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

Resource links provided by NLM:


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
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: 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 October 22, 2014