Trial Outcomes & Findings for Precision Vaccine Promotion in Underserved Populations (NCT NCT05537441)
NCT ID: NCT05537441
Last Updated: 2024-10-01
Results Overview
Number of Participants who received their influenza vaccination during the campaign period, as measured in the California Immunization Registry (CAIR2) to include vaccinations occurring both inside and outside the LADHS system. We assessed baseline vaccination status at the beginning of the flu season and excluded individuals who already received their vaccination.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
228831 participants
Primary outcome timeframe
6 months
Results posted on
2024-10-01
Participant Flow
Only one household member (index person) is randomized and all other members receive the same message
Participant milestones
| Measure |
Standard Texts
Patients randomized to this study arm will receive a standard text reminding them about the importance of influenza vaccination. The standard texts will include a clinic call back number and patient portal self-scheduling for patients to schedule their influenza vaccines:
#FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you.
Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.
|
Standard Texts With Transportation Messaging
Patients randomized to this study arm will receive standard texts plus transportation messaging including a phone number for patients to reserve transportation to a vaccination appointment based on MediCal health plan transportation resources:
#FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you. You can call #Health Plan Phone Number# to schedule a free ride for your flu shot through #HealthPlanName#.
Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.
|
|---|---|---|
|
Overall Study
STARTED
|
224959
|
3872
|
|
Overall Study
COMPLETED
|
224959
|
3872
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Precision Vaccine Promotion in Underserved Populations
Baseline characteristics by cohort
| Measure |
Standard Texts
n=121743 Participants
Patients randomized to this study arm will receive a standard text reminding them about the importance of influenza vaccination. The standard texts will include a clinic call back number and patient portal self-scheduling for patients to schedule their influenza vaccines:
#FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you.
Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.
|
Standard Texts With Transportation Messaging
n=3050 Participants
Patients randomized to this study arm will receive standard texts plus transportation messaging including a phone number for patients to reserve transportation to a vaccination appointment based on MediCal health plan transportation resources:
#FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you. You can call #Health Plan Phone Number# to schedule a free ride for your flu shot through #HealthPlanName#.
Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.
|
Total
n=124793 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.27 years
STANDARD_DEVIATION 19.68 • n=5 Participants
|
45.25 years
STANDARD_DEVIATION 19.78 • n=7 Participants
|
45.27 years
STANDARD_DEVIATION 19.68 • n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
62819 Participants
n=5 Participants
|
1595 Participants
n=7 Participants
|
64414 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
55271 Participants
n=5 Participants
|
1363 Participants
n=7 Participants
|
56634 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Unknown/Not reported
|
3653 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
3745 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
69637 Participants
n=5 Participants
|
1741 Participants
n=7 Participants
|
71378 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32141 Participants
n=5 Participants
|
776 Participants
n=7 Participants
|
32917 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19965 Participants
n=5 Participants
|
533 Participants
n=7 Participants
|
20498 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
121743 Participants
n=5 Participants
|
3050 Participants
n=7 Participants
|
124793 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: As not all randomized participants were eligible for the transportation messaging given their insurance did not cover healthcare transportation costs, these households were removed from both groups.
Number of Participants who received their influenza vaccination during the campaign period, as measured in the California Immunization Registry (CAIR2) to include vaccinations occurring both inside and outside the LADHS system. We assessed baseline vaccination status at the beginning of the flu season and excluded individuals who already received their vaccination.
Outcome measures
| Measure |
Standard Texts
n=121743 Participants
Patients randomized to this study arm will receive a standard text reminding them about the importance of influenza vaccination. The standard texts will include a clinic call back number and patient portal self-scheduling for patients to schedule their influenza vaccines:
#FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you.
Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.
|
Standard Texts With Transportation Messaging
n=3050 Participants
Patients randomized to this study arm will receive standard texts plus transportation messaging including a phone number for patients to reserve transportation to a vaccination appointment based on MediCal health plan transportation resources:
#FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you. You can call #Health Plan Phone Number# to schedule a free ride for your flu shot through #HealthPlanName#.
Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.
|
|---|---|---|
|
Number of Participants Vaccinated at the End of the Campaign Period
|
33357 Participants
|
854 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: As not all randomized participants were eligible for the transportation messaging given their insurance did not cover healthcare transportation costs, these households were removed from both groups.
Heterogeneity of treatment effects for demographic groups (previous vaccination status: vaccinated or unvaccinated)
Outcome measures
| Measure |
Standard Texts
n=121743 Participants
Patients randomized to this study arm will receive a standard text reminding them about the importance of influenza vaccination. The standard texts will include a clinic call back number and patient portal self-scheduling for patients to schedule their influenza vaccines:
#FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you.
Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.
|
Standard Texts With Transportation Messaging
n=3050 Participants
Patients randomized to this study arm will receive standard texts plus transportation messaging including a phone number for patients to reserve transportation to a vaccination appointment based on MediCal health plan transportation resources:
#FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you. You can call #Health Plan Phone Number# to schedule a free ride for your flu shot through #HealthPlanName#.
Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.
|
|---|---|---|
|
Heterogeneity of Treatment Effects for Demographics
Previously vaccinated
|
44742 Participants
|
1129 Participants
|
|
Heterogeneity of Treatment Effects for Demographics
Previously unvaccinated
|
77001 Participants
|
1921 Participants
|
Adverse Events
Standard Texts
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Texts With Transportation Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place