Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

Randomized Controlled Trial of an Automated, Managed Care-based Reminder/Recall System on Improving Rates of Immunization and Preventive Care Visits for Publically Insured Adolescents

The investigators will design and implement a randomized clinical trial to test, on a community-wide level, the effectiveness of managed care based tracking/reminder/recall on improving vaccination coverage among adolescents.

The investigators propose a randomized controlled trial to evaluate the effectiveness of reminder/recall for adolescents: 10,599 adolescents within the managed care organization (MCO) will be randomized into one of three arms: 1) mailed reminders, 2) autodialer telephone messages or 3) standard of care of their practice (no messages from the intervention).

Hypothesis 1: Reminder/recall will increase the receipt of immunizations and preventive services

Hypothesis 2: Telephone (autodialer) reminders will be more effective than mailed reminders

Hypothesis 3: The impact of reminders will be greatest for the most high-risk subgroups which have low baseline immunization rates.

Hypothesis 4: Mailed reminders will be more costly (and less effective) than telephone reminders.

Study Overview

• Status: Completed
• Conditions: Immunization Status; Well Child Care Visit
• Intervention / Treatment: Other: Autodialer; Other: Letters

• Study Type: Interventional
• Enrollment (Actual): 10599
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Member of the Monroe Plan for Medical Care (managed care organization)
• Patient of a participating practice
• Ages 10.75 to <18 years of age

Exclusion Criteria:

• Member of the Monroe Plan for Medical care for less than 6 months
• ICD-9 diagnosis of 999.4 for anaphylactic reaction to a vaccine or its components.
• Encephalopathy within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause
• Guillain-Barre- ICD-9 code is 357.0

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controls
Experimental: Autodialer; Autodialer reminder/recall	Other: Autodialer; Autodialer telephone calls
Experimental: Letters; Mailed reminder letters	Other: Letters; Mailed reminder letters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female))		12 months
Well Child Care Status	Received recommended well child care visit	12 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Peter G Szilagyi, MD, MPH, University of Rochester

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 25, 2010
• First Submitted That Met QC Criteria: January 26, 2010
• First Posted (Estimate): January 27, 2010

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Tdap; Menactra; Immunization status for:; HPV (if female); Well child care visit
• Other Study ID Numbers: RSRB00026761