A Prospective Cohort Study of Contingency Management Using A Smartphone Application in Patients With Substance Use Disorder
Conditions: Substance Use Disorders
Sponsor: BrightView LLC

 
 
A Prospective Cohort Study of Continency Management Using a Smartphone App 
Application in Patients with Substance Use Disorder 
 
Document Date: 12-20-2018 
 
 
 
 

Title:  
A Prospective Cohort Study of Continency Management Using a Smartphone App 
Application in Patients with Substance Use Disorder 
 
A. Type of Research 
 
To test the acceptance and efficacy of a smartphone app (DynamiCare RewardsTM) for patients with 
substance use disorder (SUD) who are in active treatment and recovery at BrightView centers. 
Patients will perform self-tracking of their recovery behavior (e.g., counseling attendance, 
abstinence from drugs and alcohol) and the application will support their motivation to maintain 
their desired health behaviors through the implementation of contingency management (CM) 
through the DynamiCare smartphone app. This device poses non-significant risk to participants 
and is exempt from IDE regulations [21 CFR 812.2(c)]. 
 
 
B. Background/Purpose of the Study                                                                                
Opioid dependence (OD) is a chronic relapsing disorder [1]. Like in other chronic conditions, its 
treatment should be open ended and should comprise long-term care strategies and regular 
monitoring; medication should be accessible, with dosing and duration based on scientific 
evidence [2]. Based on a multitude of studies in various settings, medication assisted treatment 
(MAT) has been recognized as the treatment of choice for opioid dependence. The typical 
perspective on treatment retention, one of the pivotal outcomes used for evaluation of MAT, 
contributes to this phenomenon by obscuring the chronic nature of opioid dependence [3-6].  When 
MAT is provided, long-term treatment is restricted by abstinence from substance use as 
precondition to enroll or stay in treatment [7]. Contingency Management (CM) is shown as a highly 
effective, evidence-based methodology for improving substance use disorder (SUD) outcomes. It 
does so by activating the brain’s reward and inhibitory systems through both positive and negative 
reinforcement using immediate, concrete incentives in a progressive reinforcement schedule. CM 
involves setting frequent (>1/week), objective goals (usually abstinence or participation in 
treatment), which patients can achieve to earn tangible rewards (such as cash or vouchers) [8-10]. 
Therefore, an automated version of CM for patient self-tracking (DynamiCare Rewards™) which 
does not require substantial staff effort, could be beneficial to improve patient outcomes. The 
DynamiCare smart phone app (iOS/Android) uses CM to incentivize patients to attend scheduled 
appointments and to submit negative alcohol and drug tests as they are rewarded for these 
behaviors. The DynamiCare smart phone app will be used to see if treatment retention can be 
increased when this app is added to treatment as usual, as well as whether the percentage of 
scheduled appointments can be increased by using the app.  In addition, we want to see if using 
the DynamiCare app can reduce substance use. The intentions of this project are to assess whether 
use of the 
 

 
 
 
 
 
 
 
 
 
 
smartphone app as an add-on to treatment as usual can increase treatment retention, increase the 
percentage of appointments that are kept, and whether substance use can be reduced (Please see 
snapshots). 
In this study, we aim to: 1) promote an overlooked yet effective evidence-based methodology which 
consistently tracks the patients and improves patient medical outcomes; 2) overcome known 
barriers by using an automated solution (the DynamiCare platform; please see snapshots) to benefit 
patients, families, providers, and payers, and 3) validate the system’s acceptability and initial 
efficacy in a pilot study that will inform Phase II efficacy and integration testing. We believe we can 

build a rapidly scalable, sustainable process that 
makes the field of addiction treatment more effective, accountable, and accessible using the 
DynamiCare Rewards™. 
 
 
 
 
 
C. Objectives of the Study                                                                                
The objectives of study are: 
i.    Reduction in drug use – As measured by urine toxicology results. Percentage of patients 
testing consistent only for prescribed substances in random clinical urine tests. 
ii.   Retention –Percent of patients who are still active in the DynamiCare app and/or 
attending treatment sessions after 1, 2, 3, 4 months.  Post-intervention retention at 
BrightView at 6 months will also be measured. 
iii.  Attendance – As measured by % of attendance of medical and clinical appointments. 
 
D. Study Design and Prevention of Risks 
Prospective cohort study- This study will focus on controlled trial of a 4 months-long using 
DynamiCare app to track and reward 100 patients with drug addiction who are enrolled at Brightview 
programs. Comparative outcomes will be measured against 100 patients at a different but similar 

BrightView treatment site. A subject participating in the study may experience potential medical 
benefits, i.e., increased awareness and focus on achieving desired health goals, i.e., maintenance 
of abstinence from drug use. Participants in the pilot study will be enrolled at BrightView outpatient 
SUD programs who are: 1) >18 years old; 2) SUD as the primary substance use problem; 3) have 
and use an Android or iOS smartphone with acceptable capability; 4) are willing to participate in 
home testing and use of the smartphone, 5) speak and read the English language adequately to 
understand smartphone commands and responses and 6) are willing to be randomly assigned to 
receive treatment with or without the smartphone app as an added feature. 
The study design will prevent or minimize potential risks or discomforts to the greatest extent 
possible via having patients use a passcode on their smartphones, use of a random code number 
for patient record identification rather than patient names, data encryption for all electronic 
transmissions, destruction of substance testing video selfies in the immediate timeframe following 
test validation, and use of HIPAA-compliant data storage servers (please see the snapshot). 
After completing the Informed Consent process, a baseline assessment will then be conducted with 
consented participants prior to any other study procedures and participants will provide baseline 
demographic data and information on their recent substance use and severity using the self-
administered Brief Addiction Monitor. In addition, a urine sample will be collected at baseline and 
each study visit as indicated by the ASAM guidelines to be tested for substances in routine clinical 
urine tests. Breathalyzers 
 
 
may be used when indicated for patients with Alcohol Use Disorder or when there is concern for 
problematic alcohol use. Study procedures related to the DynamiCare Rewards intervention are 
conducted via smartphone. 
 
E. Procedures for the Study 
If the patient is interested, information about study procedures and requirements will be provided 
for review as well as a video describing the DynamiCare Rewards program.  If the patient remains 
interested and If eligibility criteria are met, research member will meet with the patient, review the 
eligibility criteria, answer any questions about the study, and obtain written Informed Consent. A 
baseline assessment will then be conducted with consented participants prior to any other study 
procedures. 
After completing the Informed Consent process, participants will provide baseline demographic 
data and information on their recent substance use and severity. In addition, a urine sample will be 

collected at baseline and each study visit as 
indicated by the ASAM guidelines. Breathalyzers 
may be used when indicated for patients with 
Alcohol Use Disorder or when there is concern for 
problematic alcohol use. 
Study procedures related to the DynamiCare 
Rewards 
intervention 
are 
conducted 
via 
smartphone and there are no visits related to the 
study intervention. Research visits including 
collection of a urine sample and medical exams. 
Participants 
assigned 
to 
the 
DynamiCare 
Rewards group will receive: 1) the app on their 
smartphone, 2) drug testing devices when 
indicated (pocket-sized breathalyzer), and a reloadable debit card for receiving the financial 
incentives (the PEX debit card). The app will periodically prompt the user to deliver a urine drug test 
or conduct a breathalyzer. The breathalyzers (BACTrack Mobile Pro) submit BAC results directly to 
the smartphone app via Bluetooth. When taking these tests, patients take selfie videos of 
themselves and these videos are loaded to DynamiCare’s Analytic website where they are viewed 
by trained personnel to ensure that they are valid.  Videos are kept for 7 days and then destroyed.  
GPS tracking also ensures that patients have attended their scheduled appointments.  GPS is not 
used at any other times.  All information is uploaded on the DynamiCare Analytic website where 
providers can see the status of patients.  Information includes whether appointments have been 
attended, the status of all alcohol and drug testing, and incentives earned. (please see snapshots). 
 
 
 

Negative tests result in points which the patient can immediately transfer from a reserve account 
(where the patient’s incentive funds are inaccessible), to the spendable PEX debit card. The amount 
of funds are available on a progressive variable reward schedule. The app provides reminders to 
patients for all therapy and drug/alcohol testing appointments.  It also informs providers if 
appointments have been kept, and whether breathalyzer and oral saliva testing has been completed 
as well as the results of these rests.  Both providers and patients can schedule appointments.  
Patients do this via the app; providers via the DynamiCare Analytic website. 
The PEX card provides a convenient way to monitor and protect the patient from risky spending. 
The card will block cash withdrawals, and spending at identified liquor stores and bars. All 
substance testing devices and the debit card are existing, commercially available, valid and reliable 
products. At all times, the participant retains the right to choose whether to use, and when to use 
the devices and funds. 
 
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