Phone Interview to Prevent Recurring Opioid Overdoses (TTIP-PRO)
27 de mayo de 2015 actualizado por: Theresa Winhusen, University of Cincinnati
Pilot Evaluation of the "Tailored Telephone Intervention Delivered by Peers to Prevent Recurring Opioid-Overdoses"
There has been a dramatic rise in opioid overdose (OOD) deaths in recent years.
Attempts to ameliorate the problem have largely focused on increasing the accessibility of naloxone, an opioid antagonist that is effective in OOD reversal.
Individuals who have experienced a non-fatal OOD are at risk for additional overdoses and yet there are no interventions that specifically target this high-risk population.
To address this gap, the investigators have developed the "Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid Overdoses" (TTIP-PRO).
The overall goal of the present study is to conduct a pilot evaluation of the TTIP-PRO.
The research literature suggests the need for an intervention targeting patients experiencing a non-fatal OOD.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single-group, unblinded pilot study of the TTIP-PRO, which will be completed with approximately 30 participants.
Potential participants will be identified by querying the University of Cincinnati Medical Center (UCMC) Emergency Department (ED) Electronic Health Record (EHR) for patients treated for an OOD (e.g., opioid poisoning).
Patients who have experienced an OOD in the past 8 months will be eligible to receive the TTIP-PRO.
A letter about the study will be sent to those patients.
Interested patients will call the UC Health staff working on this study.
A UC Health staff member will inform potential participants about the study, confirm eligibility, collect enrollment measures, and schedule a time for the TTIP-PRO to be completed with the Peer Interventionist.
The participant will be instructed to contact the Peer Interventionist at the scheduled time.
After the peer-delivered TTIP-PRO intervention has been completed, a UC Health employee will contact the participant to administer the follow-up measures.
The UC Health employee will then send a mailing to the participant that will include a copy of the participant's "Personal Risks for Overdose" report, general information about overdose prevention, and information about treatment for opioid use disorder (see section 2.6 for additional information).
The mailing will also include a gift card (which is a standard part of the TTIP-PRO) and an additional gift card to compensate the participant for his/her time as a study participant.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
30
Fase
- No aplica
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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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- 3131 Harvey Avenue, Suite 104
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Cincinnati, Ohio, Estados Unidos, 45229
- UC Physicians Company, LLC Opioid Treatment Program
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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
Descripción
Inclusion Criteria for participants (receiving the TTIP-PRO intervention):
- have been treated for an OOD by the UCMC ED within the prior 8 months
- have used heroin and/or abused prescription opioids in the prior 12 months
- be 18 years of age or older at time of enrollment
- be able to provide verbal consent to participate in English
Exclusion Criteria for participants (receiving the TTIP-PRO intervention):
- demonstrate difficulty understanding the study as assessed with four true-false questions (i.e., 1. This is a research study; 2. Your participation is entirely voluntary; 3. You will be asked questions about your risk of opioid overdose.; 4. Your participation will involve several phone calls).
Inclusion Criteria for Peer Interventionists:
- be 18 years of age or older at time of enrollment
- be enrolled in a methadone-maintenance or buprenorphine- maintenance treatment program for at least one year
- report being opioid-abstinent for at least one year
- meet at least one of the following: has experienced/witnessed/lost a family member or friend to an overdose
- be able to provide informed consent in English
Exclusion criteria for Peer Interventionists:
- have significant treatment/clinical concerns as determined by treatment program staff
The primary pool of potential Peer Interventionists will be patients enrolled in the UC Health (University of Cincinnati Physicians Company) methadone-maintenance or buprenorphine- maintenance treatment programs. Recruitment will be through clinic postings and word of mouth. It is estimated that 2-3 Peer Interventionists will be enrolled in the study.
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
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: TTIP-PRO
Patients who have experienced an OOD in the past 8 months will be eligible to receive TTIP-PRO.
A letter about the study will be sent to those patients.
Interested patients will call the UC Health staff working on this study.
The intervention entails administering the Personal Opioid-Overdose Risk Survey and the Opioid Overdose and Treatment Awareness Survey to the patient.
The TTIP-PRO computer program uses the information to generate the "Personal Feedback Report", which is used by the Peer Interventionist to provide the intervention.
The TTIP-PRO computer program also creates the "Personal Risk Factors Report" which is mailed to the participant with some other helpful information.
|
The peer-delivered TTIP-PRO intervention is designed to: 1).
increase the patient's knowledge of risk factors for OOD, with a particular emphasis on the patient's personal risk factors.
This aim is one of harm reduction and is intended to help patients who continue to abuse opioids to use in a safer manner and 2).For patients who are open to considering treatment, to encourage the patient to get treatment for his/her opioid use disorder.
This goal is based on research findings that effective treatment reduces the risk of OOD.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Study Acceptability (proportion of patients who: a). call about the study and b). agree to participate in the study and c). who complete the study.)
Periodo de tiempo: 6 months
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Acceptability of the study will be assessed based on the proportion of patients who: a). call about the study and b). agree to participate in the study and c). who complete the study. Acceptability of the study will be further assessed by peer interventionists who: a). complete the training and b). complete the study (i.e. continue to successfully provide intervention to assigned participants through the end of the study). |
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Impact of TTIP-PRO on knowledge about Opioid Overdose. (will be assessed with a paired difference test (e.g., paired t-test))
Periodo de tiempo: 6 months
|
The impact of the TTIP-PRO on knowledge about OOD will be assessed with a paired difference test (e.g., paired t-test).
Finally, summary statistics for the proportion of participants willing to be contacted by a MAT staff member after receiving the TTIP-PRO intervention will be calculated.
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6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
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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
1 de septiembre de 2014
Finalización primaria (Actual)
1 de febrero de 2015
Finalización del estudio (Actual)
1 de febrero de 2015
Fechas de registro del estudio
Enviado por primera vez
30 de octubre de 2014
Primero enviado que cumplió con los criterios de control de calidad
3 de noviembre de 2014
Publicado por primera vez (Estimar)
4 de noviembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de mayo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
27 de mayo de 2015
Última verificación
1 de mayo de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2014-2591
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