Text Reminders to Immunize in a Managed Care Organization (TRIO)
Primary Purpose
Human Papilloma Virus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text-based reminder for recommended HPV vaccine or WCC
Non-specific text-based reminder (general health tip)
Sponsored by
About this trial
This is an interventional health services research trial for Human Papilloma Virus focused on measuring HPV vaccination, Adolescent well care, Adolescent HPV immunization, HPV
Eligibility Criteria
Inclusion Criteria:
- 11-<18 years
- Member of MCO for >6 months
- Opted in to receive texted reminders from MCO
Exclusion Criteria:
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Text-based reminder for HPV vaccine/WCC
Control arm
Arm 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
Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Outcomes
Primary Outcome Measures
Percentage of Participants Receiving HPV Vaccination (Dose 1)
Participants who received HPV vaccine dose 1 Kaplan-Meier failure function
Secondary Outcome Measures
Percentage of Participants Receiving HPV Vaccination (Dose 2)
Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function
Percentage of Participants Receiving HPV Vaccination (Dose 3)
Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01806714
Brief Title
Text Reminders to Immunize in a Managed Care Organization
Acronym
TRIO
Official Title
Text Reminders to Immunize in a Managed Care Organization
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
HPV vaccination, Adolescent well care, Adolescent HPV immunization, HPV
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3812 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Text-based reminder for HPV vaccine/WCC
Arm Type
Experimental
Arm 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
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Intervention Type
Other
Intervention Name(s)
Text-based reminder for recommended HPV vaccine or WCC
Intervention Description
Patients due for a well visit or HPV vaccine received a text reminder
Intervention Type
Other
Intervention Name(s)
Non-specific text-based reminder (general health tip)
Intervention Description
Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Primary Outcome Measure Information:
Title
Percentage of Participants Receiving HPV Vaccination (Dose 1)
Description
Participants who received HPV vaccine dose 1 Kaplan-Meier failure function
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Percentage of Participants Receiving HPV Vaccination (Dose 2)
Description
Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function
Time Frame
9 months
Title
Percentage of Participants Receiving HPV Vaccination (Dose 3)
Description
Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
11-<18 years
Member of MCO for >6 months
Opted in to receive texted reminders from MCO
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia M Rand, MD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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