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Automobile AccidentNCT05298267

Reducing Distracted Driving With the Flip of a Switch

A study testing Do Not Disturb While Driving in people with Automobile Accident, run by University of Pennsylvania.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

We propose to test a potential intervention to reduce distracted driving among high school students that could be used as part of future research trials and school campaigns. This intervention is designed to encourage use of a setting that silences incoming calls and messages while the person is driving. Read more about this study

Who is it for?
Ages 16 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Automobile Accident
What is being tested?
Do Not Disturb While Driving
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 Mar 2022to 31 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • High School student with school assigned email address
  • Has a cell phone with ability to download Way to Drive app
  • Has a driver's license and typically drives every week

Who cannot join

  • Unable to read or understand English
  • Under 18 years old and no parental consent

About this study

We propose to test a potential intervention to reduce distracted driving among high school students that could be used as part of future research trials and school campaigns. This intervention is designed to encourage use of a setting that silences incoming calls and messages while the person is driving.

Read the detailed description

The purpose of this study is to test an intervention to reduce distracted driving among high school students. We're interested in learning the use of Do Not Disturb While Driving (DNDWD) by high school students. Participants will be recruited to participate into a 4-week study. Those that consent will download a driving app that will monitor their phone use while driving. Halfway through the monitoring period, we will ask participants to turn on DNDWD. Participants will also have the opportunity to enroll into an auto-reply message contest for best message. Once the 4- week monitoring period is complete participants will complete and exit survey

Being tested
Do Not Disturb While Driving
Keywords
distracted driving automobile, behavioral economics (nudge), smartphone application

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Do Not Disturb While DrivingDevice

    Participants will be asked to turn on Do Not Disturb While Driving on their smartphones.

Study groups in NCT05298267
Study groupRoleWhat they receive
Monitoring phaseExperimentalParticipants will be monitored for 4 weeks. Halfway through the monitoring period, participants will be asked to turn on DNDWD.
Receives: Device: Do Not Disturb While Driving

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in self-reported DNDWD

    Change is reported use. Dichotomy of use or non-use pre and post intervention

    Measured: For the duration of the study; 4 weeks

Secondary outcomes (10)

  1. Seconds of active (handheld) phone use per hour of driving

    This is a composite outcome that measures the proportion of total trip time in which the driver is engaged in handheld phone call use or non-call handheld use (e.g. texting, swiping, and typing), as measured by the Way to Drive app. Several studies (e.g. Klauer, NEJM, 2014) have demonstrated the association between handheld phone use (e.g., reaching for phone, typing, swiping, dialing) and increased crash risk. This outcome is also known as the active phone use percentage. Passive phone use (e.g. phone is streaming GPS navigation directions or music without any typing, swiping, and handheld holding of the phone) is not included in this outcome. Trips are only counted if the app predicts the user was a driver for the trip based on the phone sensor data and the user does not correct the app; or, if the user corrects the app and indicates they were driving.

    Measured: For the duration of the study; 4 weeks

  2. Seconds of active (handheld) call use per hour of driving.

    We will analyze the components of the secondary outcome separately.

    Measured: For the duration of the study; 4 weeks

  3. Seconds of active (handheld) non-call use per hour of driving

    We will analyze the components of the secondary outcome separately.

    Measured: For the duration of the study; 4 weeks

  4. Seconds of passive (hands-free) call use per hour of driving

    Use of DNDWD should also cut down on hands-free driving distraction.

    Measured: For the duration of the study; 4 weeks

  5. Seconds of passive (hands-free) non-call use per hour of driving.

    Use of DNDWD should also cut down on hands-free driving distraction.

    Measured: For the duration of the study; 4 weeks

  6. Seconds of speeding per hour of driving

    . Speeding events, defined as >10 mph above the posted speed limit, are detected by the app.

    Measured: For the duration of the study; 4 weeks

  7. Hard braking events per 100 miles.

    Hard braking events are detected by the app.

    Measured: For the duration of the study; 4 weeks

  8. Fast acceleration events per 100 miles.

    Fast acceleration events are detected by the app.

    Acceptability of interventions will be measured using a mixed-methods approach:

    Measured: For the duration of the study; 4 weeks

  9. Net promoter score

    In the exit survey, participants will be asked "How likely is it that you would recommend this program to a friend or colleague?" on a 0 to 10 scale.

    Measured: For the duration of the study; 4 weeks

  10. Responses to open-ended questions in exit survey

    Participants will be asked the following two open-ended questions: 1) "Please tell us what you liked about participating in this study;" 2) "Please tell us what you didn't like about participating in this study and how we should improve the experience in the future." These qualitative responses will be coded for content related to intervention acceptability and emerging themes will be identified.

    Measured: For the duration of the study; 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study start31 Mar 2022
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Why it stopped: withdrawn prior to study launch because a research partnership with the school district could not be secured in time

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Participants will be monitored for 4 weeks. Halfway through the monitoring period, participants will be asked to turn on the DNDWD feature on their phone.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05298267
Sponsor's protocol ID
851002
Status last verified
Apr 2022
First submitted
17 Mar 2022
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Asch DA, Rosin R. Engineering Social Incentives for Health. N Engl J Med. 2016 Dec 29;375(26):2511-3. doi: 10.1056/NEJMp1603978. No abstract available.

    PubMed 28029924

  • AT&T. AT&T Teen Driver Survey: Executive Summary 2012. https://www.att.com/Common/aboutus/txtingdriving/attteensurveyexecutive.pdf

  • Delgado MK, Wanner KJ, McDonald C. Adolescent Cellphone Use While Driving: An Overview of the Literature and Promising Future Directions for Prevention. Media Commun. 2016 Jun 16;4(3):79-89. doi: 10.17645/mac.v4i3.536.

    PubMed 27695663

  • Department of Transportation, NHTSA. Visual-Manual NHTSA Driver Distraction Guidelines for Portable and Aftermarket Devices. 2016. Docket No. NHTSA-2013-0137. Available at: https://www.nhtsa.gov/press-releases/us-dot-proposes-guidelines- address-driver-distraction-caused-mobile-devices-vehicles.

  • Creaser JI, Edwards CJ, Morris NL, Donath M. Are cellular phone blocking applications effective for novice teen drivers? J Safety Res. 2015 Sep;54:75-8. doi: 10.1016/j.jsr.2015.06.014. Epub 2015 Jul 29.

    PubMed 26403905

  • Ebel B, Boyle L, O'Connor S, et al. Randomized Trial of Cell Phone Blocking and In-Vehicle Camera To Reduce High-Risk Driving Events among Novice Drivers. San Diego, CA: Pediatric Academic Societies; 2015.

  • Funkhouser D, Sayer JR. Cellphone Filter/Blocker Techonology Field Test. Washington, DC: NHTSA; 2013. Report No. HS 811 863.

  • Hayashi Y, Russo CT, Wirth O. Texting while driving as impulsive choice: A behavioral economic analysis. Accid Anal Prev. 2015 Oct;83:182-9. doi: 10.1016/j.aap.2015.07.025. Epub 2015 Aug 13.

    PubMed 26280804

  • Holm S. A simple sequentially rejective multiple test procedure. Scandinavian J. of Statistics 1979 6:65-70.

  • Kervick AA, Hogan MJ, O'Hora D, Sarma KM. Testing a structural model of young driver willingness to uptake Smartphone Driver Support Systems. Accid Anal Prev. 2015 Oct;83:171-81. doi: 10.1016/j.aap.2015.07.023. Epub 2015 Aug 13.

    PubMed 26277411

  • Kolko, Jed. "How Suburban Are Big American Cities?" FiveThirtyEight, 15 May 2015, fivethirtyeight.com/features/how-suburban-are-big-american-cities/.

  • Klauer SG, Guo F, Simons-Morton BG, Ouimet MC, Lee SE, Dingus TA. Distracted driving and risk of road crashes among novice and experienced drivers. N Engl J Med. 2014 Jan 2;370(1):54-9. doi: 10.1056/NEJMsa1204142.

    PubMed 24382065

  • Loewenstein G, Asch DA, Volpp KG. Behavioral economics holds potential to deliver better results for patients, insurers, and employers. Health Aff (Millwood). 2013 Jul;32(7):1244-50. doi: 10.1377/hlthaff.2012.1163.

    PubMed 23836740

  • Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. doi: 10.1001/jama.298.20.2415. No abstract available.

    PubMed 18042920

  • Musicant O, Lotan T. Can novice drivers be motivated to use a smartphone based app that monitors their behavior? Transp Res Part F Traffic Psy- chol Behav. 2016;42:544-557.

Questions about this trial

What is this clinical trial studying?

A study testing Do Not Disturb While Driving in people with Automobile Accident, run by University of Pennsylvania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in self-reported DNDWD (time frame: For the duration of the study; 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05298267, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.

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