Medsma℞t mobile ed
Mise en œuvre des familles Medsma℞t en milieu de service des urgences: une approche basée sur le jeu pour améliorer la sécurité des opioïdes parmi les adolescents et les parents
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Joseph Strong
- Numéro de téléphone: 859-562-2766
- E-mail: jmstrong@uky.edu
Lieux d'étude
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Illinois
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Rockford, Illinois, États-Unis, 61104
- Swedish American Hospital
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Contact:
- Deanna Berg
- Numéro de téléphone: 779-696-6152
- E-mail: DBerg3@uwhealth.org
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Contact:
- Jessica Scott
- Numéro de téléphone: 779-696-4243
- E-mail: JScott@uwhealth.org
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Wisconsin
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Madison, Wisconsin, États-Unis, 53792
- University Hospital
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Contact:
- Allie Hurst
- Numéro de téléphone: 608-263-3258
- E-mail: ahurst@medicine.wisc.edu
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Chercheur principal:
- Allie Hurst, MD
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Madison, Wisconsin, États-Unis, 53718
- East Madison Hospital
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Contact:
- Melanie Hankes
- Numéro de téléphone: 608-890-9098
- E-mail: MHankes@uwhealth.org
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Contact:
- Kayla Zubke
- Numéro de téléphone: 608-421-7367
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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. |
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Aucune intervention: Control
This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Safe Opioid Storage Behaviour over 9 months
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline, 3, 6, and 9 months.
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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.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Olufunmilola Abraham, PhD, University of Kentucky College of Pharmacy
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 98853
- R18HS030202 (Subvention/contrat AHRQ des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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