Pilot Trial Leveraging Smartphone-paired Breathalyzers and Loss- and Gain-framed Text Notifications for Reducing Drinking Driving
Phase: NA
Conditions: Alcohol Drinking, Alcohol Intoxication, Alcohol Impairment, Drive, Driving Impaired, Driving Under the Influence, Behavior, Drinking
Sponsor: University of Pennsylvania

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Basic Info 
Protocol Number: 827345 
Principal Investigator: DELGADO, MUCIO C 
Protocol Title: Pilot trial leveraging smartphone-paired breathalyzers and loss- and gain-framed 
text notifications for reducing drinking driving 
Short Title: BE SAFE 
Protocol Description: This project aims to demonstrate the feasibility of a scalable behavioral 
intervention using smartphone-paired breathalyzers and text messages aimed at reducing drinking and 
driving among individuals who report heavy drinking. Participants receive a smartphone breathalyzer to 
provide feedback on their estimated blood alcohol level. The intervention compares loss- and gain-
framed messages that make the consequences of drinking and driving more salient to standard 
messages not to drink and drive. 
Submission Type: Social and Biological Sciences 
Application Type: FULL 
 
Study Instruments 
Discuss the particulars of the research instruments, questionnaires and other evaluation instruments in 
detail. Provide validation documentation and or procedures to be used to validate instruments. For well 
know and generally accepted test instruments the detail here can be brief. More detail may be required 
for a novel or new instrument. For ethnographic studies identify any study instruments to be used (i.e. 
for deception studies) and describe in detail where, when and how the study will be conducted and who 
or what are the subjects of study. Note: For more information on how to conduct ethical and valid 
ethnographic research, follow the link For oral histories or interviews provide the general framework for 
questioning and means of data collection. If interviews or groups settings are to be audio taped or video 
taped describe in detail the conditions under which it will take place. Include a copy of any novel or new 
test instruments with the IRB submission. 
 
1. Intake Survey (attached to the protocol) a) Driving History and Experience Questionnaire DHEQ 
(Harrison & Fillmore, 2005): This self-report questionnaire gathers information on driving history and 
behaviors. Included in the questionnaire are measures of driving experience such as length of time 
holding a driver’s license and number of days and miles driven per week. The questionnaire also gathers 
information about participants driving behaviors, such as license revocations, presence and number of 
DUI citations and punishments, traffic accidents, traffic tickets, typical driving environment (rural, urban, 
and interstate), and the type of vehicle transmission (manual, automatic, or both). b) Drinking and 
driving questionnaire (McCarthy et al): This self-report questionnaire gathered information on 
individuals drinking and driving history. The questionnaire asked participants to respond to questions 
about drinking and driving history on 4 or 5 point Likert scales. The questionnaire included a measure of 
frequency of drinking and driving and typical quantity of alcohol consumed before driving. The items 
were obtained from a scale reported by McCarthy et al. (2012). c) Delayed discounting questionnaire 
(Senecal, Kable et al 2012). Time discounting (known interchangeably as present-biased preferences or 
delay discounting) is a measure of impulsivity that reflects people’s tendencies to discount the value of a 

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reward as a function of how far in the future it would be received. It has been established that people 
who engage in maladaptive behavior such as drinking and using other drugs have steeper delayed 
discounting functions, meaning they have stronger present biased preferences. 
This is expected because engagement in unhealthy behaviors entails immediate gratifications in 
exchange for future health problems. It is not known whether a similar pattern of behavior is present in 
those engaging in drinking and driving. Consistent with prior work, we will use the 51-item monetary 
choice questionnaire developed by Seneca; and colleagues (2012) that defines 10 ranges of delayed 
discounting by fitting a hyperbolic function to participants expressed preferences for smaller immediate 
versus larger delayed rewards. d) Barratt Impulsiveness Scale BIS-11 (Patton et al., 1995) This 30-item 
self- report questionnaire is designed to measure the personality dimension of impulsivity. Participants 
rated 30 different statements on a 4-point Likert-type scale ranging from Rarely/Never to Almost 
Always/Always. Higher total scores indicate higher levels of self-reported impulsiveness. e) Self reported 
drinking. We will collect self-reported drinking days and drinks per day using a timeline follow-back 
method. This method has been used by multiple researchers in the Substance abuse literature since its 
development by Sobell and colleagues (1996). We will cover the previous month in this assessment. f) 
Basic demographics such a race, age, and education. g) Self-report of drinking and driving instances 
(Sloan et al. 2014). This survey is a validated instrument that asks participants to report on their general 
drinking behavior and its relation to driving. 
 
 2. End of Baseline survey (attached to protocol) a) Driving History and Experience Questionnaire DHEQ 
(Harrison & Fillmore, 2005): This self-report questionnaire gathers information on driving history and 
behaviors. This will be modified to cover the length of time since this was previously asked (4 weeks), all 
questions that were used in the intake and are no longer relevant will be removed. b) Drinking and 
driving questionnaire (McCarthy et al): This self-report questionnaire gathered information on 
individuals drinking and driving history. The questionnaire asked participants to respond to questions 
about drinking and driving history on 4 or 5 point Likert scales. The questionnaire included a measure of 
frequency of drinking and driving and typical quantity of alcohol consumed before driving. The items 
were obtained from a scale reported by McCarthy et al. (2012). This survey will be modified to cover the 
previous 4 weeks of the baseline period. c) Self-reported drinking. We will collect self-reported drinking 
days and drinks per day using a timeline follow-back method. This method has been used by multiple 
researchers in the Substance abuse literature since its development by Sobell and colleagues (1996). We 
will cover the previous month in this assessment.  
 
3. End of Study Survey (attached to protocol) a) Driving History and Experience Questionnaire DHEQ 
(Harrison & Fillmore, 2005): This self-report questionnaire gathers information on driving history and 
behaviors. This will be modified to cover the length of time since this was previously asked (4 weeks), all 
questions that were used in the intake and are no longer relevant will be removed. b) Drinking and 
driving questionnaire (McCarthy et al): This self-report questionnaire gathered information on 
individuals drinking and driving history. The questionnaire asked participants to respond to questions 
about drinking and driving history on 4 or 5 point Likert scales. The questionnaire included a measure of 
frequency of drinking and driving and typical quantity of alcohol consumed before driving. The items 
were obtained from a scale reported by McCarthy et al. (2012). 
This survey will be modified to cover the previous 4 weeks of the intervention period. c) Self-
reported drinking. We will collect self-reported drinking days and drinks per day using a timeline follow-
back method. This method has been used by multiple researchers in the Substance abuse literature 
since its development by Sobell and colleagues (1996). We will cover the previous month in this 
assessment.  
 

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4. End of study interview (attached to protocol) This interview will ask about the experience in the trial 
and help determine if this intervention is acceptable and liked by the participants. We will also use this 
interview to inquire about ways it can improve and things that were not liked by each participant.  
 
5. Smartphone Breathalyzer (BacTrack Mobile Pro) This device was chosen as one of the most popular 
currently commercially available breathalyzers that pair with smartphones, which has received growing 
attention in the national media. (A smartphone breathalyzer, 2015; Jolly, 2015). In a recently completed 
study conducted by our team, this was the most accurate smartphone paired breathalyzer available on 
the market and it was actually better than a current police grade breathalyzer at predicting blood 
alcohol levels.  
This study was accepted for presentation at the 2017 Society for the Advancement of Violence 
and Injury Research annual meeting. The device pairs with the BACtrack app available for Android and 
iPhone, which enables the export of data to the study team. The currently collected data fields available 
in this free, publically available consumer application include: guessed BAC, actual BAC, was it 
themselves or friend, GPS coordinates of where BAC was taken, and timestamp of the BAC.  
 
6. TrueMotion Driving app: TrueMotion.is a leading provider of smartphone applications aimed at 
measuring and improving driving behavior. They are the vendor for Progressive Insurances usage-based 
insurance application. The app uses native phone sensors to detect driving and passenger vs. driver 
status. The app is also able to log passenger episodes in which user is using Uber or Lyft. The 
TrueMotion app will be installed on participants’ phones to track driving exposure. Once installed it will 
run continuously in the background without any user interaction. TrueMotion collects the following 
information for each trip level data set (each will be coded with user ID and trip ID): , 1. Start/stop time, 
location, and intensity of detected braking and acceleration events 2. Start/stop time, location, and 
intensity of speeding events (excess speed relative to an absolute threshold or relative to local speed 
limits) 3. OS-level events like screen on, screen unlock, call state 4. Start/stop time and location of 
detected distraction events using our sensor-based algorithms: phone calls (with a detection of in-hand 
versus hands-free) and general non-call usage like tapping, typing. As far as the time-series sensor data 
which can be linked with a user ID and trip ID, TrueMotion will provide: 1. GPS points (lat/lon position, 
speed, accuracy, etc) at 1 Hz IMU sensor data (3-axis accelerometer, gyroscope, and magnetometer) at 9 
Hz. The standard data fields collected and that will be exported include trip start/ stop time, location, 
and mileage The data will be securely transferred to the University of Pennsylvania on a weekly basis.  
 
References 
A smartphone breathalyzer. (2015). Retrieved January 4, 2016, from 
http://www.usatoday.com/videos/tech/2013/05/19/2216497/ BACtrack Mobile Pro. (n.d.). Retrieved 
December 24, 2015, from https://www.bactrack.com/products/bactrack-mobile-
smartphonebreathalyzer 
TrueMotion. https://gotruemotion.com/ Jolly, J. (New Y. T. (2015, December 21). Turning 
Your Smartphone into a Breathalyzer. New York Times. Retrieved from http:// 
well.blogs.nytimes.com/2015/12/21/turning-your-smartphone-into-a-breathalyzer/?smid=fbnytimes& 
smtyp=cur&_r=1 Harrison ELR, Marczinski CA, Fillmore MT. Driver training conditions 
affect sensitivity to the impairing effects of alcohol on a simulated driving test to the impairing effects 
of alcohol on a simulated driving test. Exp Clin Psychopharmacol. 2007;15(6):588-598. doi:http:// 
dx.doi.org/10.1037/1064-1297.15.6.588. Harrison ELR, Fillmore MT. Are bad drivers more impaired 
by alcohol? Sober driving precision predicts impairment from alcohol in a simulated driving task. Accid 
Anal Prev. 2005;37(5):882-889. doi:10.1016/j.aap.2005.04.005. Test A. Intoxilyzer 9000. http:// 
www.alcoholtest.com/intoxilyzer-9000/. Accessed December 24, 2015. Marczinski, Cecile A; Stamates 

V4; 10.4.17 
A. Artificial sweeteners versus regular mixers increase breath alcohol concentrations in male and female 
social drinkers. Alcohol Clin Exp Res. 2013;37(4):696-702. McCarthy DM, Niculete ME, Treloar HR, 
Morris DH, Bartholow BD. Acute alcohol effects on impulsivity: associations with drinking and driving 
behavior. Addiction. 2012;107(12):2109-2114. doi:10.1111/j.1360-0443.2012.03974.x. Patton JH, 
Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995;51 
(6):768-774. Senecal N, Wang T, Thompson E, Kable JW. Normative arguments from experts and peers 
reduce delay discounting. Judgm Decis Mak. 2012;7(5):568-589. Sloan FA, Eldred LE, Xu Y. The 
Behavioral Economics of Drunk Driving. Journal of Health Economics. Duke University. 2014. Vol 35, 
pp 64-81. Sobell LC, Sobell MB, Buchan G, Cleland PA, Fedoroff I, Leo GI (1996). The reliability of 
the Timeline Followback method applied to drug, cigarette, and cannabis use. Paper presented at the 
30th Annual Meeting of the Association for Advancement of Behavior Therapy, New York, NY, 
November 1996. 
Group Modifications 
Describe necessary changes that will or have been made to the study instruments for different groups. 
 
During all phases study staff will collect data from 3 sources: 
 
1) The BACtrack device and app will require the participant to initiate use during all phases of the trial. 
Researchers will instruct participants to use this device during the study when drinking to help inform 
them of their level of impairment and ability to operate a vehicle. See section attached screenshots for 
more information on this app and what it tells users. As part of the BACtrack app each participant will be 
asked to guess what their BAC is prior to submitting a sample. Once a sample is submitted and 
processed the app will display both the actual BAC measure as well as the participants guess. They will 
also be able to indicate of the sample was provided by them or someone else. Data collected using this 
app and device includes guessed BAC, actual BAC, person submitting the sample, GPS coordinates, and 
timestamps.  
 
2) The TrueMotion app will collect participant driving data without any additional initiation by the 
participant. Data collected from this app will include GPS coordinates, driving speed, trip length, time of 
drive, and cellphone use while driving. During a drive or after its completion participants will be able to 
indicate if they are a passenger or a driver.  
 
3) Self-report in the form of a TLFB and additional questions about drinking and driving over the past 7 
days will be collected once a week for all participants. Each week participants will be asked to complete 
a brief survey on the Way to Health site that asks them about drinking events, drinking and driving 
events, and BACtrack use for the previous week. At enrollment, the research coordinator will confirm 
that the participant has an active Uber and/or Lyft app installed and active account. This will be done to 
encourage participants to not drink and drive.  
 
Baseline Phase: All participants will receive an identical baseline phase lasting 4 weeks. This phase will 
serve as a way of capturing observed and self-reported incidents of alcohol use and driving episodes 
after drinking. During this phase participants will be asked to install and use the TrueMotion app and will 
receive a BACtrack device. Once both apps are installed and working the baseline phase will begin.  
 
After the baseline phase, participants will be randomized into one of three arms for the remaining 4 
weeks of the trial:  
 

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1. 
Control arm: Participants assigned to this arm will continue to use the TrueMotion app and 
BACtrack device as in the baseline phase. They will also be asked to complete the same weekly 
self-report survey each week.  
2. 
Loss-framed messaging arm: Participants assigned to this arm will continue to use the 
TrueMotion app and BACtrack device as in the baseline phase. They will also be asked to 
complete the same weekly self-report survey. During this phase participants will receive a text 
message on Thursday, Friday, and Saturday before 6:00 PM that are framed as a loss (financially 
or personal). On each of these days, a text message will be selected from a bank of  messages 
(attached) that utilizes loss aversion as it reminds participants to use the BACtrack app and to 
not drink and drive (for example, “A BAC >0.04 significantly impairs driving and can lead to a 
failed sobriety test. A DUI can land you in jail with $10,000-15,000 in fines and increased 
insurance costs.  Don’t ruin your life: plan a ride and commit to not drinking and driving tonight.  
#BESAFE”). 
3. 
Gain-framed messaging arm: Participants assigned to this arm will continue to use the 
TrueMotion app and BACtrack device as in the baseline phase. They will also be asked to 
complete the same weekly self-report survey. During this phase participants will receive a text 
message (Thursday, Friday, and Saturday before 6:00 PM) that are framed as a gain (financially 
or personal). On each of these days, a message will be selected from a bank of messages 
(attached) that utilizes a gain as it reminds participants to use the BACtrack app and to not drink 
and drive (for example, “A BAC >0.04 significantly impairs driving and can lead to a failed 
sobriety test.  Save a life: plan a ride and commit to not drinking and driving tonight.  #BESAFE”).  
 
Method for Assigning Subjects to Groups 
Describe how subjects will be randomized to groups. 
We will use block randomization where participants and will be to assigned their study arms 
 
Administration of Surveys and/or Process 
Describe the approximate time and frequency for administering surveys and/or evaluations. For surveys, 
questionnaires and evaluations presented to groups and in settings such as high schools, focus group 
sessions or community treatment centers explain how the process will be administered and who will 
oversee the process. For instance, discuss the potential issues of having teachers and other school 
personnel administer instruments to minors who are students especially if the content is sensitive in 
nature. Describe the procedure for audio and videotaping individual interviews and/or focus groups and 
the storage of the tapes. For instance, if audio tape recording is to be used in a classroom setting, 
describe how this will be managed if individuals in the class are not participating in the study. Explain if 
the research involves the review of records (including public databases or registries) with identifiable 
private information. If so, describe the type of information gathered from the records and if identifiers 
will be collected and retained with the data after it is retrieved. Describe the kinds of identifiers to be 
obtained, (i.e. names, social security numbers) and how long the identifiers will be retained and 
justification for use. 
We are planning to recruit and enroll approximately 60 individuals through recruitment material that 
will be sent out through emails and fliers (see recruitment material attached). Participants will also be 
recruited through posted flyers, postcards, email blasts, social media, and by word-of-mouth/colleague 
referrals at Penn. The flyers will be posted in a variety of public and private locations. Research 
assistants will recruit participants by handing out information in crowded places, such as on the street or 
near bars. No one will be approached to participant who appears intoxicated. And No recruitment will 
occur at public or private places without first obtaining permission. The Penn Social Media & Health 

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Innovation Lab will assist with recruitment through a variety of social media outlets including 
Facebook and Craigslist. Language for these postings have been included with the application. All 
recruitment materials will direct potential participants to either visit the Way to Health portal for more 
information and to sign up or to call research staff for more information.  
 
When a participant is ready to register for this study they will be directed to the Way to Health platform. 
A participant will create an account and review an Eligibility screening consent. This brief consent will 
grant us access to administer a brief eligibility survey. We have decided to use this process to reduce the 
time needed to read the full consent for those who may not qualify. Once eligibility has been 
determined eligible participants will be instructed to review and sign the full consent for participation.  
 
We are also planning to recruit through the Emergency Department (ED). Through ED recruitment, we 
will have an opportunity to encounter potential participants who may benefit from this injury 
prevention intervention. The Emergency Departments at the Hospital at the University of Pennsylvania 
(HUP) and Penn Presbyterian Medical Center (PPMC) are staffed with Academic Associates (AA). The AAs 
are a cadre of staff who are trained, provided appropriate access to patient information, and employed 
for the express purpose of screening patients for eligibility upon admission and recruiting patients as 
research participants at clinically appropriate times. The recruitment of research subjects is an ongoing 
procedure in the ED of HUP and PPMC and their systems for subject recruitment are well established. 
The AAs at all locations participate in training seminars throughout the year to stay current with 
protocol updates and to orient to upcoming studies. Approximately 2-4 weeks prior to the recruitment 
phase, our research team will initiate training seminars with ED staff at HUP and PPMC to discuss the 
purpose of the proposed study, to familiarize ED staff with the intake protocol and to ensure human 
subjects research requirements are met. The AA program staff at the HUP and PPMC will evaluate 
patients in the ED for eligibility to be screened. Our research team members who have completed 
appropriate trainings and have access to EPIC/PennChart may also participate in these seminars and 
recruit in the ED.  
 
Eligibility for screening will be determined via the ED tracking system using EPIC. AAs and trained 
research staff in the ED will review the tracking boards to identify patients age 21-39. This review is for 
screening purposes only. AAs and research staff will not review medical records for any patient. When 
an eligible patient is identified (age 21-39), they will check the tracking board and/or confirm with the 
treating physician or resident physician that the patient is fit to be approached for research (no altered 
mental status, no active intoxication, not too uncomfortable from pain, no unstable vital signs, no 
Emergency Severity Index (ESI) level 1 or 2). If the timing is clinically appropriate, the AA or research 
staff member will confirm with the treating physician that the interviewer will not interrupt the flow of 
care. Once confirmed, the interviewer will approach the patient to provide information about the study 
including the inclusion/exclusion criteria. If the timing is suitable and the patient is interested, the 
interviewer will proceed through the eligibility screening process and the informed consent procedure 
via electronic device (UPHS-approved tablet or laptop, or patients personal device) used to enroll the 
patient as a participant via Way to Health. The interview may be conducted with patients in a private 
room in the ED as they await discharge. For patients on the ward, the interview would also be 
conducted in a private room. For patients who are discharged before being enrolled, the enrollment 
process will continue electronically via the Way to Health platform. If its clinically appropriate to 
approach, but not enroll, the AA or research staff member may approach the patient to provide 
information about the study including the inclusion/exclusion criteria and obtain contact information for 
the study team to follow up at a later time. For patients who are discharged before completing the 
onboarding portion of the enrollment process (downloading apps, providing a photo of their ID, 

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receiving a breathalyzer) the AA or research staff member may take the patient to a private area in the 
HUP or PPMC lobby to complete this process. 
 
Following this, a member of the research team will contact the participant to answer any questions and 
send text message and email links to download the TrueMotion and BACtrack apps and mail the 
BACtrack device. If enrolled in the ED, the study staff member will set up an appointment with the 
participant to go through all of the enrollment steps. Staff will ensure full comprehension of study 
procedures and requirements during this call. Participants will also be asked to complete the intake 
survey to continue in the trial. The trial timeline will not begin until the intake has been completed, all 
apps have been installed and activated, and the BACtrack device has been received.  
 
Participants will be asked to complete 2 surveys outside of the weekly self-report survey using the Way 
to Health portal. They will be prompted via way to health to complete an intake survey and end of study 
survey at predetermined time points (following eligibility and consent and study completion 
respectively).  
 
Attached to this protocol are the following study instruments for data collection and recruitment: 1) 
Written Informed Consent 2) Eligibility Survey 3) Intake Survey 4) End of Study Survey 5) Weekly self-
report survey 
 
Data Management 
Describe how and who manages confidential data, including how and where it will be stored and 
analyzed. For instance, describe if paper or electronic report forms will be used, how corrections to the 
report form will be made, how data will be entered into any database, and the person(s) responsible for 
creating and maintaining the research database. Describe the use of pseudonyms, code numbers and 
how listing of such identifiers will be kept separate from the research data. 
 
Way to Health (Survey data): All personal information that the participant is asked to provide will be 
collected via Penn’s Way To Health study platform. Way To Health collects subjects names, dates of 
birth, addresses, email addresses, phone numbers, and the last four digits of their social security 
number. They also request the name and phone number of an alternate contact. To assure that 
participant confidentiality is preserved, individual identifiers are stored in a single password protected 
system that is accessible only to study research, analysis and IT staff. The last four digits of participant’s 
social security numbers will be stored in a locked cabinet to be destroyed at a later date. An investigator 
or statistician who logs in will be able to access only non-identifiable data. The Way To Health 
administrative group and research coordinators responsible for contacting participants for follow-up 
study visits or responding to questions about the study are able to view participant names and contact 
information. The WTH web development team and Project Director currently have administrative access 
to PHI. All of these personnel will have completed Human Subjects Protection and HIPAA privacy 
training. The system automatically generates logs of all data queries which can be reviewed by research 
staff to ensure that no unauthorized persons have gained access to identifiable information. 
 
This system is hosted on site at The University of Pennsylvania and is protected by a secure firewall and 
several layers of operational security. Once a participant has been entered into this system, they are 
given a unique study identification number (ID). Any datasets and computer files that leave the firewall 
are stripped of all identifiers and individuals are referred to by their study ID. The study ID is also used 
on all analytical files. The Penn Medicine Academic Computing Services (PMACS) is the hub for the 

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hardware and database infrastructure that supports the project and the Way To Health web portal is 
built on this infrastructure. The data collected for Way To Health based studies is stored in mySQL 
databases on a PMACS-operated blade server environment devoted specifically to Way To Health. The 
data center is housed in Information Systems and Computing at 3401 Walnut Street. All data are stored 
in a single relational database, allowing researchers to correct mistakes. Every SQL transaction, including 
accessing and changing data, is logged for auditing purposes. Data are entered into the database 
through several different mechanisms. Participants enter their own personal information and respond 
to surveys through a PHP-based web interface. Researchers have a separate interface that allows them 
to manually enter data if needed. Datasets are stripped of all personally identifiable information when 
exported for analysis. The web application automatically removes all identifiers when a researcher 
requests an analytic dataset. The only people with access to identifiable participant information are pre-
specified Research Coordinators responsible for contacting participants for follow-up. Personal 
information and research data will be stored in separate SQL tables and will be linked by a computer-
generated ID number. Additionally, any information that leaves this system to communicate with third 
party data sources (i.e. survey software) is stripped of any identifiers and transmitted in encrypted 
format.  
 
The same unique study ID is used to link these outside data to the participants. All data for this project 
will be stored on the secure/firewalled servers of the PMACS Data Center, in data files that will be 
protected by multiple password layers. These data servers are maintained in a guarded facility behind 
several locked doors, with very limited physical access rights. They are also cyber-protected by extensive 
firewalls and multiple layers of communication encryption. Electronic access rights are carefully 
controlled by UPenn system managers. Way To Health uses highly secure methods of data encryption 
for all transactions involving participant's financial information using a level of security comparable to 
what is used in commercial financial transactions. This multi-layer system of data security, identical to 
the system protecting the University of Pennsylvania Health Systems medical records, greatly minimizes 
the risk of loss of privacy. All communications between users and our site will be encrypted with 
SSL/HTTPs technology.  
 
TrueMotion (Driving data): TrueMotion requires users to enter in basic 
information to set up the account policy. This includes: Username Password Name Phone number 
Email The TrueMotion app currently tabulates the following data which are uploaded securely to the 
TrueMotion server: The following raw data fields organized at the timestamp level (clustered within 
drives, clustered within participants) will be transferred in CSV files in a way that can be securely 
downloaded in bulk by the University of Pennsylvania: Trip level data set with user ID and trip ID: 5. 
Start/stop time, location, and intensity of detected braking and acceleration events 6. Start/stop time, 
location, and intensity of speeding events (excess speed relative to an absolute threshold or relative to 
local speed limits) 7. OS-level events like screen on, screen unlock, call state 8. Start/stop time and 
location of detected distraction events using our sensor-based algorithms: phone calls (with a detection 
of in-hand versus hands-free) and general non-call usage like tapping, typing. As far as the time-series 
sensor data which can be linked with a user ID and trip ID, TrueMotion will provide: 2. GPS points (lat/ 
lon position, speed, accuracy, etc) at 1 Hz 3. IMU sensor data (3-axis accelerometer, gyroscope, and 
magnetometer) at 9 Hz Using an established secure data transfer, data collected by the TrueMotion app 
will be posted on a secure FTP server managed by TrueMotion. Our study team has been granted 
password access to pull these data onto PMACS server in one week increments. Data will not be tracked 
or analyzed in real time.  
 

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BACTtrack (Breathalyzer Data) We collect time-stamped and geocoded data on breath alcohol 
content using the BACTrack App which pairs with the FDA approved BACtrack Mobile Pro. Each 
participant will be instructed to download the BACTrack View app from the Apple App store and register 
a uniquely assigned, de-identified study email (e.g. besafe24@waytosafety.org) to create a BACTrack 
account. Participants will need to accept the BACTrack privacy policy and accept the option to share 
data with BACtrack. No identifying HIPAA sensitive information will be entered into BACTrack app 
registration portal by study participants. BACtrack will provide the University of Pennsylvania a weekly 
download of all data collected from designated user accounts (prefix besafe) via access to BACtracks 
secure Box folder. These password protected CSV files will be downloaded from the BACtracks Box 
folder by the UPenn research coordinator on a weekly basis and be inputted into Way to Health. This 
includes the de-identified user ID (e.g. besafe24), timestamped and geocoded guessed and actual BAC 
measurements. In addition to the BACTrack privacy policy outlines that personally identifiable 
information (account names) will not be shared with outside parties, we will also obtain an NIH 
Certificate of Confidentiality that will protect the University of Pennsylvania from disclosing this 
potentially sensitive information to any third parties. 
 
 
Radiation Exposure* 
Are research subjects receiving any radiation exposure (e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, 
FDG, Tc-99m, etc.) that they would not receive if they were not enrolled in this protocol? 
No 
 
Human Source Material* 
Does this research include collection or use of human source material (i.e., human blood, blood 
products, tissues or body fluids)? 
No 
 
CACTIS and CT Studies* 
Does the research involve Center for Advanced Computed Tomography Imaging Services (CACTIS) 
and CT studies that research subjects would not receive if they were not part of this protocol? 
No 
 
CAMRIS and MRI Studies* 
Does the research involve Center for Advanced Magnetic Resonance Imaging and Spectroscopy 
(CAMRIS) and MRI studies that research subjects would not receive if they were not part of this 
protocol? 
No 
 
Cancer Related research not being conducted by an NCI cooperative group* 
Does this protocol involve cancer-related studies in any of the following categories? 
No 
 
Medical Information Disclosure* 
Does the research proposal involve the use and disclosure of research subject's medical information for 
research purposes? 
No 
 

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CTRC Resources* 
Does the research involve CTRC resources? 
No 
 
If the answer is YES, indicate which items is is provided with this submission: 
Use of UPHS services* 
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures*, whether considered routine care or strictly for research purposes? 
No 
 
Primary Focus* 
Sociobehavioral (i.e. observational or interventional) 
 
Protocol Interventions 
x Sociobehavioral (i.e. cognitive or behavioral therapy) 
  Drug 
  Device - therapeutic 
  Device - diagnostic (assessing a device for sensitivity or specificity in disease diagnosis) 
  Surgical 
  Diagnostic test/procedure (research-related diagnostic test or procedure) 
  Obtaining human tissue for basic research or biospecimen bank 
x Survey instrument 
  None of the above 
 
Sponsors 
 
Business Administrator 
Name: MOORE, ELIZABETH 
Dept / School / Div: 4302 - EG-Emergency Medicine 
Phone: 215-898-6409 
Fax: 215-898-0868 
Pager: 
Email: EMOORE@POBOX.UPENN.EDU 
 
Department budget code 
000 - 000 - 0 - 000000 - 0000 - 0000 – 0000 
 
Funding Sponsors 
Name: UNIVERSITY OF PENNSYLVANIA 
Type: UPENN Internal 
 
Funding sponsors billing address 
If you have selected a commercial or industry sponsor, please provide the appropriate address and 
contact information for the Sponsor for the purposes of billing for IRB review fees (initial review, 
continuing review and convened modification fees apply here). If the Sponsor is not industry/ 
commercial, this information is not necessary to provide with your application. 

V4; 10.4.17 
University of Pennsylvania Transdisciplinary Awards Program in Translational Medicine and 
Therapeutics (TAPITMAT) Program in Incentive Based Translational Science (IBTS) 2016 
 
Funding sponsors gift 
Is this research being funded by a philanthropic gift? 
No 
 
Regulatory Sponsor 
IND Sponsor 
None 
 
000 - 000 - 0 - 000000 - 0000 - 0000 – 0000 
 
Industry Sponsor 
None 
 
Project Funding* 
Is this project funded by or associated with a grant or contract? 
No 
 
Sponsor Funding 
Is this study funded by an industry sponsor? 
Status of contract 
 
Multi-Site Research 
Other Sites 
No other sites 
 
Protocol 
 
Abstract 
 
Nearly 88,000 people die annually from alcohol-related causes, making it the third leading cause of 
preventable death in the US.1 Excessive alcohol consumption is a major risk factor for injury, assault, 
and suicide. Framed messaging, whether through leveraging health gains or loss aversion, has been 
found to be effective in motivating people to complete certain activities such as quitting smoking,to 
purchasing select items, and preventative behaviors like using sunscreen. 10,36,37  However, theymay not 
be as effective in other areas such as food choice.14 The next logical step, which is the goal of this 
project, is to demonstrate the feasibility of a scalable intervention using loss- or gain-framed messaging 
to reduce drinking and driving, compare the effectiveness of each type of messaging,  and to increase 
the use of a personal BAC monitor. Our long-term objective is to secure federal funding for research that 
leverages insights from behavioral economics supported by smartphone technology to reduce risky 
drinking, drinking and driving, and to increase self-monitoring and understanding of how alcohol affects 
us. This long-term objective is consistent with the recently released FY 2016-20 NIH Strategic Vision that 
strives to deliver effective mobile health (mHealth) technologies for health promotion and disease 

V4; 10.4.17 
prevention and monitoring blood-alcohol levels in real time to prevent alcohol-related injury and 
disease. 
 
Objectives 
 
Overall objectives 
 
The overall objective of this project is to leverage smartphone-paired breathalyzers to implement cost-
effective and scalable behavioral interventions to reduce risky drinking behaviors such as drinking and 
driving. Prospect theory proposes that messages framed in different ways can elicit different responses 
from individuals.36 Loss aversion refers to people's tendency to prefer avoiding losses to acquiring 
equivalent gains: it's better to not lose $5 than to find $5. People are more motivated to avoid losing 
something than they are to win something. Studies have found that delivering messaging framed as a 
loss are also effective in motivating certain behaviors. On the other hand, gain-framed messages have 
been shown to have a positive effect on preventative healthcare.37 By using automated remote 
monitoring, innovative loss aversion and gain-framed messaging strategies incorporating insights from 
behavioral economics could be more easily implemented by delivering effective messaging prior to a 
risky behavior taking place. We hope that the use of loss aversive and/or gain-framed messaging will 
lead to individuals improving planning behavior around drinking, especially in regards to drinking and 
driving. The objective of this project is to demonstrate the feasibility of a scalable intervention using 
loss- gain-framed messaging to reduce drinking and driving, compare the effectiveness of each type of 
messaging, and to increase the use of BAC monitors as a way to plan safer strategies when drinking. Our 
long-term objective is to secure federal funding for research that leverages insights from behavioral 
economics supported by smartphone technology to reduce risky drinking. This long-term objective is 
consistent with the recently released FY 2016-20 NIH Strategic Vision that strives to deliver effective 
mobile health (mHealth) technologies for health promotion and disease prevention and monitoring 
blood-alcohol levels in real time to prevent alcohol-related injury and disease. 
 
Primary outcome variable(s) 
The primary outcome will be: Change in proportion of breathalyzer measurements submitted with self-
reported drinking episodes across groups. 
 
Secondary outcome variable(s) 
Secondary outcomes will be: 1) Change in frequency of BACtrack monitoring within each intervention 
group from baseline; 2) Drinking and driving episodes in which their BAC via self-report or BAC measure 
is expected to be positive; 3) Changes in accuracy of BAC guess vs actual BAC measure with continued 
use (Does a participant become more accurate overtime in predicting what their BAC will be prior to 
measuring). Lack of previous research prevents us from calculating the power to detect the drinking and 
driving outcomes, which is why this pilot trial is critical for securing future funding. 
 
Background 
 
Nearly 88,000 people die annually from alcohol-related causes, making it the third leading cause of 
preventable death in the US.1 Excessive alcohol consumption is a major risk factor for injury, assault, and 
suicide. In 2013, 10,076 people were killed in drinking and driving-related motor vehicle crashes, 
accounting for one-third of all driving-related deaths.5  Individuals who engage in drinking and driving, 
compared to those do not, have similar cognitive abilities, actually understand legal consequences 

V4; 10.4.17 
better, but are poorer planners and more present-biased, heavily weighing immediate costs and 
benefits relative to future ones when making decisions.6 This suggests that strategies such as planning a 
designated driver and providing immediate reinforcement of the benefit of moderating alcohol 
consumption are particularly promising approaches to reduce drinking and driving and binge drinking. 
Nationally, 17% of individuals aged 18 and older report binge drinking in the past month.7,8  Importantly, 
binge drinkers are 14 times more likely to report alcohol-impaired driving than non-binge drinkers.9  
Prospect theory proposes that messages framed in different ways can elicit different responses from 
individuals.36 Loss aversion refers to people's tendency to prefer avoiding losses to acquiring equivalent 
gains: it's better to not lose $5 than to find $5. People are more motivated to avoid losing something 
than they are to win something. Studies have found that delivering messaging framed as a loss are also 
effective in motivating certain behaviors. On the other hand, gain-framed messages have been shown to 
have a positive effect on preventative healthcare.37 By using automated remote monitoring, innovative 
loss aversion and gain-framed messaging strategies incorporating insights from behavioral economics 
could be more easily implemented by delivering effective messaging prior to a risky behavior taking 
place. The effectiveness of this messaging relies on being able to deliver a well-designed, motivating 
messaging prior to the risky behavior occurring and to have an easy to measure behavior as an indicator 
of success. As alcohol is metabolized more quickly than most drugs, making it difficult to monitor in the 
community and self-report of drinking and driving incidents can be underestimated these are not 
desirable metrics to use alone. A recent trial demonstrated the feasibility of sending text message 
videos of personalized breathalyzer readings in non-dependent frequent drinkers.12 However, this 
process is difficult to scale up as study staff had to confirm breathalyzer readings manually in videos sent 
by participants. In the last two years, breathalyzers that pair with smartphones have come on the 
market,17,19 allowing individuals to monitor and more easily track their own breath alcohol concentration 
(BrAC). Given the popularity of these devices,20,21 booming sales (an $816 million dollar market),22 and 
the ability to share the data they generate in a secure and automated fashion, the devices could be used 
to as a way to measure the effectiveness of interventions aimed at reducing risky drinking on a much 
broader scale. 
 
Real time knowledge of your level of intoxication could help educate the population and lead to better 
planning behavior, reducing incidents of drinking and driving. One difficulty in using these devices to this 
end is that users may not be inclined to measure their BAC when it matters most. The information 
provided by BAC monitors is only effective if it is being used. Combining these devices with innovative 
strategies that incorporate insights from behavioral economics to deliver loss averse messaging prior to 
a risky behavior taking place could not only increase self-monitoring but could have a significant impact 
on planning behavior as well.23,24 Communication and framing are important in health care, how 
messages are framed can impact behavior.35 A nutritional study on children found educational messages 
paired with loss framed messages, gain framed messaged, and a small incentive positively impact 
behavior change.34 To date, there are no published studies testing the use of messaging to increase the 
use of smartphone-paired breathalyzers. Our cross-disciplinary research group at Penn recently 
obtained funding to conduct what will be the first peer-reviewed study to validate the test accuracy of 
the leading smartphone-paired breathalyzers on the market against a policy grade breathalyzer. The 
next logical step, which is the goal of this project, is to demonstrate the feasibility of a scalable 
intervention using messaging to increase the use of the monitors.      
 
References 
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www.niaaa.nih.gov.  

V4; 10.4.17 
2. Easton, C.J., Swan, S., & Sinha R. Prevalence of family violence in clients entering substance abuse 
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5. National Highway Traffic Safety Administration. Traffic Safety Facts: Alcohol-Impaired Driving.; 2015. 
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or Older, by Demographic Characteristics: Percentages, 2013 and 2014.; 2015. 
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41b.  
8. Centers for Disease Control and Prevention. BRFSS Prevalence & Trends Data.; 2015. 
http://www.cdc.gov/brfss/brfssprevalence/ .  
9. Naimi TS, Brewer RD, Mokdad A, Denny C, Serdula MK, Marks JS. Binge drinking among US adults. 
JAMA. 2003;289(1):70-75.  
10. Matjasko, J. L. et al. Applying Behavioral Economics to Public Health Policy. American Journal of 
Preventive Medicine , Volume 50 , Issue 5 , S13 - S19.  
11. Schneider, T.R.; Salovey, P.; Apanovitch, A.M.; Pizarro, J.; McCarthy, D.; Zullo, J.; Rothman, A.J. The 
effects of message framing and ethnic targeting on mammography use among low income women. 
Health Psychology, Vol 20(4), Jul 2001, 256-266  
12. Toll, B.A.; O'Malley, S.S.; Katulak, N.A.; Wu, R.; Dubin, J.A.; Latimer, A.; Meandzija, B.; George, T.P.; 
Jatlow, P.; Cooney, J.L.; Salovey, P. Comparing gain- and loss-framed messages for smoking cessation 
with sustained-release bupropion: A randomized controlled trial. Psychology of Addictive Behaviors, Vol 
21(4), Dec 2007, 534-544.  
13. Blose, J.E., Mack, R.W. , Pitts, R.E. The Influence of Message Framing on Hotel Guests Linen-Reuse 
Intentions. Cornell Hospitality Quarterly, Vol 56, Issue 2, pp. 145 - 154  
14. List, J.A., Samek, A.S. The behavioralist as nutritionist: Leveraging behavioral economics to improve 
child food choice and consumption. Journal of Health Economics 39 (2015) 135146.  
15. MacKillop J, Amlung MT, Few LR, Ray LA, Sweet LH, Munafò MR. Delayed reward discounting and 
addictive behavior: a meta-analysis. Psychopharmacology (Berl). 2011;216(3):305-321. 
doi:10.1007/s00213-011-2229-0.  
16. Petry NM, Martin B, Cooney JL, Kranzler HR. Give them prizes and they will come: Contingency 
management for treatment of alcohol dependence. J Consult Clin Psychol. 2000;68(2):250-257. 
doi:10.1037/0022-006X.68.2.250.  
17. Alcohoot Smartphone Breathalyzer. Alcohoot. http://alcohoot.com/products/alcohoot-breathalyzer. 
Accessed December 24, 2015.  
18. BACtrack Mobile Pro. BACtrack. http://www.bactrack.com/products/bactrack-mobile-
breathalyzer?gclid=Cj0KEQiAzO6zBRC25Ju1idGJiZkBEiQAP3Sf6MVZKaULJEmXCJnBgqXvqrzfuiYe3hpIEsg
Mir1_QXUaAl_o8P8HAQ. Accessed December 24, 2015.  
19. Breathometer. Breathomter Breeze. http://store.breathometer.com/products/breeze. Accessed 
December 24, 2015.  

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20. Jolly J (New YT. Turning Your Smartphone into a Breathalyzer. New York Times. 
http://well.blogs.nytimes.com/2015/12/21/turning-your-smartphoneinto-a-breathalyzer/?smid=fb-
nytimes&smtyp=cur&_r=1. Published December 21, 2015.  
21. A smartphone breathalyzer. USA Today. 2015. 
http://www.usatoday.com/videos/tech/2013/05/19/2216497/. Accessed January 4, 2016.  
22. Wintergreen Research. Alcohol Breathalyzer And Drug Testing Equipment: Market Shares, Strategies, 
and Forecasts, Worldwide, 2014 to 2020. 2016. 
http://wintergreenresearch.com/alcohol_breathalyzer_and_drug_testing.  
23. Loewenstein G, Brennan T, KG V. ASymmetric paternalism to improve health behaviors. JAMA. 2007; 
298 (20):2415-2417. http://dx.doi.org/10.1001/jama.298.20.2415.  
24. MS P, DA A, KG V. WEarable devices as facilitators, not drivers, of health behavior change. JAMA. 
2015; 313(5):459-460. http://dx.doi.org/10.1001/jama.2014.14781.  
25. NIH Unveils FY2016-2020 Strategic Plan.; 2015. http://www.nih.gov/news-events/news-
releases/nih-unveils-fy2016-2020-strategic-plan.  
26. University of Pennsylvania. Faculty and Staff. http://www.med.upenn.edu/ccc/faculty.html#curtis. 
Accessed March 15, 2016.  
27. CellControl. Technology to eliminate texting, emailing and unauthorized phone use while 
driving. https://www.cellcontrol.com/company-fleet-safety-distracted-driving-prevention. Accessed 
March 15, 2016.  
28. Uber. Uber Events. 2016. https://www.uber.com/events.  
29. Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when 
administered by telephone and by computer. Drug Alcohol Depend. 1996;42(1):49-54.  
30. MA C, HA B, KG V, MS P.ACcuracy of smartphone applications and wearable devices for tracking 
physical activity data. JAMA. 
2015;313(6):625-626. http://dx.doi.org/10.1001/jama.2014.17841.  
31. South EC, Kondo MC, Cheney RA, Branas CC. Neighborhood Blight, Stress, and Health: A Walking Trial 
of Urban Greening and Ambulatory Heart Rate. Am J Public Health. 2015;105(5):909-913. 
doi:10.2105/AJPH.2014.302526. 
32. Byrnes HF, Miller BA, Wiebe DJ, Morrison CN, Remer LG, Wiehe SE. Tracking Adolescents With 
Global Positioning System-Enabled Cell Phones to Study Contextual Exposures and Alcohol and 
Marijuana Use: A Pilot Study. J Adolesc Heal. 2015;57(2):245-247. doi:http://dx.doi.org/10.1016/ 
j.jadohealth.2015.04.013.  
33. Patel MS, Asch DA, Rosin R, et al. Framing Financial Incentives to Increase Physical Activity Among 
Overweight and Obese AdultsA Randomized, Controlled Trial Financial Incentives for Physical Activity in 
Overweight and Obese Adults. Ann Intern Med. 2016;164(6):385-394. http://dx.doi.org/10.7326/M15-
1635. 
34. List JA, Samek AS. The behavioralist as nutritionist: Leveraging behavioral economics to improve 
child food choice and consumption. Journal of health economics. 2015 Jan 31;39:135-46. 
https://doi.org/10.1016/j.jhealeco.2014.11.002  
35. Rothman AJ, Bartels RD, Wlaschin J, Salovey P. The strategic use of gain‐and loss‐framed messages to 
promote healthy behavior: How theory can inform practice. Journal of communication. 2006 Aug 
1;56(s1). 10.1111/j.1460-2466.2006.00290.x 
36. Tversky, A., & Kahneman, D. (1981). The framing of decisions and the psychology of choice. Science, 
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37. Rothman, A. J., & Salovey, P. (1997). Shaping perceptions to motivate healthy behavior: The role of 
message framing. Psychological Bulletin, 121(1), 3-19. http://dx.doi.org/10.1037/0033-2909.121.1.3 
 

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Study Design 
 
Phase* 
Not applicable 
 
Design 
 
Study population: We will recruit 60 participants for this trial. Participants must be (a) over 21 years of 
age, (b), Reports an average of one heavy drinking day (men more than five drinks, women more than 
four drinks) per week over the preceding 8 weeks. (d) a valid photo ID (e) willing and able to use an 
Uber or Lyft or septa as transportation home (f) drives four or more trips per week (g) and owns an 
Apple iPhone or Android smartphone. Participants will be excluded if they (a) desire alcohol treatment 
now or received it in the past 6 months, (b) alcohol use disorder per DSM-V criteria and (c) non-English-
speaking, and (d) women who are pregnant (e) individuals who should not consume alcohol due to a 
medical condition.  
 
Procedures: Participants will be provided with a smartphone-paired breathalyzer (BACtrack) and a 
smartphone app that tracks (TrueMotion) driving behavior. The drive tracking app has been modified for 
research purposes to run completely in the background with special privacy protections for research 
participants with an approved NIH Certificate of Confidentiality.  
 
Data and information will be collected in 3 ways throughout this study:  
1) The BACtrack device and app will require the participant to initiate use during all phases of the trial. 
Researchers will instruct participants to use this device during the study when drinking to help inform 
them of their level of impairment and ability to operate a vehicle. As part of the BACtrack app each 
participant will be asked to guess what their BAC is prior to submitting a sample. Once a sample is 
submitted and processed the app will display both the actual BAC measure as well as the participants 
guess. They will also be able to indicate of the sample was provided by them or someone else. Data 
collected using this app and device includes guessed BAC, actual BAC, person submitting the sample, 
GPS coordinates, and timestamps.  
 
2) The TrueMotion app will collect participant driving data without any additional initiation by the 
participant. Data collected from this app will include GPS coordinates, driving speed, trip length, time of 
drive, and cellphone use while driving. During a drive or after its completion participants will be able to 
indicate if they are a passenger or a driver.  
 
3) Self-report in the form of a TLFB will be collected once a week for all participants. Each week 
participants will be asked to complete a brief survey on the Way to Health site that asks them about 
drinking events, drinking and driving events, and BACtrack use for the previous week  
 
Participants will be given educational information on the risks of drinking and will be randomized, using 
block randomization, to a control or one of two intervention groups for 8 weeks. Participants will be 
blinded as to their group assignment. Participants in the intervention groups will receive messages on 
Thursday, Friday, and Saturday before 6:00 PM and will be informed of this random selection in the 
consent. For the intervention groups, the context of these messages will differ across each group and 
participants will not be alerted to this difference. Specifically, the consent will state that researchers will 

V4; 10.4.17 
test the effect of different messaging strategies on the use of self-monitoring. Text messages will be 
delivered 3 days a week—Thursday, Friday, and Saturday—through the Way to Health platform and 
Twilio, a texting service that is contracted through Way to Health.  
 
This program does not encourage drinking and driving, in fact it is designed in hopes that participants 
will be more informed about their level of intoxication and their ability to drive. Additionally, messages 
delivered following a positive BAC reading highlights the dangers and risks of a DUI. Attached to this 
protocol are examples of these messages.  
 
Measures and Data Analysis. Participants will complete a baselineand end of study survey via Way to 
Health with standard measures of drinking and driving behavior, measures of planning ability, a delay 
discounting task, and demographic variables. Time-stamped and geocoded drive trip data will be 
obtained from the TrueMotion app. Self-reported drinking behavior will be recorded weekly using the 
timeline follow back method.  
 
The primary outcome measure will be the change in proportion of breathalyzer measurements 
submitted with self-reported drinking episodes across groups.  
 
Secondary outcomes will be: 1) Change in frequency of BACtrack monitoring within each intervention 
group from baseline; 2) Drinking and driving episodes in which their BAC via self-report or BAC measure 
is expected to be positive; 3) Changes in accuracy of BAC guess vs actual BAC measure with continued 
use (Does a participant become more accurate overtime in predicting what their BAC will be prior to 
measuring). Lack of previous research prevents us from calculating the power to detect outcome #3, 
which is why this pilot trial is critical for securing future funding.  
 
We will use logistic regression as our primary analytic model to assess effectiveness, between and within 
the interventions. Although longitudinal models such as generalized estimating equations might be 
considered in light of the repeated measures among individual participants, logistic regression is 
preferred in this case because the primary outcome collapses most time points into a single 
dichotomous measure. Approach to missing data: As our main outcome in this trial is the proportion of 
measures conducted overtime, missing data will be scored as not completing a measurement.  
 
Participants missing weekly self-report surveys will be reminded to complete a TLFB for any missing 
weeks regularly. If a participant fails to complete 75% of the self-report surveys under baseline 
conditions they will not be allowed to continue to the intervention phase. If participants who have 
moved to the intervention phase fail to complete self-report data during the intervention phase 
estimates on drinking behavior can be derived from their baseline data. 
 
Study duration 
Participants will be enrolled for eight weeks in the study. The projected start date of the study is 
September 1, 2017 and the date of completion is March 1, 2018. 
 
Resources necessary for human research protection 
Describe research staff and justify that the staff are adequate in number and qualifications to conduct 
the research. Describe how you will ensure that all staff assisting with the research are adequately 
informed about the protocol and their research related duties. Please allow adequate time for the 

V4; 10.4.17 
researchers to conduct and complete the research. Please confirm that there are adequate facilities for 
the research. 
The project manager will oversee all study operations and research assistants will be trained in the 
protocol and present at the study sessions. All research staff will be fully trained in the pilot protocol 
and their role in the study, will be supervised by the PI, Dr. Mucio (Kit) Delgado, MD (Assistant 
Professor of Emergency Medicine), and will be trained to refer patients to the appropriate provider 
(emergency department, outpatient doctor/clinic, social worker) as warranted. 
 
Characteristics of the Study Population 
 
Target population 
We will recruit 60 participants for this trial. Participants must be (a) over 21 years of age, (b), Reports an 
average of one heavy drinking day (men more than five drinks, women more than four drinks) per week 
over the preceding 8 weeks. (d) a valid photo ID (e) willing and able to use an Uber or Lyft or septa as 
transportation home (f) drives four or more trips per week (g) and owns an Apple iPhone or Android 
smartphone. Participants will be excluded if they (a) desire alcohol treatment now or received it in the 
past 6 months, (b) alcohol use disorder per DSM-V criteria and (c) non-English-speaking, and 
(d) women who are pregnant (e) individuals who should not consume alcohol due to a medical 
condition. 
 
Subjects enrolled by Penn Researchers 
60 
 
Subjects enrolled by Collaborating Researchers 
0 
 
Accrual 
It is expected that the majority of subjects will volunteer to participate after responding to IRB approved 
advertisements on mass transit and broadcast email messages at institutions (including the 
University of Pennsylvania Health System) that offer such a service; and by posting/distributing 
recruitment materials in community settings with public posting areas or other means of providing 
community access to materials (such as hospitals, town halls, public libraries, YMCAs, health fairs/ 
organizations). Research assistants will hand out fliers for the study in approved public and private 
locations. Research assistants will recruit participants by handing out information in crowded places, 
such as on the street or near bars. No one will be approached to participate who appears intoxicated.  
 
Participants recruited at the hospital will be introduced to the study by a dedicated member of the study 
team and provided with a link to the Way to Health website. The academic associates or research 
assistant will introduce the study to eligible patients and provide them with an iPad to administer a brief 
eligibility screening (if applicable). If eligible for the study participants will be instructed to review and 
sign the full consent for participation, if willing.  
 
And No recruitment will occur at public or private places without first obtaining permission. 
Recruitment materials may also be posted on social media and in newsletters and postings. Social media 
can include Facebook, Twitter, Snapchat, Craigslist, and other outlets as they become available. 

V4; 10.4.17 
Newsletters can include internal UPenn postings and newsletters sent by organizations who agree to 
share our recruitment information. 
 
Key inclusion criteria 
Inclusion criteria will be: (a) over 21 years of age, (b), Reports an average of one heavy drinking day 
(men more than five drinks, women more than four drinks) per week over the preceding 8 weeks. (d) a 
valid photo ID (e) willing and able to use an Uber or Lyft or septa as transportation home (f) drives four 
or more trips per week (g) and owns an Apple iPhone or Android smartphone. Participants will be 
excluded if they (a) desire alcohol treatment now or received it in the past 6 months, (b) severe alcohol 
use disorder (AUD) per DSM-V criteria (6 or more AUD symptoms reported)and (c) non-English-speaking, 
and (d) women who are pregnant (e) individuals who should not consume alcohol due to a medical 
condition such as liver disease, cancer, and seizure disorders. Participants will be asked to answer yes if 
they have any disorder that their doctor has suggested that they should not drink alcohol. If they are 
unsure or say I dont know we will ask them to speak with their doctor prior to participation. 
 
Key exclusion criteria 
Exclusion criteria will be (a) desire alcohol treatment now or received it in the past 6 months, (b) severe 
alcohol use disorder per DSM-V criteria (6 or more AUD symptoms reported) and (c) non-English-
speaking, and (d) women who are pregnant (e) individuals who should not consume alcohol due to a 
medical condition. 
 
Vulnerable Populations 
   Children Form 
   Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
   fetus) Form 
   Fetuses and/or Neonates Form 
   Prisoners Form 
   Other 
x None of the above populations are included in the research study 
 
Populations vulnerable to undue influence or coercion 
This study may enroll employees or students of Penn. These participants will not be recruited directly or 
incentivized differently than other subjects in the study. During informed consent study staff will review 
the voluntary nature of their participation and reminded that they are able to leave the study at any 
time during the study procedures. 
 
Subject recruitment 
 
Subjects for this study will be recruited primarily from individuals who present themselves for evaluation 
for study inclusion by calling our research facility. It is expected that the majority of subjects will 
volunteer to participate after responding to IRB-approved advertisements on mass transit; and 
broadcast email messages at institutions (including the University of Pennsylvania Health System) that 
offer such a service; and by posting/distributing recruitment materials in community settings with public 
posting areas or other means of providing community access to materials (such as hospitals, town halls, 
public libraries, YMCAs, health fairs/organizations). Research assistants will hand out fliers for the study 

V4; 10.4.17 
in approved public and private locations. We will obtain permission before distributing or posting the 
approved recruitment materials. 
 
For participants recruited at the hospital, those who are eligible will be introduced to the study by a 
dedicated member of the study team and provided with a link to the Way to Health website. The 
academic associates or research assistant will introduce the study to eligible patients and provide them 
with an iPad to administer a brief eligibility screening (if applicable). If eligible for the study participants 
will be instructed to review and sign the full consent for participation, if willing. They will then schedule 
an appointment to review the enrollment procedures over the phone with a study team member. This 
can also be done in person if the participant requests. If enrollment is completed in person, the 
participant will be provided their BACtrack breathalyzer and Clincard. 
 
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research? 
Yes 
 
Please identify which method(s) of social media you will utilize, the content of the text to be used, and 
the method(s) for posting this information (i.e., using Penn supported communication services). When 
proposing the text to utilize, please be aware of any social media limitations (i.e., number of characters 
allowed in a tweet) and any appropriate confidentiality practices necessary to be compliant with posting 
research recruitment text.* 
We plan to use Facebook and Twitter to post recruitment messages. These messages are severely 
limited in terms of the length they can be. Our message will be "Help Upenn researchers reduce drinking 
and driving while earning money" and will include a link to the WTH study portal that will contain more 
information such as that listed on our recruitment flyer. We also plan to post our recruitment flyer on 
Craigslist. 
 
Study Procedures 
 
Suicidal Ideation and Behavior 
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)? 
No 
 
Procedures 
 
Enrollment: Potential participants will be directed to the Way to Health platform. A participant will 
create an account and review an Eligibility screening consent. This brief consent will grant us access to 
administer a brief eligibility survey. We have decided to use this process to reduce the time needed to 
read the full consent for those who may not qualify. Once eligibility has been determined eligible 
participants will be instructed to review and sign the full consent for participation. Following this, a 
member of the research team will contact the participant to answer any questions and to mail out the 
BACtrack device. Participants will also be asked to complete the intake survey to continue in the trial. 
The trial timeline will not begin until the intake has been completed and all devices and apps have been 
received and activated.  

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Randomization: Once participants have received and activated their devices they will be placed into 
the baseline phase of the trial for 4 weeks. Following baseline, if the participants have completed 75% of 
their self-report measures they will be randomized to one of three groups: a) control, b) loss-framed 
messaging group, or c) gain-framed messaging group.  
 
Baseline Measurement: During the baseline period, the TrueMotion app will passively track driving 
behavior and participants. Participants will not receive any information on whether to use their 
BACtrack device. At the end of the baseline measurement period participants will complete an end of 
Baseline survey via way to health.  
 
Intervention Period: After four weeks, participants will be randomized into one of three arms: control, 
loss-framed messaging group, or gain-framed messaging group.  
 
Weekly Surveys: Each week, under both phases, participant will be prompted to complete a self-report 
survey and TLFB. 
 
 
Deception 
Does your project use deception? 
No 
 
Analysis Plan 
 
Measures and Data Analysis. Participants will complete a baseline, end of baseline period, and end of 
study survey via Way to Health with standard measures of drinking and driving behavior, measures of 
planning ability, a delay discounting task, and demographic variables. Time-stamped and geocoded drive 
trip data will be obtained from the TrueMotion app. Self-reported drinking behavior will be recorded 
weekly using the timeline follow back method. 
 
Primary outcome: The primary outcome measure will be the change in proportion of breathalyzer 
measurements submitted with self-reported drinking episodes across groups. 
Secondary outcome measures include: 1) Change in frequency of BACtrack monitoring within each 
intervention group from baseline; 2) Drinking and driving episodes in which their BAC via self-report or 
BAC measure is expected to be positive; 3) Changes in accuracy of BAC guess vs actual BAC measure 
with continued use (Does a participant become more accurate overtime in predicting what their BAC will 
be prior to measuring). Lack of previous research prevents us from calculating the power to detect the 
drinking and driving outcomes, which is why this pilot trial is critical for securing future funding. 
To measure the primary outcome, we will employ a logistic regression using the participants baseline as 
a predictor and the intervention vs. control and vs each other as the primary predictors. Although 
longitudinal models such as generalized estimating equations might be considered in light of the 
repeated measures among individual participants, logistic regression is preferred in this case because 
the primary outcome collapses most time points into a single dichotomous measure. 

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Approach to missing data: As our main outcome in this trial is the proportion of measures conducted 
overtime, missing data will be scored as not completing a measurement. Participants missing weekly 
self-report surveys will be reminded to complete a TLFB for any missing weeks regularly. If a participant 
fails to complete 75% of the self-report surveys under baseline conditions they will not be allowed to 
continue to the intervention phase. If participants who have moved to the intervention phase fail to 
complete self-report data during the intervention phase estimates on drinking behavior can be derived 
from their baseline data. 
 
Data confidentiality 
x Paper-based records will be kept in a secure location and only be accessible to personnel involved 
   in the study. 
x Computer-based files will only be made available to personnel involved in the study through the 
   use of access privileges and passwords. 
   Prior to access to any study-related information, personnel will be required to sign statements 
   agreeing to protect the security and confidentiality of identifiable information. 
x Wherever feasible, identifiers will be removed from study-related information. 
x A Certificate of Confidentiality will be obtained, because the research could place the subject at 
   risk of criminal or civil liability or cause damage to the subject's financial standing, 
   employability, or liability. 
   A waiver of documentation of consent is being requested, because the only link between the 
   subject and the study would be the consent document and the primary risk is a breach of 
   confidentiality. (This is not an option for FDA-regulated research.) 
x Precautions are in place to ensure the data is secure by using passwords and encryption, because 
   the research involves web-based surveys. 
x Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
   identification of subjects. 
 
Subject Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies on subject privacy and the Investigator and other site personnel will not use such 
data and records for any purpose other than conducting the study. The safeguards described above will 
be implemented to ensure subject confidentiality. No identifiable data will be used for future studies 
without first obtaining IRB approval. The investigator will obtain a data use agreement between provider 
(the PI) and any recipient researchers (including others at CHOP) before sharing a limited dataset (dates 
and zip codes). We will be collecting licenses through the secure Way to Health portal to verify that all 
participants are licensed to drive. We will destroy these images when the participant study participation 
is complete, no more than 1 week after their final survey completion 
 
Sensitive Research Information* 
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record? 
No 
 
Subject Privacy 

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Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas confidentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact 
potential participants. The settings in which an individual will be interacting with an investigator. The 
privacy guidelines developed by relevant professions, professional associations and scholarly disciplines 
(e.g., psychiatry, genetic counseling, oral history, anthropology, psychology). 
Privacy is of the utmost concern for us. In this trial every participant will be assigned a participant 
number, this will link their study related data. We will not release any names or information to anyone 
outside of this study. Participants will complete all surveys online and will not be required to attend any 
in person sessions. We will allow for participants to be placed on teams with unknown others if they 
chose and will never release their names to team members. We will include all risks associated with 
participating such as the potential risk of personal information being obtained in the consent for each 
participant to consider. 
 
Data Disclosure 
Will the data be disclosed to anyone who is not listed under Personnel? 
No. Participant BrAC measurements and survey responses from participants will not be linked to 
participant identifying information, and data will be available only for study personnel. However, all 
potential subjects will be informed that the information they provide will be held in confidence to the 
extent that the law allows, but that the exception to this confidentiality is any disclosure of potential for 
immediate harm of themselves or others, such as active suicidal or homicidal ideation or child abuse. 
The participants will be notified prior to participation that if any of these issues are raised, the 
researchers will take whatever steps are necessary to protect the subject or others, including bringing 
risk of harm to the attention of the proper authorities. As an emergency physician, Dr. Delgado is 
experienced with assessing this type of risk and committing patients or notifying child protective 
services or law enforcement when necessary. 
 
Data Protection* 
x Name 
x Street address, city, county, precinct, zip code, and equivalent geocodes 
   All elements of dates (except year) for dates directly related to an individual and all ages over 89 
x Telephone and fax number 
x Electronic mail addresses 
x Social security numbers 
   Medical record numbers 
   Health plan ID numbers 
   Account numbers 
   Certificate/license numbers 
   Vehicle identifiers and serial numbers, including license plate numbers 
x Device identifiers/serial numbers 
   Web addresses (URLs) 
   Internet IP addresses 
   Biometric identifiers, incl. finger and voice prints 
   Full face photographic images and any comparable images 
   Any other unique identifying number, characteristic, or code 
   None 

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Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classified as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity? 
No 
 
Tissue Specimens Obtained as Part of Research* 
Are Tissue Specimens being obtained for research? 
No 
 
Tissue Specimens - Collected during regular care* 
Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)? 
No 
 
Tissue Specimens - otherwise discarded* 
Would specimens otherwise be discarded? 
No 
 
Tissue Specimens - publicly available* 
Will tissue specimens be publicly available? 
No 
 
Tissue Specimens - Collected as part of research protocol* 
Will tissue specimens be collected as part of the research protocol? 
No 
 
Tissue Specimens - Banking of blood, tissue etc. for future use* 
Does research involve banking of blood, tissue, etc. for future use? 
No 
 
Genetic testing 
If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or 
exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision 
of genetic counseling. Describe how subject confidentiality will be protected Note: If no genetic testing 
is to be obtained, write: "Not applicable." 
Not applicable 
 
Consent 
 
1. Consent Process 
 
Overview 
Participant consent will be completed via the Way to Health Platform. Participants will be instructed to 
create a username and password through the WTH platform and then review and sign a brief consent 
allowing us to assess eligibility. Following this they will be screened with an eligibility survey presented 

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on the WTH platform. Once eligibility has been determined eligible participants will be instructed to 
review and sign the full consent for participation. Once complete they will be asked to complete the 
intake survey immediately. Questions will cover demographics, opinions, perceptions and experiences 
with alcohol consumption and driving. They will then continue on with their trial participation.  
 
If they are not eligible, the participant will be informed that they are ineligible for the current study and 
will not complete any study procedures.  
 
A member of the study team will then contact the participant to schedule an in person meeting or a 
phone meeting. If the participant completed consent in the hospital, they will move forward with the 
enrollment procedures or set up a time with a research team member to complete enrollment 
procedures at a later date and time over the phone. During this meeting the study team will answer any 
questions pertaining to the consent or the study. Participants will receive an email or a text message 
reminder regarding incomplete steps in WTH depending on their preference selection for 
communication. A member of the study team will contact all enrolled participants to ensure 
understanding of study procedures. Electronic signatures will be obtained. 
 
Children and Adolescents 
not applicable 
 
Adult Subjects Not Competent to Give Consent 
Participants will be excluded from the study if they are not competent to consent to the study. 
 
2. Waiver of Consent 
 
Waiver or Alteration of Informed Consent* 
Waiver of written documentation of informed consent: the only record linking the subject and the 
research would be the consent document and the principal risk would be potential harm resulting from 
a breach of confidentiality. 
 
Minimal Risk* 
Impact on Subject Rights and Welfare* 
Waiver Essential to Research* 
Additional Information to Subjects 
 
Written Statement of Research* 
Yes 
 
Risk / Benefit 
 
Potential Study Risks 
This is a minimal risk, behavioral intervention study. Physical risk is no more than the risks already 
caused by risky driving behavior. Participants will not have to interact with the TrueMotion app after 
installation and will be instructed to only use the BACtrack device in a safe setting. There are no 
expected serious adverse events related to the intervention or participation in this study. This program 
does not encourage drinking and driving, in fact, it is designed in hopes that participants will be more 

V4; 10.4.17 
informed about their level of intoxication and their ability to drive. Additionally, messages delivered 
following a positive BAC reading highlights the dangers and risks of a DUI. Attached to this protocol are 
examples of these messages.  
 
There is some risk that subjects will be identified as participants in the study and that the confidential 
information provided regarding psychiatric and substance use history will be inadvertently disclosed 
without the subjects permission. To help protect against this we will be using assigned participant IDs 
that will be tied to the data derived in this trial. These IDs will be used by our partners (TrueMotion and 
BACtrack) as the key identifier and data labeling. We will not disclose participants names as part of this 
trial.  
 
Rating Scales and Questionnaires. To avoid breach of confidentiality, subjects' names will appear only 
on a consent form, a telephone screening form and a "key" form kept in a locked cabinet. All forms that 
contain identifying information will be kept double locked (i.e., in a locked cabinet, in a locked room) to 
maintain their security. All study data forms will contain only the subject's unique study identification 
number, using a reference system maintained by the study staff. Completed study forms will be kept in a 
locked cabinet, the key to which will be available only to the PI and staff working on this study. Subject 
visits will be scheduled and no information about the subject will be provided to anyone (except in 
emergencies as defined above) in person or by telephone. All paper research records will be stored in 
locked cabinets and only the investigators and only IRB approved study will have access to those 
records. 
 
Potential Study Benefits 
All participants will benefit by receiving a text message to promote the use of a BAC monitor to help 
plan less risky driving incidents. Participants are contributing to preparation of a larger study, which in 
turn may have benefits to society in general. Understanding the potential of using breathalyzers to 
reduce risky drinking has the potential to benefit society in general. 
 
Alternatives to Participation (optional) 
 
Data and Safety Monitoring 
All source documents will be identified by study identification (ID) number, and the key to that ID 
number will be kept in a locked file cabinet. All personally identifiable information also will be kept 
separately in a locked file cabinet. No results will be reported in a personally identifiable manner. All 
tracking system data and research database information will be password-protected with several levels 
of protection: first, a password will be required to access the computer of the user who has access to 
the database; second, a password will be required to access the database. The principal investigator, Dr. 
Delgado, and the project manager, Jessie Hemmons, will monitor and maintain confidentiality of data. 
 
Risk / Benefit Assessment 
In general the benefits outweigh the risks in this study. Participants will receive information on alcohol 
consumption and health. Participants are also contributing to preparation of a larger study, which in 
turn may have benefits to society in general. Although there are some risks involved in participating in 
this study, as mentioned above, these can be minimized to ensure that the potential benefits exceed the 
potential risks, so that the risk/benefit ratio is favorable.