Mobile Application for Prescription Drug-Abuse Education (MAPDE)

Subjects:

Eighty active duty participants will be initially recruited for this study. With attrition, the final sample size is expected to be 60. Potential participants will be patients of the pain clinic, deployment health clinic or other clinics, or pharmacy patrons of the Naval Medical Center San Diego (NMCSD) who have currently been prescribed a medication(s) with the potential for misuse. The participants will likely reflect the demographics of the overall Navy population. The sample is also expected to include a variety of racial groups and ranks. A list of prescription medications with the potential for misuse will be used for the medication criterion. The list was developed based on information from the National Institute on Drug Abuse, Commonly Abused Drugs Charts-prescription drugs; the Drug Enforcement Agency; and consultations with Navy pain clinic physicians and a Navy pharmacist.

Methods and Informed Consent Plan:

Study design. The study consists of a randomized controlled design with two groups. The control group will be provided with treatment as usual, and the experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. Repeated measures will be administered to all participants at baseline, 1 month, and 3 months. This study does not propose any modification of, change to or interference with the physician's treatment plan, and the app is not considered a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Study results will also be used to determine estimates of intervention effect sizes to be used in a later effectiveness trial. In addition, the study will determine the feasibility and acceptability of the mobile app.

Recruitment. Participants will be recruited from patient waiting rooms and medical offices of the NMCSD and pharmacy waiting areas using two approaches. The first approach is using flyers about the study opportunity that will be posted in the waiting areas, clinics, and pharmacy. The flyer will instruct potential participants to contact the Principal Investigator (PI) to learn more about the study. The second approach is an in-person approach to tell potential participants about the study opportunity. This will occur by having a research team member onsite in the pharmacy waiting room area handing out flyers and asking potential participants if they would be interested in the study. The research team member can explain more about the study, go over the inclusion criteria, and answer any questions. Similarly, when a clinic staff member or provider sees a clinic patient, he or she will hand them a flyer.