Risk Reduction
Conditions
Keywords
text message, behavioral intervention, motor vehicle
Brief summary
The Safe Vehicle Engagement (SaVE) trials are 3 parallel randomized clinical trials that aim to determine the impact of text messaging (SMS) vehicle safety interventions vs. weekly SMS vehicle safety self-monitoring alone on seat belt use, distracted driving and drink driving among young adults identified in the emergency department (ED) with risky vehicle behaviors.
Detailed description
The investigators propose to conduct 3 related randomized, controlled, parallel group, assessor-blind, superiority trials of 6-week text message interventions vs. SMS vehicle safety self-monitoring in young adult participants with risky vehicle behaviors. A total of 500 adult participants will be enrolled: 300 into Cohort 1 (seat belt); 100 into Cohort 2 (distracted driving); 100 into Cohort 3 (drink driving). Each SMS intervention will be designed to target a single risk behavior. The study is powered to show a difference of 15% in the percentage of subjects reporting seat belt use at week 8. Other cohort trials (i.e. distracted driving, drink driving) and outcomes will be exploratory.
Interventions
BEHAVIORALSMS Dialogue
Once-weekly SMS dialogue sessions or micro-interventions and use behavior change techniques (BCTs) including self-monitoring with performance feedback and goal support
BEHAVIORALSMS Assessments
Once-weekly SMS assessments of motor vehicle risks
Sponsors
University of Pennsylvania
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective, randomized, 2-arm (intervention vs. control)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1\) Adult participant (age ≥ 18 years & ≤25 years) 1. Cohort 1: Any vehicle trip in past 2 weeks where individual reports not using a seat belt 2. Cohort 2: Any vehicle trip in past 2 weeks where individual reports phone was used to type while driving and car was moving 3. Cohort 3: Any vehicle trip in past 2 weeks where individual reports driving a vehicle within 2 hours after consuming 2 or more drinks
Exclusion criteria
1. Member of a protected population (prisoner) 2. Unable to provide informed consent 3. No plan to drive and/or ride in a vehicle in the next month 4. Non-English speaking 5. No personal mobile phone or planning on changing phone in next 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seat Belt Use | Week 8 | Participant count reporting always using a seat belt over past 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment | Baseline | Percentage of ED patients who screen positive |
| Measure of Intervention Acceptability | 2 weeks to 8 weeks | Percentage of ED patients enrolled in the Intervention arm who complete at least 50% of the SMS assessments during the intervention period |
| Seat Belt Use | Week 14 | Participant count reporting always using a seat belt over past 2 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SMS Intervention Once-weekly automated SMS dialogue sessions or micro-interventions and use behavior change techniques including self-monitoring with performance feedback and goal support
SMS Dialogue: Once-weekly SMS dialogue sessions or micro-interventions and use behavior change techniques (BCTs) including self-monitoring with performance feedback and goal support | 110 |
| SMS Assessments Once-weekly SMS assessments related to their target risk behavior without receiving any feedback or goal support
SMS Assessments: Once-weekly SMS assessments of motor vehicle risks | 108 |
| Total | 218 |
Baseline characteristics
| Characteristic | SMS Assessments | Total | SMS Intervention |
|---|---|---|---|
| Age, Continuous | 21.6 years STANDARD_DEVIATION 2 | 21.5 years STANDARD_DEVIATION 2.1 | 21.5 years STANDARD_DEVIATION 2.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 72 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 13 Participants | 10 Participants |
| Race (NIH/OMB) White | 60 Participants | 111 Participants | 51 Participants |
| Sex: Female, Male Female | 71 Participants | 139 Participants | 68 Participants |
| Sex: Female, Male Male | 37 Participants | 79 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 108 |
| other Total, other adverse events | 0 / 110 | 0 / 108 |
| serious Total, serious adverse events | 0 / 110 | 0 / 108 |
Outcome results
Primary
Seat Belt Use
Participant count reporting always using a seat belt over past 2 weeks
Time frame: Week 8
Population: 158 participants completed the 8-week follow-up and thus were included in outcome analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMS Intervention | Seat Belt Use | 34 Participants |
| SMS Assessments | Seat Belt Use | 15 Participants |
Secondary
Feasibility of Recruitment
Percentage of ED patients who screen positive
Time frame: Baseline
Population: Reported less than always seat belt use in the past 2 weeks either as a driver or passenger and met other enrollment criteria
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMS Intervention | Feasibility of Recruitment | 218 Participants |
Secondary
Measure of Intervention Acceptability
Percentage of ED patients enrolled in the Intervention arm who complete at least 50% of the SMS assessments during the intervention period
Time frame: 2 weeks to 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMS Intervention | Measure of Intervention Acceptability | 56 Participants |
| SMS Assessments | Measure of Intervention Acceptability | 59 Participants |
Secondary
Seat Belt Use
Participant count reporting always using a seat belt over past 2 weeks
Time frame: Week 14
Population: 140 participants completed the 14-week follow-up and thus were included in outcome analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMS Intervention | Seat Belt Use | 32 Participants |
| SMS Assessments | Seat Belt Use | 20 Participants |