Ignite Creation Date:
2024-05-06 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01806714
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2013-03-05
Brief Title:
Text Reminders to Immunize in a Managed Care Organization
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Text Reminders to Immunize in a Managed Care Organization
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIO
Brief Summary:
The purpose of the study is to evaluate the effectiveness of a managed care-based HPV vaccination reminderrecall system using a randomized controlled trial RCT across diverse practices and patient populations The trial will measure the effectiveness of text messaging reminderrecall 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 ie 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
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 ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None