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- Registre américain des essais cliniques
- Essai clinique NCT07716202
Homeless Overdose Prevention- Expansion (HOPE)
Homeless Overdose Prevention- Expansion (HOPE) (QUE 25-014)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The proposed HOPE project builds on the Phase 1 implementation trial at 6 Veterans Health Administration health care systems (part of the current Bridge QUERI). This trial evaluated a 6-month implementation approach that was tailored based on the determinants identified for each of the Housing and Urban Development-VA Supportive Housing (HUD-VASH) teams as part of pre-implementation formative evaluations at each site. During the Phase 1 HOPE trial, HUD-VASH case managers reached more than 1700 HUD-VASH Veterans at risk for opioid overdose, providing education about their risk and naloxone to those who accepted the prescription. The implementation trial was conducted with 33 HUD-VASH teams at 6 low performing VISN 21 sites selected in partnership with regional HUD-VASH leadership. Approximately 300 HUD-VASH social workers were trained on OEND. Five of the 6 healthcare systems also became high performers (i.e., above the national average for naloxone receipt across all VA healthcare systems).
Phase 2 of the HOPE trial will rely on the core evidence-based practice (EBP) of OEND, including identifying community-based naloxone resources, but the investigators will also provide each HUD-VASH team education and training regarding xylazine (including how it may increase opioid-overdose mortality risk) and fentanyl test strips. The latter is particularly important given that the investigators will identify community partnerships for receipt of confidential OEND since many non-VA harm reduction services do offer drug test strips. Also, drug test strips are prohibited in certain states that identify them as illegal drug paraphernalia. States are regularly revisiting these laws, and the investigators will update each implementation site about the current status of laws regarding drug test strips as part of implementation.
In Phase 2 of the HOPE trial, the investigators will evaluate the use of an Implementation Playbook developed during HOPE's Phase 1 implementation trial. The Low Intensity (LI) implementation approach will include providing sites with the HOPE Implementation Playbook, including access to the associated resources (e.g., OEND note templates) on the HOPE SharePoint site. The investigators will begin with an initial training session with each site, and investigators will lead a monthly learning collaborative for 6 months. The LI phase will allow investigators to evaluate the effect of a comprehensive playbook on uptake of OEND. The High Intensity (HI) approach, led by investigators, includes: (1) creation of a novel clinical team (i.e., prescriber and HUD-VASH team) if not created under LI; (2) monthly overdose education and training delivered synchronously via MS Teams; (3) monthly audit and feedback for each HUD-VASH team on progress toward providing OEND; and (4) technical assistance.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Amanda M Midboe, PhD
- Numéro de téléphone: 27829 (650) 493-5000
- E-mail: Amanda.Midboe@va.gov
Sauvegarde des contacts de l'étude
- Nom: Madeleine C Golding, MPH BA
- Numéro de téléphone: 27422 (650) 614-9997
- E-mail: madeleine.golding@va.gov
Lieux d'étude
-
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California
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Palo Alto, California, États-Unis, 94304-1207
- VA Palo Alto Health Care System, Palo Alto, CA
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Veterans enrolled in HUD-VASH at risk for opioid overdose (based on existing HOPE algorithms aligned with Pharmacy Benefit Manager data definitions), drawing from VA administrative data.
Exclusion Criteria:
- Not flagged by existing HOPE algorithms
- Not currently enrolled in HUD-VASH
- Is not a patient at a participating site of the implementation trial
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Low-Intensity (LI)
The LI implementation approach will include providing sites with the HOPE Implementation Playbook, including access to the associated resources (e.g., OEND note templates) on the HOPE SharePoint site.
Investigators will begin with an initial training session with each site, and lead a monthly learning collaborative for 6 months.
The LI phase will allow evaluation of the effect of a comprehensive playbook on uptake of OEND.
|
Homeless Overdose Prevention - Expansion (HOPE) tests implementation of overdose education and naloxone distribution (OEND), a program that targets homeless experienced Veterans at risk for overdose, including Veterans in community-based supportive housing.
During pre-implementation, investigators will conduct a rapid qualitative evaluation with 5-10 key informants at each of the identified implementation sites to refine the implementation approach.
Investigators will evaluate low-intensity (LI) vs high-intensity (HI) strategy.
The LI implementation approach will include providing sites with the HOPE Implementation Playbook, including access to the associated resources on the HOPE SharePoint site.
|
|
Comparateur actif: High-Intensity (HI)
The HI approach will include: (1) creation of a novel clinical team (i.e., prescriber and HUD-VASH team) if not created under LI; (2) monthly overdose education and training delivered synchronously via Microsoft Teams; (3) monthly audit and feedback for each HUD-VASH team on progress toward providing OEND; and (4) technical assistance.
Investigators hypothesize the HI implementation strategy will have a greater impact on RE-AIM outcomes.
|
Homeless Overdose Prevention - Expansion (HOPE) tests implementation of overdose education and naloxone distribution (OEND), a program that targets homeless experienced Veterans at risk for overdose, including Veterans in community-based supportive housing.
During pre-implementation, investigators will conduct a rapid qualitative evaluation with 5-10 key informants at each of the identified implementation sites to refine the implementation approach.
Investigators will evaluate low-intensity (LI) vs high-intensity (HI) strategy.
The HI approach includes: (1) creation of a novel clinical team if not created under LI; (2) monthly overdose education and training delivered synchronously via Microsoft Teams; (3) monthly audit and feedback for each HUD-VASH team on progress toward providing OEND; and (4) technical assistance.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reach - VA administrative data
Délai: 12 months
|
Reach will be measured in terms of the proportion of Veterans who receive OEND, including overdose education and/or a naloxone prescription, using VA administrative data.
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12 months
|
|
Adoption - VA administrative data
Délai: 12 months
|
Adoption will be measured in terms of the proportion of VHA pharmacy and other prescriber staff who delivered OEND, using VA administrative data.
|
12 months
|
|
Implementation - Electronic Data Capture
Délai: 12 months
|
Implementation will be measured in terms of adherence of sites to tailored implementation.
Implementation fidelity will be captured using electronic data capture.
|
12 months
|
|
Maintenance - Rapid Qualitative Interviews
Délai: 6-12 months
|
Maintenance will be assessed by the extent to which OEND has become part of routine organizational practices and policies, including clinical processes to maintain OEND.
Maintenance will be assessed 6-12 months post-implementation using semi-structured interviews.
Interviews will be conducted with HUD-VASH staff and measured using rapid qualitative methods and administrative data.
Administrative data will be used to measure whether OEND continues to be provided in the maintenance period.
|
6-12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Effectiveness
Délai: 12 months
|
Among Veterans who received overdose education and/or naloxone, the number of Veterans at-risk of opioid overdose who were hospitalized for an opioid overdose or visited a VA emergency department for an opioid overdose, as measured by VA administrative data.
|
12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Amanda M. Midboe, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- QUX 26-003
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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