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Text Reminders to Immunize in a Managed Care Organization (TRIO)

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ClinicalTrials.gov Identifier: NCT01806714
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Cynthia Rand, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Health Services Research
Condition Human Papilloma Virus
Interventions Other: Text-based reminder for recommended HPV vaccine or WCC
Other: Non-specific text-based reminder (general health tip)
Enrollment 3812
Recruitment Details 4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers
Pre-assignment Details For this study, there was a waiver of consent; 4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers.
Arm/Group Title Text-based Reminder for HPV Vaccine/WCC Control Arm
Hide Arm/Group Description

Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit

Text-based reminder for recommended HPV vaccine or well care visit

Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Period Title: Overall Study
Started 2093 2089
Completed 1893 1919
Not Completed 200 170
Reason Not Completed
No functioning phone number             200             170
Arm/Group Title Text-based Reminder for HPV Vaccine/WCC Control Arm Total
Hide Arm/Group Description

Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit

Text-based reminder for recommended HPV vaccine or well care visit

Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Total of all reporting groups
Overall Number of Baseline Participants 1893 1919 3812
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1893 participants 1919 participants 3812 participants
11 year olds 428 407 835
12 year olds 341 380 721
13 year olds 307 324 631
14 year olds 281 288 569
15 year olds 271 270 541
16 year olds 265 250 515
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1893 participants 1919 participants 3812 participants
Female
863
  45.6%
868
  45.2%
1731
  45.4%
Male
1030
  54.4%
1051
  54.8%
2081
  54.6%
1.Primary Outcome
Title Percentage of Participants Receiving HPV Vaccination (Dose 1)
Hide Description Participants who received HPV vaccine dose 1 Kaplan-Meier failure function
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid phone numbers at the time dose 1 was dispensed received dose 1.
Arm/Group Title Text-based Reminder for HPV Vaccine/WCC Control Arm
Hide Arm/Group Description:

Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit

Text-based reminder for recommended HPV vaccine or well care visit

Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Overall Number of Participants Analyzed 964 961
Measure Type: Number
Unit of Measure: percentage of eligible participants
16 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Text-based Reminder for HPV Vaccine/WCC, Control Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.04
Comments [Not Specified]
Method clustered stratified Proportional Hazard
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
1.0 to 1.6
Estimation Comments We determined hazard ratios using a clustered stratified Cox model with the Efron method to handle tied events and the Huber/White variance estimator that clustered on primary care provider and stratified on practice.
2.Secondary Outcome
Title Percentage of Participants Receiving HPV Vaccination (Dose 2)
Hide Description Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects with a valid phone number at the time dose 2 was dispensed received the vaccine. The number of subjects receiving dose 2 is higher than dose 1 because some phones numbers that were inactive during dose 1 were active during dose 2.
Arm/Group Title Text-based Reminder for HPV Vaccine/WCC Control Arm
Hide Arm/Group Description:

Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit

Text-based reminder for recommended HPV vaccine or well care visit

Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Overall Number of Participants Analyzed 1007 1014
Measure Type: Number
Unit of Measure: percentage of eligible participants
6 7
3.Secondary Outcome
Title Percentage of Participants Receiving HPV Vaccination (Dose 3)
Hide Description Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid phone numbers were included and not all recipients got the 2nd dose. Only subjects who got the 2nd dose were then given the 3rd dose and only if they had working phone numbers.
Arm/Group Title Text-based Reminder for HPV Vaccine/WCC Control Arm
Hide Arm/Group Description:

Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit

Text-based reminder for recommended HPV vaccine or well care visit

Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Overall Number of Participants Analyzed 958 966
Measure Type: Number
Unit of Measure: percentage of eligible participants
2 2
Time Frame July 2013 - December 2014
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Text-based Reminder for HPV Vaccine/WCC Control Arm
Hide Arm/Group Description

Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit

Text-based reminder for recommended HPV vaccine or well care visit

Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

All-Cause Mortality
Text-based Reminder for HPV Vaccine/WCC Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Text-based Reminder for HPV Vaccine/WCC Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1893 (0.00%)   0/1919 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Text-based Reminder for HPV Vaccine/WCC Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1893 (0.00%)   0/1919 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Cynthia Rand
Organization: University of Rochester
Phone: 585 275-9316
Responsible Party: Cynthia Rand, University of Rochester
ClinicalTrials.gov Identifier: NCT01806714     History of Changes
Other Study ID Numbers: 056103-002
First Submitted: March 5, 2013
First Posted: March 7, 2013
Results First Submitted: December 30, 2015
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017