Implementing MedSMA℞T Families in the Emergency Department Setting: A Game-based Approach for Improving Opioid Safety Among Adolescents and Parents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 244
- Locations
- 3
- Primary Endpoint
- Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department.
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.
Intervention: MedSMA℞T Mobile (Behavioral)
Outcomes
Primary Outcomes
Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study
Time Frame: 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.
Secondary Outcomes
- Change in Safe Opioid Storage Behaviour over 9 months(Baseline, 3, 6, and 9 months.)
- Change in Opioid Disposal Behaviour over 9 months(Baseline, 3, 6, and 9 months.)
- Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months(Baseline, 3, 6, and 9 months.)
- Change in Family Communication Behaviour Patterns over 9 months(Baseline, 3, 6, and 9 months.)
Investigators
Olufunmilola Abraham
Professor
University of Kentucky