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.

When the potential participant contacts the PI about the study, the PI will verbally confirm if the participant meets the inclusion criteria. The PI will also emphasize that participation is voluntary. If they meet the criteria, the PI will then ask for their non-Department of Defense (DoD) email address to communicate with the participant during the study, and to link their surveys over time. Non-DoD email addresses are less likely to contain a person's full name compared to DoD email addresses. However, in the case that the potential participant is uncomfortable using their current non-DoD (personal) email address, the investigators will provide instructions for setting up a new personal email account on Gmail if they would like to create a new email address for the study to further ensure their anonymity. The PI will send an email to the participant with the: (1) consent form in an attachment for their review; (2) a web link to access the survey website; and (3) instructions for creating a new personal email address for the study with a request to send that to the PI.

The PI or study staff will randomly assign the participant to a study condition, which will indicate which survey link or path, specific to the study condition that they will receive, and then the participant will be sent an email. Each email path will have identical consent documentation; however, this method enables the study team to tailor the follow up messaging more easily. The PI will maintain a list of participant emails and their study group assignment for the purpose of sending survey and intervention reminders.

Informed consent plan. The participant will have received a copy of the consent form in the email from the PI. Also, once the participant accesses the web link (for either survey path-intervention group or control group), the first page they will see will be the consent page. If the participant has any questions, the form encourages the participant to contact the PI and ask questions about the research. If the participant consents to participate, they will indicate this on the web-based consent form by clicking the appropriate box ("I consent" or "I do NOT consent"). If "I do NOT consent" is selected, a screen that thanks them for visiting the site will appear along with the standard instruction to close their browser. The participant must also check a box indicating that they attest that their participation is during off-duty, liberty or leave status to continue to the survey.

Procedures. After the subject consents to participate, the website will also present them with a statement that requires the participant to agree, by checking a box, that their participation will only take place during their off-duty time. (The consent form also clearly instructs participants to complete the survey during their off-duty time.)

The surveys will be web-based and the website will be hosted on a Qualtrics server that uses a high-end firewall system, transport layer security, passwords, and encryption.

Participants will be asked to enter their non-DoD email address as a way to link their surveys over time. Then, they will enter their responses online; their data will automatically be saved to a data file. Measures will be taken to protect the email addresses and survey data collected. After submitting the baseline survey, participants in the intervention group will get instructions for downloading the app. They will be asked to download the app from the app store (e.g., iOS or Google app store), and they will be given a unique key number to access the app once downloaded. The user will also be required to set up a separate self-selected 4-digit PIN and re-enter it each time they open the app, to further enhance security. Neither the participant's phone number nor any identification that can be used to identify the phone or its user will ever be stored in the app developer's server.

While the intervention participants will see the above described download instructions prior to this step, control group participants will be directed to the gift code page immediately after completing their baseline survey. At this gift code page all participants will be presented with instructions on how to get their electronic gift code as a thank-you for their time.

The baseline survey and the 2 follow-up surveys will take about 40 minutes each to complete. The subject will be notified via email about when to complete the baseline, 1-month, and 3-month surveys. There will be an initial request to complete each survey, followed by 2 reminders.

Measures. The data collected for this study will be self-reported survey data collected at baseline, 1 month and 3 months after baseline.

The main outcome measure is the Current Opioid Misuse Measure as an indicator of the risk of opioid misuse. The secondary outcome measures are: the Pain Medication Questionnaire (also an indicator of risk of prescription drug misuse), prescription drug attitudes, knowledge related to prescription drug misuse and preparedness to talk about misuse. All outcomes will be measured as the change from baseline to the follow-up surveys (at 1 and 3 months). These are listed in the Outcomes Measures section of this record; however, additional scale information is described here:

Risk of opioid misuse. The Current Opioid Misuse Measure (COMM) (Butler et al., 2007) was used to measure risk for opioid prescription drug misuse. It measures 17 misuse behaviors over the past 30 days for those currently taking medications.

Risk of misuse. Risk for prescription drug misuse was measured using a 5-item scale that was adapted from a brief scale previously used by Morasco and Dobscha (2008), which is actually a subset of the Pain Medication Questionnaire (PMQ) scale (Adams et al., 2004). The original scale was created to screen for prescription drug misuse among chronic pain patients undergoing opioid therapy, and the shortened scale was created for use among a military veteran population. The present scale includes items such as, "I get pain medication from more than one doctor in order to have enough medication for my pain" and "at times I need to take medication more often than it is prescribed in order to relieve my pain."

Attitudes. Attitudes were assessed in 2 ways. First, the 8-item Prescription Drug Attitudes Questionnaire (PDAQ) (Bodenlos et al., 2014) was adapted by the investigators for the military for this study. Second, the investigators developed 22 prescription drug misuse-related attitude items that specifically aligned with the app's main messages.

Knowledge. Twenty-three multiple choice knowledge items will assess the participant's level of knowledge of the definition of misuse and related educational points.

Preparedness to talk about misuse. Two investigator-developed items were used to assess the level of preparedness to talk to others (i.e., chain of command, doctor) about concerns related to one's own possible prescription drug misuse, In addition, two other investigator-developed items were used to assess the level of preparedness to talk to others about their (e.g., fellow service member, spouse) possible misuse.

Additional measures include: medication use and pain; mental well-being (using the PC-PTSD (Prins et al., 2003) based on the PTSD Checklist (Weathers, Litz, Herman, Huska, \& Keane, 1993); PHQ-4 (Kroenke, Spitzer, Williams, \& Lowe, 2009); and the Defense and Veterans Brain Injury Center TBI screening tool (Schwab, Baker, Ivins, et al., 2006)); and participant's demographics.

In addition, experimental group participants only will receive 21 items about their experience with the app in the 1-month and 3-month surveys. These items will assess time spent using the app, ease of use, overall satisfaction with the app, usefulness of particular sections, relevance of the content, etc. Also, aggregated data on app page views and navigation patterns will be assessed. This aggregated usage information is collected securely and anonymously for research purposes.

Statistical analysis plan:

Results will be analyzed using a 2 x 3 (group: experimental/control, by time: baseline/1-month/3-month), repeated measures analyses of variance (ANOVA) to examine the potential effectiveness of the program over the 3-month study period. Categorical outcomes will be analyzed using generalized linear mixed models for binary outcomes. Group by time interactions will be examined for any evidence of improvement where greater positive changes in risk for misuse and related outcomes for the experimental group compared to the control group are observed. In addition, descriptive statistics will be used to assess the sample and to examine experimental group participants' satisfaction with and use of the app. Attrition analyses using independent t-tests and Chi-square tests will be carried out among the total sample, as well as by group to examine differences in participant characteristics among attriters and non-attriters. An alpha level of 5% will be assumed in all statistical tests. All analyses will be conducted using IBM SPSS Statistics 19.0.