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Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder (ED-CONNECT)

28 août 2019 mis à jour par: NYU Langone Health

NIDA CTN-0079: Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder

The purpose of this study is to learn what resources are needed to improve outcomes for patients with opioid use disorder. The study will look at how patients engage in treatment and the decisions that patients and providers make regarding treatment, specifically buprenorphine treatment, for opioid use disorder.

The aims of this study are:

  1. To evaluate using mixed methods the feasibility and acceptability of OUD screening, ED-initiated BUP, and referral.

  2. Over the course of the study and as XR-BUP is added to hospital formularies, to estimate the percentage and confidence intervals of patients assessed, treated, and engaged in treatment at Day 30. This will be a three-site study employing a multi-faceted approach to facilitate clinical protocol implementation and to assess feasibility, acceptability, and impact. Investigators will develop, introduce and update site-specific ED clinical protocols and implementation plans for OUD screening, ED-initiated BUP, and referral for treatment. A participatory action research approach will be utilized along with mixed methods incorporating data derived from:

    • Medical record and administrative data abstraction,
    • Research assessments involving patients who are eligible for and willing to receive ED-initiated BUP (including both those who do, and do not, receive BUP); these assessments will document the index ED visit and the 30th day after the index ED visit,
    • Qualitative interviews, focus groups, and quantitative assessments involving providers and staff, patients, and other stakeholders.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Réel)

390

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • New Hampshire
      • Claremont, New Hampshire, États-Unis, 03743
        • Valley Regional Healthcare
      • Manchester, New Hampshire, États-Unis, 03102
        • Catholic Medical Center
    • New York
      • New York, New York, États-Unis, 10016
        • New York University School of Medicine
      • New York, New York, États-Unis, 10016
        • Bellevue Hospital Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

This will be a three-site study employing a multi-faceted approach to facilitate clinical protocol implementation and to assess feasibility, acceptability, and impact

La description

Inclusion Criteria:

  • ED STAFF: ED/Hospital leadership and staff: Leadership and staff across multiple disciplines (e.g., nurses, social workers, physicians, NPs, PAs, pharmacist, physician and nursing directors) at each ED site will be recruited to participate in the formative evaluation and the IF.
  • PROVIDERS: Community treatment providers/OTP leadership and program staff: Providers, leadership and staff involved in the provision of office-based BUP, community treatment, and/or at opioid treatment programs (OTPs) will be recruited to participate in the formative evaluation and the Implementation Facilitation.
  • COMMUNITY: Other Stakeholders: Other community leaders and members (e.g., EMS, fire department, police, local government leadership, community advocacy groups, etc.) may be recruited to participate in qualitative interviews or focus groups.
  • PATIENTS: ED patients will be recruited to participate in interviews or focus groups.
  • PATIENT-PARTICIPANTS: ED patients who are eligible for and willing to receive ED-initiated BUP will be recruited to participate in two research visits.
  • ALL ED PATIENTS: Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc.

Stakeholder-Participant Inclusion Criteria

  • A member of one of the stakeholder groups (1-4 above)

Patient-Participant Inclusion Criteria

  • Eligible for and willing to receive ED-initiated BUP

    1. Eligibility for ED-initiated BUP is operationally defined as meeting site clinical protocol criteria determined and documented by site clinical staff. See Section 9.2 Clinical Protocol.
    2. Willing to receive ED-initiated BUP is operationally defined as providing an affirmative answer to the following question, which will be embedded in each site's clinical protocol: Would you like to receive buprenorphine today?
    3. NOTE: Patients meeting these criteria, and not meeting exclusion criteria below, may be included as study participants regardless of whether they receive or do not receive ED-initiated BUP

Exclusion Criteria:

Stakeholder-Participant Exclusion Criteria

  • Unwilling or unable to provide consent
  • Currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study

Patient-Participant Exclusion Criteria

  • Not able to speak English sufficiently to understand study procedures and provide written informed consent
  • Unable or unwilling to provide written informed consent or to participate in study procedures
  • Currently receiving any medication treatment for OUD at the time of index ED visit
  • Current research participant in a substance use intervention study or previous participation in the current study
  • Are currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study
  • Inadequate locator information (unable to provide 2 unique means of contact)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
ED and OUD treatment providers and staff
  • ED patients will be recruited to participate in interviews or focus groups.
  • ED patients who are eligible for and willing to receive ED-initiated BUP will be recruited to participate in two research visits.
  • Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc.
Comportemental: Employ a multifaceted approach to facilitate clinical protocol implementation
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation. In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies. The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Community Stakeholders
  • Community treatment providers/OTP leadership and program staff: Providers, leadership and staff involved in the provision of office-based BUP, community treatment, and/or at opioid treatment programs (OTPs) will be recruited to participate in the formative evaluation and the Implementation Facilitation.
  • Other Stakeholders: Other community leaders and members (e.g., EMS, fire department, police, local government leadership, community advocacy groups, etc.) may be recruited to participate in qualitative interviews or focus groups.
Comportemental: Employ a multifaceted approach to facilitate clinical protocol implementation
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation. In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies. The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Patients
ED patients will be recruited to participate in interviews or focus groups.
Comportemental: Employ a multifaceted approach to facilitate clinical protocol implementation
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation. In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies. The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Médicament: Initiate BUP (SL-BUP or XR-BUP) in the ED
The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Receipt of ED-initiated BUP (binary) and will be abstracted from the health record.
Délai: 12 Months
Proportion receiving emergency department BUP amongst patients who have been determined to be eligible for and willing to receive ED-initiated BUP
12 Months

Mesures de résultats secondaires

Mesure des résultats
Délai
Proportion of patients who received ED-initiated BUP who are engaged in formal addiction treatment 30 days after the index ED visit.
Délai: 12 Months
12 Months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

NYU Langone Health

Collaborateurs

National Institute on Drug Abuse (NIDA)

Les enquêteurs

  • Chercheur principal: Ryan McCormack, MD, NYU Langone Health

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 juin 2018

Achèvement primaire (Réel)

29 mai 2019

Achèvement de l'étude (Réel)

29 mai 2019

Dates d'inscription aux études

Première soumission

21 mai 2018

Première soumission répondant aux critères de contrôle qualité

21 mai 2018

Première publication (Réel)

1 juin 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 août 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 août 2019

Dernière vérification

1 août 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 17-01513

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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