Clinical trial NCT01806714: Text Reminders to Immunize in a Managed Care Organization
Official title: Text Reminders to Immunize in a Managed Care Organization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus
Keywords: HPV vaccination
Adolescent well care
Adolescent HPV immunization
HPV
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 3812
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: Percentage of Participants Receiving HPV Vaccination (Dose 1)
timeFrame: 9 months
Secondary outcomes:
measure: Percentage of Participants Receiving HPV Vaccination (Dose 2)
timeFrame: 9 months
measure: Percentage of Participants Receiving HPV Vaccination (Dose 3)
timeFrame: 9 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Cynthia M Rand, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: