Opioid Use
Conditions
Brief summary
A key driver of the current opioid overdose epidemic is the misuse of legitimately prescribed opioid medications. Patient education through use of mobile technology may help to increase knowledge of appropriate use of opioid medications; however, knowledge does not always translate into behavior modification. Therefore, there is a need for more research into patient-facing technology that can increase both knowledge and behaviors consistent with appropriate opioid use. These needs have been amplified by the severe acute respiratory syndrome coronavirus-2 (COVID-19) pandemic, which has exposed healthcare disparities, heightened the risk for mental and behavioral health disorders, and dramatically increased reliance on telehealth technologies. It is critically important that telehealth solutions be accessible and user-friendly for all consumers, particularly members of underserved communities with limited digital health literacy. This feasibility study will develop a mobile health app to improve appropriate use of opioid medications among patients with a prescription to treat non-cancer pain. The study will use focus groups with consumers and providers to determine the content and features to be included in the app and will test the feasibility of implementing a contingency management approach (i.e., rewards system) with the app using a randomized control trial. The key outcome of interest is confirmation of the design and operating specifications of the app, including the use of contingency management. Secondary outcomes of interest are the overall rating of the app and an increase in knowledge among users regarding the safe use, storage, and disposal of opioid medications.
Interventions
DEVICEPrescription Opioid Management App
Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants will enter all data using a numeric identifier assigned by a third-party recruiter
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Has current prescription for opioid medication * Any ethnic group * Served through the following programs of partnering organization: primary medical care, transgender medical care, HIV and sexually transmitted infection (STI) screening and counseling, LGBTQ services, pre-exposure prophylaxis and post exposure prophylaxis services, health education, clinical research, case management, psychosocial services, nutrition counseling, treatment adherence * Owns an Android-base smartphone
Exclusion criteria
* Unable to provide informed consent * Pregnant women * Currently being treated for/history of mental health or substance use disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device functionality | Assessed at the end of the one-week trial | Confirmation that the app features work as intended based on user input |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobile App Rating Scale (MARS) | Data collected through app and telephone interviews at the end of the one-week trial | Participants' assessment of functionality and utility of app with 19 items scored from 1 to 5 (overall score range 19 to 95) where higher scores indicate better app rating |
| Change in knowledge quiz score | Change in score as assessed at the end of the one-week trial | Participants will show an increase in knowledge related to the safe used, storage, and disposal of opioid medications based on a 10-item, investigator created, pre/post quiz (total score range of 1 to 10) designed to address key educational components of the app |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnn D Bagchi, PhD,DNP
Rutgers, The State University of New Jersey
Outcome results
None listed