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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
Cynthia Rand, University of Rochester
ClinicalTrials.gov Identifier:
NCT01806714
First received: March 5, 2013
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Human Papilloma Virus
Other: Text-based reminder for recommended HPV vaccine or well care visit
Other: Non-specific text-based reminder (general health tip)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Text Reminders to Immunize in a Managed Care Organization

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • HPV vaccination (dose 1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Well child care visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HPV vaccination (dose 2 or 3) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Text-based reminder for HPV vaccine/WCC
Parents of adolescents will receive text-based reminders if their adolescent is due for a recommended HPV vaccine (dose 1, 2 or 3) or well child care visit
Other: Text-based reminder for recommended HPV vaccine or well care visit
Active Comparator: Control arm
Parents of adolescents in the control arm will receive general preventive health tips via text messages (not specific to services for which their adolescent is due)
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-<18 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-<18 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

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806714

Contacts
Contact: Cynthia M Rand, MD, MPH 585 275-9316 cynthia_rand@urmc.rochester.edu
Contact: Christina Albertin, MPH 317 701-4926 christina_albertin@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Principal Investigator: Cynthia M Rand, MD, MPH         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Cynthia M Rand, MD, MPH University of Rochester
  More Information

No publications provided

Responsible Party: Cynthia Rand, Associate Professor of Pediatrics, University of Rochester
ClinicalTrials.gov Identifier: NCT01806714     History of Changes
Other Study ID Numbers: 056103-002
Study First Received: March 5, 2013
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
HPV vaccination
Adolescent well care
Adolescent HPV immunization
HPV

Additional relevant MeSH terms:
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014