- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05312229
Applying a Case Management Model in a VA Homeless Program
Mise en œuvre et maintien de l'intervention en temps critique (CTI) dans les programmes de gestion de cas pour les anciens combattants sans abri (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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
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California
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West Los Angeles, California, États-Unis, 90073-1003
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Replicating Effective Programs (REP)
A stakeholder-informed training and technical assistance implementation strategy |
An evidence-based, structured, and time-limited case management practice
Autres noms:
A stakeholder-informed training and technical assistance implementation strategy
Autres noms:
|
|
Comparateur actif: REP + External Facilitation (Enhanced REP)
REP plus site specific weekly facilitation to support critical time intervention (CTI) implementation. |
An evidence-based, structured, and time-limited case management practice
Autres noms:
A stakeholder-informed training and technical assistance implementation strategy
Autres noms:
Site-specific support to help sites develop tailored plans to implement critical time intervention (CTI)
Autres noms:
|
|
Aucune intervention: Control Group
No critical time intervention (CTI) implementation |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fidelity to critical time intervention (CTI)
Délai: 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 critical time intervention (CTI)
Délai: 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 critical time intervention (CTI) at each site
Délai: Between 6 and 18 months after implementation start
|
Case manager salary and benefits |
Between 6 and 18 months after implementation start
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Housing stability
Délai: 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 critical time intervention (CTI) as Implemented
Délai: 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
Délai: 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
Délai: Through study completion, 4 years
|
Dollars spent on REP versus enhanced REP |
Through study completion, 4 years
|
|
Return on Investment (ROI) of critical time intervention (CTI)
Délai: 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
Délai: Between 6 and 18 months after implementation start
|
Number of outpatient appointments |
Between 6 and 18 months after implementation start
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Sonya Emi Gabrielian, MD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publications et liens utiles
Publications générales
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- PIX 22-001
- PII 21-285 (Autre subvention/numéro de financement: QUERI)
- 1I50HX003501-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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