Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder (ED-CONNECT)
28 de agosto de 2019 actualizado por: 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:
- To evaluate using mixed methods the feasibility and acceptability of OUD screening, ED-initiated BUP, and referral.
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
390
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New Hampshire
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Claremont, New Hampshire, Estados Unidos, 03743
- Valley Regional Healthcare
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Manchester, New Hampshire, Estados Unidos, 03102
- Catholic Medical Center
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New York
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New York, New York, Estados Unidos, 10016
- New York University School of Medicine
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New York, New York, Estados Unidos, 10016
- Bellevue Hospital Center
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
This will be a three-site study employing a multi-faceted approach to facilitate clinical protocol implementation and to assess feasibility, acceptability, and impact
Descripción
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
- 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.
- 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?
- 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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
ED and OUD treatment providers and staff
|
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.
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|
Community Stakeholders
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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.
|
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.
The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Receipt of ED-initiated BUP (binary) and will be abstracted from the health record.
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Proportion of patients who received ED-initiated BUP who are engaged in formal addiction treatment 30 days after the index ED visit.
Periodo de tiempo: 12 Months
|
12 Months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ryan McCormack, MD, NYU Langone Health
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de junio de 2018
Finalización primaria (Actual)
29 de mayo de 2019
Finalización del estudio (Actual)
29 de mayo de 2019
Fechas de registro del estudio
Enviado por primera vez
21 de mayo de 2018
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2018
Publicado por primera vez (Actual)
1 de junio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de agosto de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
28 de agosto de 2019
Última verificación
1 de agosto de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 17-01513
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .