- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03969238
Utilizing Helpline for Opioid Dependence Treatment
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The proposed specific aims are to:
- Test if the helpline is a resourceful tool for patients with opioid use disorder looking for referrals and support to access treatment. The opioid helpline will provide individuals with opioid use disorder seeking treatment, direct access to a live person who can answer questions regarding referrals and various treatment programs. The helpline will also follow-up on treatment compliance and offer support and motivational techniques for these individuals to stay engaged in treatment
- Test if the helpline is a resourceful tool for patients with new onset of pain or chronic pain being prescribed opioids. The opioid helpline will provide these individuals the necessary educational materials on managing pain safely while avoiding misuse. It will offer free imagery guided meditation and other non-pharmacological tools to help with pain management.
- Test if providers find the opioid helpline helpful and resourceful for their practice and are willing to refer patients to the helpline.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22903
- Reclutamiento
- UVA Center for Leading Edge Addiction Research
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Contacto:
- Eva Jenkins-Mendoza
- Número de teléfono: (434)243-0562
- Correo electrónico: emj9c@virginia.edu
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Contacto:
- Tracie Kostelac
- Número de teléfono: 434-243-0563
- Correo electrónico: tlk5d@virginia.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
We plan to pilot this model in a small rural area with low accessibility to specialized treatment. We will specifically target the area of county of Wise as it is an area with one of the highest rate of opioid addiction and overdose related deaths in the state.
UVA hospital: we plan to pilot this model at UVA hospital because it is a health care system offering care to a diverse population from urban and rural areas.
The providers will be educated regarding the goals and objectives of the helpline: Any specialty physicians, nurses including dentists that prescribes opioids within Virginia They will be asked to have flyers about the helpline in their office and refer patients who are prescribed opioids to get more support from the helpline.
Descripción
Inclusion Criteria:
Participant Criteria:
- Age greater than or equal to 18 years.
- A formal diagnosis of Opioid Use Disorder (OUD) by a health care provider or
- If no formal diagnosis of OUD, having a self-reported concern with opioid use or addiction.
- An individual seeking to reduce opioid use.
- An individual concerned about opioids prescribed for management of new-onset pain or chronic pain.
Provider Criteria:
- University of Virginia: Providers of any specialties within VA including dentists that prescribes opioids.
- County of Wise: Providers of any specialties including dentists that prescribes opioids.
Exclusion Criteria:
Participant Criteria:
- Individuals under 18 years of age.
- Individuals seeking treatment for non-opioid substance use disorders
- Individuals who have no pain issues
- Individuals located outside of Virginia.
Provider Criteria:
Providers outside the designated regions.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Patients/Providers
Of the1,000 participants: (1) 900 will enroll as participants who use the helpline resources via verbal consent and (2) 100 will enroll as providers via online consent prior to survey data collection.
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This helpline will aim to provide patients with new diagnosis of pain who are prescribed opioids, access to education, support and free behavioral technique to help manage their pain such as mindfulness exercises.
For those with opioid use disorder, the helpline will offer support in the form of education about the disorder, opioid withdrawal symptoms, risks of overdoses, and a variety of services such as help reach appropriate care with MAT licensed providers, information on FDA-approved MAT and naloxone, and, in some cases, behavioral intervention to keep patients engaged in treatment.
The opioid helpline will provide a central resource for direct services and a portal for community services.
It will also serve as a referral resource for health-care professionals.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Participant Opioid Helpline Survey
Periodo de tiempo: up to a year
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Primary outcomes measure the rating of the Helpline by the patients.
They will be sent surveys that will ask the patients to rate the services they receive on a scale of 1 to 10, with 1 meaning they are very dissatisfied and 10 meaning they are very satisfied.
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up to a year
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Provider Opioid Helpline Survey
Periodo de tiempo: up to a year
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Primary outcomes measure the rating of the Helpline by the providers.
They will be sent surveys that will ask the providers to rate the services they receive on a scale of 1 to 10, with 1 meaning they are very dissatisfied and 10 meaning they are very satisfied.
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up to a year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of participants reached versus called.
Periodo de tiempo: up to a year
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Total number of contacts to the Helpline compared to the number that prescreened and the number consented.
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up to a year
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Number of participants who continued to access the services of Helpline
Periodo de tiempo: up to a year
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The investigator will measure the number of participants who continued to access the services of Helpline up to a year.
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up to a year
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New General Self-Efficacy Measure
Periodo de tiempo: up to a year
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By using this survey, the investigator will determine the participant's ability to handle the situation that prompted the participant to call the Helpline originally.
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up to a year
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Opioid Helpline Study Screen Form
Periodo de tiempo: up to a year
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This will be use to collect demographic information for individuals who self-identify as needing help or resources from the Helpline.
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up to a year
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Referral follow-ups
Periodo de tiempo: up to a year
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Assess which referrals were followed up on by the participants.
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up to a year
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 21376
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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