MEDSMA℞T MOBIL ED
Implementering av MEDSMA℞T-familjer i akutmottagningen: En spelbaserad strategi för att förbättra opioidsäkerheten bland ungdomar och föräldrar
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Joseph Strong
- Telefonnummer: 859-562-2766
- E-post: jmstrong@uky.edu
Studieorter
-
-
Illinois
-
Rockford, Illinois, Förenta staterna, 61104
- Swedish American Hospital
-
Kontakt:
- Deanna Berg
- Telefonnummer: 779-696-6152
- E-post: DBerg3@uwhealth.org
-
Kontakt:
- Jessica Scott
- Telefonnummer: 779-696-4243
- E-post: JScott@uwhealth.org
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53792
- University Hospital
-
Kontakt:
- Allie Hurst
- Telefonnummer: 608-263-3258
- E-post: ahurst@medicine.wisc.edu
-
Huvudutredare:
- Allie Hurst, MD
-
Madison, Wisconsin, Förenta staterna, 53718
- East Madison Hospital
-
Kontakt:
- Melanie Hankes
- Telefonnummer: 608-890-9098
- E-post: MHankes@uwhealth.org
-
Kontakt:
- Kayla Zubke
- Telefonnummer: 608-421-7367
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Inget ingripande: Control
This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Safe Opioid Storage Behaviour over 9 months
Tidsram: 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.
|
|
Change in Opioid Disposal Behaviour over 9 months
Tidsram: 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.
|
|
Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months
Tidsram: 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.
|
|
Change in Family Communication Behaviour Patterns over 9 months
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Olufunmilola Abraham, PhD, University of Kentucky College of Pharmacy
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 98853
- R18HS030202 (U.S.A. AHRQ-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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