Medsma℞t Mobile Ed
Implementación de familias Medsma℞t en el entorno del departamento de emergencias: un enfoque basado en el juego para mejorar la seguridad de los opioides entre adolescentes y padres
The goal of this clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. The main question it aims to answer is:
• Can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional opioid-related counseling alone?
Participants will, in addition to receiving opioid counseling:
- Join an online meeting with research staff to test the smartphone-based intervention
- Report demographic information
- Complete surveys about opioids
- Complete a family medication safety plan
- Complete surveys after 3, 6, and 9 months
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Joseph Strong
- Número de teléfono: 859-562-2766
- Correo electrónico: jmstrong@uky.edu
Ubicaciones de estudio
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Illinois
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Rockford, Illinois, Estados Unidos, 61104
- Swedish American Hospital
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Contacto:
- Deanna Berg
- Número de teléfono: 779-696-6152
- Correo electrónico: DBerg3@uwhealth.org
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Contacto:
- Jessica Scott
- Número de teléfono: 779-696-4243
- Correo electrónico: JScott@uwhealth.org
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University Hospital
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Contacto:
- Allie Hurst
- Número de teléfono: 608-263-3258
- Correo electrónico: ahurst@medicine.wisc.edu
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Investigador principal:
- Allie Hurst, MD
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Madison, Wisconsin, Estados Unidos, 53718
- East Madison Hospital
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Contacto:
- Melanie Hankes
- Número de teléfono: 608-890-9098
- Correo electrónico: MHankes@uwhealth.org
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Contacto:
- Kayla Zubke
- Número de teléfono: 608-421-7367
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults who receive an opioid prescription from a study Emergency Department, AND
- who report having an adolescent, aged 12-18, living at home, AND
- who speak and understand English
- Each participant must have the ability to provide informed consent
Exclusion Criteria:
- Adults who do not receive an opioid prescription from a study Emergency Department AND/OR
- who do not have an adolescent, aged 12-18, living at home, AND/OR
- who do not speak or understand English
- Adults and/or adolescents who do not have the ability to provide informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention
This group will receive the intervention of interest, MedSMA℞T Mobile, in addition to standard opioid-related counseling. MedSMA℞T Mobile is a serious game (intended to educate while entertaining) focused on opioid safety. |
MedSMA℞T Mobile is an innovative mobile digital health intervention that integrates technology-based learning to facilitate family communication and creation of a personalized Family Medication Safety Plan. The Family Medication Safety Plan (FMSP) is a tool for families to record important information about their medications and create a plan for safe use, storage, and disposal. Participants will play MedSMA℞T Mobile for up to 30 minutes at the first study visit. |
|
Sin intervención: Control
This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study
Periodo de tiempo: Baseline, 3, 6, and 9 months.
|
The fourth factor of the Adolescent Opioid Safety and Learning (AOSL) scale, Opioid Harm, measures understanding of negative social and professional effects of opioid misuse. Scores range from 3-15, where 3 indicates the lowest level of overall opioid harm awareness and 15 is the highest level. |
Baseline, 3, 6, and 9 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Safe Opioid Storage Behaviour over 9 months
Periodo de tiempo: Baseline, 3, 6, and 9 months.
|
This outcome contains 4 items from the Wisconsin Strategic Prevention Framework Partnerships for Success Community Survey - V02, comprised of yes/no questions. The minimum score for this scale is 0 (indicating least safe opioid storage behaviour) and the maximum is 4 (indicating most safe opioid storage behaviour). |
Baseline, 3, 6, and 9 months.
|
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Change in Opioid Disposal Behaviour over 9 months
Periodo de tiempo: Baseline, 3, 6, and 9 months.
|
This outcome contains 6 items from the Wisconsin Strategic Prevention Framework Partnerships for Success Community Survey - V02, and includes yes/no questions. The minimum score for this scale is 0 (indicating least safe opioid disposal behaviour) and the maximum is 6 (indicating most safe opioid disposal behaviour). |
Baseline, 3, 6, and 9 months.
|
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Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months
Periodo de tiempo: Baseline, 3, 6, and 9 months.
|
This section covers the second factor, Learning About Medication, of the Medication Understanding and Use Self-Efficacy (MUSE) scale. This factor is comprised of 4 items, each scored 1-4. The minimum score is 4, and the maximum is 16. A score of 4 indicates lower understanding and self-efficacy in opioid use, whereas a score of 16 indicates highest level of understanding and self-efficacy in opioid use. |
Baseline, 3, 6, and 9 months.
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Change in Family Communication Behaviour Patterns over 9 months
Periodo de tiempo: Baseline, 3, 6, and 9 months.
|
This includes both the parent and child versions of the 26-item, 2-factor scales. The first factor, Conversation orientation, contains 15 items. The second factor, Conformity orientation, contains 11 items. Items are scored from 1-5, where 1 is "Disagree Strongly" and 5 is "Agree Strongly". Scale scores are averages for the two scales, with each item contributing equally. The minimum and maximum average scores, therefore, cannot exceed 1 and 5, respectively. |
Baseline, 3, 6, and 9 months.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Olufunmilola Abraham, PhD, University of Kentucky College of Pharmacy
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- 98853
- R18HS030202 (Subvención/Contrato de la AHRQ de EE. UU.)
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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