<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03833219</url>
  </required_header>
  <id_info>
    <org_study_id>693JJ31750012</org_study_id>
    <nct_id>NCT03833219</nct_id>
  </id_info>
  <brief_title>Comparative Effectiveness of Financial Incentives and Nudges to Reduce Cellphone Use While Driving Among UBI Auto Policy Holders</brief_title>
  <official_title>Comparative Effectiveness of Financial Incentives and Smartphone-based Nudges to Reduce Cellphone Use While Driving Among Auto Insurance Policy Holders With Usage Based Insurance Policies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Department of Transportation Federal Highway Administration</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are proposing an experiment to help a national auto insurance company test&#xD;
      behavioral economic strategies to reduce the amount of time policy holders actively use their&#xD;
      cell phone while driving. Interventions include financial incentives, social comparison, and&#xD;
      nudges, and survey data will also be collected. Data collected from this internal trial will&#xD;
      be shared with the Penn research team and analyzed&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2019</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seconds of active phone use per hour of driving</measure>
    <time_frame>150 days</time_frame>
    <description>Percentage of driving time engaging in active handheld phone use (also measured as seconds of distracted driving/hour of driving)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seconds of passive phone use per hour of driving</measure>
    <time_frame>150 days</time_frame>
    <description>Seconds of passive handheld, non-call use per hour of driving</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hard breaking events per 100 miles</measure>
    <time_frame>150 days</time_frame>
    <description>notifications turned off, drop out of study, app uninstall</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hard acceleration events per 100 miles</measure>
    <time_frame>150 days</time_frame>
    <description>Hard acceleration events per 100 miles</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">2108</enrollment>
  <condition>Automobile Accident</condition>
  <arm_group>
    <arm_group_label>Control (monitor only)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Continue in monitoring only mode</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social comparison feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Report user's handheld phone use/ hour of driving for week. Compare this week's performance to distribution for driver cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>End of rating period incentive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monitor throughout intervention period and compare overall use to distribution for cohort. Notify participant at end of intervention period regarding the amount they have earned.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>End of rating period incentive + social comparison feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monitor throughout intervention period and compare weekly phone use to driver cohort distribution. Send weekly push notification to provide feedback. Notify participant at end of intervention period regarding the amount they have earned.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weekly loss-framed incentive + social comparison feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monitor throughout intervention period and compare weekly phone use to driver cohort distribution. Send weekly push notification to provide feedback. Notify participant weekly regarding the amount they have earned.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Larger weekly loss-framed incentive+social comparison feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monitor throughout intervention period and compare weekly phone use to driver cohort distribution. Send weekly push notification to provide feedback. Notify participant weekly regarding the amount they have earned. Incentive amount is higher than &quot;Weekly loss-framed incentive + social comparison feedback&quot; Arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weekly feedback</intervention_name>
    <description>Send push notification reporting user's handheld phone use while driving compared to distribution for driver cohort (age, geographic area) each week.</description>
    <arm_group_label>End of rating period incentive + social comparison feedback</arm_group_label>
    <arm_group_label>Larger weekly loss-framed incentive+social comparison feedback</arm_group_label>
    <arm_group_label>Social comparison feedback</arm_group_label>
    <arm_group_label>Weekly loss-framed incentive + social comparison feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>End of intervention period incentive</intervention_name>
    <description>Notify participant about potential incentive at the end of the intervention period, but do not provide weekly feedback about performance.</description>
    <arm_group_label>End of rating period incentive</arm_group_label>
    <arm_group_label>End of rating period incentive + social comparison feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Loss-framed weekly incentive</intervention_name>
    <description>Send push notification reporting user's handheld phone use while driving compared to distribution for driver cohort (age, geographic area) each week. Pay participant weekly according to where they fall on the distribution each week.</description>
    <arm_group_label>Larger weekly loss-framed incentive+social comparison feedback</arm_group_label>
    <arm_group_label>Weekly loss-framed incentive + social comparison feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Progressive Snapshot Users with policy activated within recruitment period&#xD;
&#xD;
          -  Progressive Snapshot policy holder in one of the following states and regions: MI, PA,&#xD;
             TX, FL, TN, OR, GA, NE, OK, OH, MT, MO, NV, CT, WI, MD, KY, MN, NH, NJ, AZ, ME, LA,&#xD;
             SC, CO, MS, IN, IA, AL, ND, UT, RI, WV, WY, IL, AR, DE, KS, SD, NM, VT, ID, and the&#xD;
             District of Columbia&#xD;
&#xD;
          -  Has an email address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Progressive Snapshot Mobile App not updated to enable push notifications&#xD;
&#xD;
          -  Customer's residential address is in a state in which phone use while driving is&#xD;
             factored into insurance rating&#xD;
&#xD;
          -  Customer's Snapshot Mobile App does not collect trip data with all sensors active&#xD;
&#xD;
          -  Customer in Snapshot program for &lt; 30 days or more &gt; 70 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>M. Kit Delgado, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.naic.org/cipr_topics/topic_usage_based_insurance.htm</url>
    <description>Center for Insurance Policy Research. Usage-Based Insurance and Telematics. National Association of Insurance Commissioners.</description>
  </link>
  <link>
    <url>http://teendriving.statefarm.com/road-to-safety/risky-driving/distracted-driving</url>
    <description>State Farm. (2014). Distracted Driving</description>
  </link>
  <link>
    <url>http://nyti.ms/2cuPDU6</url>
    <description>Richtel, M. Phone Makers Could Cut Off Drivers. So Why Don't They? New York Times. September 2016.</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>27695663</PMID>
  </reference>
  <reference>
    <citation>French B, Small DS, Novak J, Saulsgiver KA, Harhay MO, Asch DA, Volpp KG, Halpern SD. Preference-adaptive randomization in comparative effectiveness studies. Trials. 2015 Mar 18;16:99. doi: 10.1186/s13063-015-0592-6.</citation>
    <PMID>25887045</PMID>
  </reference>
  <reference>
    <citation>Halpern SD, Ubel PA, Asch DA. Harnessing the power of default options to improve health care. N Engl J Med. 2007 Sep 27;357(13):1340-4. doi: 10.1056/NEJMsb071595. No abstract available.</citation>
    <PMID>17898105</PMID>
  </reference>
  <reference>
    <citation>Halpern SD, French B, Small DS, Saulsgiver K, Harhay MO, Audrain-McGovern J, Loewenstein G, Brennan TA, Asch DA, Volpp KG. Randomized trial of four financial-incentive programs for smoking cessation. N Engl J Med. 2015 May 28;372(22):2108-17. doi: 10.1056/NEJMoa1414293. Epub 2015 May 13.</citation>
    <PMID>25970009</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26280804</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24382065</PMID>
  </reference>
  <reference>
    <citation>Lahrmann H, Agerholm N, Tradisauskas N, Berthelsen KK, Harms L. Pay as You Speed, ISA with incentive for not speeding: results and interpretation of speed data. Accid Anal Prev. 2012 Sep;48:17-28. doi: 10.1016/j.aap.2011.03.015. Epub 2011 Apr 9.</citation>
    <PMID>22664664</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18042920</PMID>
  </reference>
  <reference>
    <citation>Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Eberbach K, Walters KJ, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Individual Versus Team-Based Financial Incentives to Increase Physical Activity: A Randomized, Controlled Trial. J Gen Intern Med. 2016 Jul;31(7):746-54. doi: 10.1007/s11606-016-3627-0. Epub 2016 Mar 14.</citation>
    <PMID>26976287</PMID>
  </reference>
  <reference>
    <citation>Reagan IJ, Bliss JP, Van Houten R, Hilton BW. The effects of external motivation and real-time automated feedback on speeding behavior in a naturalistic setting. Hum Factors. 2013 Feb;55(1):218-30. doi: 10.1177/0018720812447812.</citation>
    <PMID>23516803</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 7, 2018</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>distracted driving automobile</keyword>
  <keyword>behavioral economics</keyword>
  <keyword>usage-based insurance</keyword>
  <keyword>auto insurance</keyword>
  <keyword>automobile</keyword>
  <keyword>smartphone application</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>PI will not own individual participant data</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03833219/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03833219
org study id: 693JJ31750012
nct id: NCT03833219
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators are proposing an experiment to help a national auto insurance company test
      behavioral economic strategies to reduce the amount of time policy holders actively use their
      cell phone while driving. Interventions include financial incentives, social comparison, and
      nudges, and survey data will also be collected. Data collected from this internal trial will
      be shared with the Penn research team and analyzed
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Seconds of active phone use per hour of driving
time frame: 150 days
description: Percentage of driving time engaging in active handheld phone use (also measured as seconds of distracted driving/hour of driving)
measure: Seconds of passive phone use per hour of driving
time frame: 150 days
description: Seconds of passive handheld, non-call use per hour of driving
measure: Hard breaking events per 100 miles
time frame: 150 days
description: notifications turned off, drop out of study, app uninstall
measure: Hard acceleration events per 100 miles
time frame: 150 days
description: Hard acceleration events per 100 miles
arm group label: Control (monitor only)
arm group type: No Intervention
description: Continue in monitoring only mode
arm group label: Social comparison feedback
arm group type: Experimental
description: Report user's handheld phone use/ hour of driving for week. Compare this week's performance to distribution for driver cohort.
arm group label: End of rating period incentive
arm group type: Experimental
description: Monitor throughout intervention period and compare overall use to distribution for cohort. Notify participant at end of intervention period regarding the amount they have earned.
arm group label: End of rating period incentive + social comparison feedback
arm group type: Experimental
description: Monitor throughout intervention period and compare weekly phone use to driver cohort distribution. Send weekly push notification to provide feedback. Notify participant at end of intervention period regarding the amount they have earned.
arm group label: Weekly loss-framed incentive + social comparison feedback
arm group type: Experimental
description: Monitor throughout intervention period and compare weekly phone use to driver cohort distribution. Send weekly push notification to provide feedback. Notify participant weekly regarding the amount they have earned.
arm group label: Larger weekly loss-framed incentive+social comparison feedback
arm group type: Experimental
description: Monitor throughout intervention period and compare weekly phone use to driver cohort distribution. Send weekly push notification to provide feedback. Notify participant weekly regarding the amount they have earned. Incentive amount is higher than "Weekly loss-framed incentive + social comparison feedback" Arm.
intervention type: Behavioral
intervention name: Weekly feedback
description: Send push notification reporting user's handheld phone use while driving compared to distribution for driver cohort (age, geographic area) each week.
arm group label: End of rating period incentive + social comparison feedback
arm group label: Larger weekly loss-framed incentive+social comparison feedback
arm group label: Social comparison feedback
arm group label: Weekly loss-framed incentive + social comparison feedback
intervention type: Behavioral
intervention name: End of intervention period incentive
description: Notify participant about potential incentive at the end of the intervention period, but do not provide weekly feedback about performance.
arm group label: End of rating period incentive
arm group label: End of rating period incentive + social comparison feedback
intervention type: Behavioral
intervention name: Loss-framed weekly incentive
description: Send push notification reporting user's handheld phone use while driving compared to distribution for driver cohort (age, geographic area) each week. Pay participant weekly according to where they fall on the distribution each week.
arm group label: Larger weekly loss-framed incentive+social comparison feedback
arm group label: Weekly loss-framed incentive + social comparison feedback
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: M. Kit Delgado, MD, MS
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
url: http://www.naic.org/cipr_topics/topic_usage_based_insurance.htm
description: Center for Insurance Policy Research. Usage-Based Insurance and Telematics. National Association of Insurance Commissioners.
url: http://teendriving.statefarm.com/road-to-safety/risky-driving/distracted-driving
description: State Farm. (2014). Distracted Driving
url: http://nyti.ms/2cuPDU6
description: Richtel, M. Phone Makers Could Cut Off Drivers. So Why Don't They? New York Times. September 2016.
citation: 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.
PMID: 27695663
citation: French B, Small DS, Novak J, Saulsgiver KA, Harhay MO, Asch DA, Volpp KG, Halpern SD. Preference-adaptive randomization in comparative effectiveness studies. Trials. 2015 Mar 18;16:99. doi: 10.1186/s13063-015-0592-6.
PMID: 25887045
citation: Halpern SD, Ubel PA, Asch DA. Harnessing the power of default options to improve health care. N Engl J Med. 2007 Sep 27;357(13):1340-4. doi: 10.1056/NEJMsb071595. No abstract available.
PMID: 17898105
citation: Halpern SD, French B, Small DS, Saulsgiver K, Harhay MO, Audrain-McGovern J, Loewenstein G, Brennan TA, Asch DA, Volpp KG. Randomized trial of four financial-incentive programs for smoking cessation. N Engl J Med. 2015 May 28;372(22):2108-17. doi: 10.1056/NEJMoa1414293. Epub 2015 May 13.
PMID: 25970009
citation: 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.
PMID: 26280804
citation: 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.
PMID: 24382065
citation: Lahrmann H, Agerholm N, Tradisauskas N, Berthelsen KK, Harms L. Pay as You Speed, ISA with incentive for not speeding: results and interpretation of speed data. Accid Anal Prev. 2012 Sep;48:17-28. doi: 10.1016/j.aap.2011.03.015. Epub 2011 Apr 9.
PMID: 22664664
citation: 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.
PMID: 18042920
citation: Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Eberbach K, Walters KJ, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Individual Versus Team-Based Financial Incentives to Increase Physical Activity: A Randomized, Controlled Trial. J Gen Intern Med. 2016 Jul;31(7):746-54. doi: 10.1007/s11606-016-3627-0. Epub 2016 Mar 14.
PMID: 26976287
citation: Reagan IJ, Bliss JP, Van Houten R, Hilton BW. The effects of external motivation and real-time automated feedback on speeding behavior in a naturalistic setting. Hum Factors. 2013 Feb;55(1):218-30. doi: 10.1177/0018720812447812.
PMID: 23516803
responsible party type: Sponsor
sharing ipd: No
ipd description: PI will not own individual participant data
provided document: 