Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Peter Szilagyi, University of Rochester
ClinicalTrials.gov Identifier:
NCT01057888
First received: January 25, 2010
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Immunization Status
Well Child Care Visit
Other: Autodialer
Other: Letters

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: 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

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female)) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Well Child Care Status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Received recommended well child care visit


Enrollment: 10599
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autodialer
Autodialer reminder/recall
Other: Autodialer
Autodialer telephone calls
Experimental: Letters
Mailed reminder letters
Other: Letters
Mailed reminder letters
No Intervention: Controls
Controls

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057888

Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Peter G Szilagyi, MD, MPH University of Rochester
  More Information

No publications provided

Responsible Party: Peter Szilagyi, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01057888     History of Changes
Other Study ID Numbers: RSRB00026761
Study First Received: January 25, 2010
Results First Received: October 18, 2012
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Immunization status for:
Tdap
Menactra
HPV (if female)
Well child care visit

ClinicalTrials.gov processed this record on April 15, 2014