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

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.

Study Overview

• Status: Completed
• Conditions: Human Papilloma Virus
• Intervention / Treatment: Other: Text-based reminder for recommended HPV vaccine or WCC; Other: Non-specific text-based reminder (general health tip)

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.

• Study Type: Interventional
• Enrollment (Actual): 3812
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Text-based reminder for recommended HPV vaccine or WCC; Patients due for a well visit or HPV vaccine received a text reminder
Active Comparator: Control arm; Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Receiving HPV Vaccination (Dose 1)	Participants who received HPV vaccine dose 1 Kaplan-Meier failure function	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Receiving HPV Vaccination (Dose 2)	Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function	9 months
Percentage of Participants Receiving HPV Vaccination (Dose 3)	Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function	9 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Cynthia M Rand, MD, MPH, University of Rochester

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 5, 2013
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (Estimate): March 7, 2013

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 5, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: HPV; HPV vaccination; Adolescent well care; Adolescent HPV immunization
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: 056103-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED