ExperimentalA stakeholder-informed training and technical assistance implementation strategy
Receives: Behavioral: Critical Time Intervention (CTI); Other: Replicating Effective Programs
REP + External Facilitation (Enhanced REP)Active comparatorREP plus site specific weekly facilitation to support critical time intervention (CTI) implementation.
Receives: Behavioral: Critical Time Intervention (CTI); Other: External Facilitation; Other: Replicating Effective Programs
Control GroupNo interventionNo critical time intervention (CTI) implementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fidelity to critical time intervention (CTI)

    % of Sites with adequate fidelity to CTI at 12 months, as measured by the CTI fidelity scale

    Measured: 12 months after implementation start

  2. Sustainment of critical time intervention (CTI)

    % of Sites with adequate fidelity to CTI at 18 months, as measured by the CTI fidelity scale

    Measured: 18 months after implementation start

  3. Dollars spent delivering critical time intervention (CTI) at each site

    Case manager salary and benefits

    Measured: Between 6 and 18 months after implementation start

Secondary outcomes (6)

  1. Housing stability

    Days between entry into the GPD case management program and indicator of housing instability

    Measured: Between 6 and 18 months after implementation start

  2. Cost of critical time intervention (CTI) as Implemented

    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.

    Measured: Between 6 and 18 months after implementation start

  3. Hospitalization rates

    Number of days between entry into the GPD case management program and hospitalization, number of hospitalizations, number of bed days

    Measured: Between 6 and 18 months after implementation start

  4. Cost of Implementation Strategies

    Dollars spent on REP versus enhanced REP

    Measured: Through study completion, 4 years

  5. Return on Investment (ROI) of critical time intervention (CTI)

    Dollars saved via improved housing stability and decreased hospitalizations among patients engaged in CTI versus control participants

    Measured: 6-, 12-, and 18-months after GPD case management program enrollment

  6. Outpatient service use

    Number of outpatient appointments

    Measured: Between 6 and 18 months after implementation start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start1 Oct 2021
  3. Primary completion30 Sep 2026
  4. Study completion30 Sep 2026

Resources

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 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
The investigators are implementing Critical Time Intervention (CTI), an evidence-based, time limited case management practice for individuals experiencing homelessness. The investigators will be randomizing sites receiving CTI into one of two levels of implementation support (low vs. high intensity support). There is no drug, biological/vaccine, or combination product (this is N/A to this project).
Masking
None (open label)
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05312229
Sponsor's protocol ID
PIX 22-001
Other IDs
PII 21-285, 1I50HX003501-01
Status last verified
Oct 2026
First submitted
10 Mar 2022
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Cummings C, Rawal M, Tan G, Finley E, Cordasco KM, Herman D, Edwards L, Gabrielian S. Assessing fidelity to Critical Time Intervention (CTI) for homeless-experienced persons. BMC Health Serv Res. 2026 Jun 16. doi: 10.1186/s12913-026-14939-8. Online ahead of print.

    PubMed 42304402

  • Gabrielian S, Finley EP, Ganz DA, Barnard JM, Jackson NJ, Montgomery AE, Nelson RE, Cordasco KM. Comparing two implementation strategies for implementing and sustaining a case management practice serving homeless-experienced veterans: a protocol for a type 3 hybrid cluster-randomized trial. Implement Sci. 2022 Oct 3;17(1):67. doi: 10.1186/s13012-022-01236-1.

    PubMed 36192785

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Critical Time Intervention (CTI), External Facilitation and Replicating Effective Programs in people with Homelessness, run by VA Office of Research and Development at 1 site 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 1 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: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fidelity to critical time intervention (CTI) (time frame: 12 months after implementation start). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05312229, which also lists 2 linked publications.

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 7 Oct 2026.

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