ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01057888
Recruitment Status : Completed
First Posted : January 27, 2010
Results First Posted : November 16, 2012
Last Update Posted : January 20, 2016
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Peter G Szilagyi MD MPH, University of Rochester

Brief Summary:

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 or disease Intervention/treatment Phase
Immunization Status Well Child Care Visit Other: Autodialer Other: Letters Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10599 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : December 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: Autodialer
Autodialer reminder/recall
Other: Autodialer
Autodialer telephone calls
Experimental: Letters
Mailed reminder letters
Other: Letters
Mailed reminder letters
No Intervention: Controls
Controls



Primary Outcome Measures :
  1. Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female)) [ Time Frame: 12 months ]
  2. Well Child Care Status [ Time Frame: 12 months ]
    Received recommended well child care visit



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057888


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

Responsible Party: Peter G Szilagyi MD MPH, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01057888     History of Changes
Other Study ID Numbers: RSRB00026761
First Posted: January 27, 2010    Key Record Dates
Results First Posted: November 16, 2012
Last Update Posted: January 20, 2016
Last Verified: December 2015

Keywords provided by Peter G Szilagyi MD MPH, University of Rochester:
Immunization status for:
Tdap
Menactra
HPV (if female)
Well child care visit