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Text Reminders to Immunize in a Managed Care Organization

Text Reminders to Immunize in a Managed Care Organization

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01806714
Acronym
TRIO
Enrollment
3812
Registered
2013-03-07
Start date
2013-07-31
Completion date
2014-12-31
Last updated
2017-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus

Keywords

HPV vaccination, Adolescent well care, Adolescent HPV immunization, HPV

Brief summary

The purpose of the study is to evaluate the effectiveness of a managed care-based HPV vaccination reminder/recall system using a randomized controlled trial (RCT) across diverse practices and patient populations. The trial will measure the effectiveness of text messaging reminder/recall on (a) improving initiation and (b) completion rate of the HPV vaccine series; (c) decreasing the time between vaccine doses; and (d) improving rates of preventive visits for adolescents The hypotheses are that text-messaged reminders to parents of adolescents will result in improved rates of HPV vaccine series initiation, HPV vaccine series completion, will decrease the intervals between vaccine doses and will improve rates of preventive care among adolescents. Parents receiving specific text-messaged reminders about services (i.e. HPV vaccination, well child care visits) for which their adolescent is due will be compared to a control group of parents receiving general health tips through text messages.

Detailed description

The study setting is western New York State and the Southern Tier of New York State (15 counties total). Investigators will work with the Monroe Plan for Medical Care, an IPA-model managed care organization (MCO) that serves Medicaid managed care and SCHIP enrollees. The MCO will conduct regular reviews of insurance claims data and the New York State Immunization Information System of adolescents ages 11-\<16 years. Parents (all over 18 years of age) of adolescents will receive the texted messages on their phones. There are no enrollment restrictions based upon race or ethnic origin. The inclusion criteria are that the adolescents are a) enrolled in Medicaid or SCHIP through the Monroe Plan, b) have been enrolled greater than 6 months with the Monroe Plan (in order to have sufficient claims data to determine whether they are due for a well child care visit or recommended immunizations), c) the Monroe Plan has received their consent to send preventive care text messages, d) their child attend a primary care practice that has agreed to participate and d) they are between the ages of 11-\<16 years at the start of the study. The key independent measure is group allocation (intervention vs. control); an intention-to-treat strategy will be used to assess the effectiveness of text messaging reminders. Key outcome measures will be: 1) receipt of 0, 1, 2 or 3 doses of HPV vaccine 2) interval (in days) between doses and 3) having a preventive visit in the 6 month period.

Interventions

OTHERNon-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)

OTHERText-based reminder for recommended HPV vaccine or WCC

Patients due for a well visit or HPV vaccine received a text reminder

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* 11-\<18 years * Member of MCO for \>6 months * Opted in to receive texted reminders from MCO

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Receiving HPV Vaccination (Dose 1)9 monthsParticipants who received HPV vaccine dose 1 Kaplan-Meier failure function

Secondary

MeasureTime frameDescription
Percentage of Participants Receiving HPV Vaccination (Dose 2)9 monthsParticipants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function
Percentage of Participants Receiving HPV Vaccination (Dose 3)9 monthsParticipants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function

Countries

United States

Participant flow

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.

Participants by arm

ArmCount
Text-based Reminder for HPV Vaccine/WCC
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
1,893
Control Arm
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)
1,919
Total3,812

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyNo functioning phone number200170

Baseline characteristics

CharacteristicText-based Reminder for HPV Vaccine/WCCControl ArmTotal
Age, Customized
11 year olds
428 participants407 participants835 participants
Age, Customized
12 year olds
341 participants380 participants721 participants
Age, Customized
13 year olds
307 participants324 participants631 participants
Age, Customized
14 year olds
281 participants288 participants569 participants
Age, Customized
15 year olds
271 participants270 participants541 participants
Age, Customized
16 year olds
265 participants250 participants515 participants
Sex: Female, Male
Female
863 Participants868 Participants1731 Participants
Sex: Female, Male
Male
1030 Participants1051 Participants2081 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1,8930 / 1,919
serious
Total, serious adverse events
0 / 1,8930 / 1,919

Outcome results

Primary

Percentage of Participants Receiving HPV Vaccination (Dose 1)

Participants who received HPV vaccine dose 1 Kaplan-Meier failure function

Time frame: 9 months

Population: Only subjects with valid phone numbers at the time dose 1 was dispensed received dose 1.

ArmMeasureValue (NUMBER)
Text-based Reminder for HPV Vaccine/WCCPercentage of Participants Receiving HPV Vaccination (Dose 1)16 percentage of eligible participants
Control ArmPercentage of Participants Receiving HPV Vaccination (Dose 1)13 percentage of eligible participants
p-value: <0.0495% CI: [1, 1.6]clustered stratified Proportional Hazard
Secondary

Percentage of Participants Receiving HPV Vaccination (Dose 2)

Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function

Time frame: 9 months

Population: 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.

ArmMeasureValue (NUMBER)
Text-based Reminder for HPV Vaccine/WCCPercentage of Participants Receiving HPV Vaccination (Dose 2)6 percentage of eligible participants
Control ArmPercentage of Participants Receiving HPV Vaccination (Dose 2)7 percentage of eligible participants
Secondary

Percentage of Participants Receiving HPV Vaccination (Dose 3)

Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function

Time frame: 9 months

Population: 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.

ArmMeasureValue (NUMBER)
Text-based Reminder for HPV Vaccine/WCCPercentage of Participants Receiving HPV Vaccination (Dose 3)2 percentage of eligible participants
Control ArmPercentage of Participants Receiving HPV Vaccination (Dose 3)2 percentage of eligible participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026