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 MedAware 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
prescription drug misuse. The secondary outcome measures are: the Pain Medication
Questionnaire (also an indicator of risk of prescription drug misuse), attitudes and
knowledge related to prescription drug 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 for prescription drug misuse will be measured using a 6-item 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 scale includes items such as:
(1) "At times I need to borrow pain medication from friends or family to get relief;" and (2)
"How many times in the past year have you asked your doctor to increase your prescribed
dosage of pain medication in order to get relief?" Additionally, the Current Opioid Misuse
Measure (COMM) (Butler et al., 2007) will be used to measure risk for opioid prescription
drug misuse. It measures 17 misuse behaviors over the past 30 days for those currently taking
medications.

Attitudes. Forty-one attitudinal items will assess prescription drug misuse-related
attitudes. Eight items came from the Prescription Drug Attitudes Questionnaire (PDAQ)
(Bodenlos et al., 2014) and were adapted by the investigators for the military. Five items
measure perceived harm (O'Neill, 2011), which were adapted from the Monitoring the Future
study. There are 26 additional investigator-developed items that specifically align with the
app's main messages. And finally, there are two additional items on perceived behavioral
control indicating decisions to stay away from misusing and from abusing prescription drugs
(O'Neill, 2011).

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

Additional measures include: preparedness to talk about prescription drug misuse; 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.

Inclusion Criteria:

- Age 18 or older (up to 55 years old)

- On active-duty status

- In the Navy or Marine Corps

- Currently prescribed a medication with the potential for misuse

- Owns a smartphone

Exclusion Criteria: