Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

NCT01057888 | Completed Results

• 1 other identifier: RSRB00026761
• Study Type: interventional
• Target: 10,599
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immunization Status; Well Child Care Visit

Keywords

Immunization status for:; Tdap; Menactra; HPV (if female); Well child care visit

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Autodialer

EXPERIMENTAL

Autodialer reminder/recall

Other: Autodialer

Letters

EXPERIMENTAL

Mailed reminder letters

Other: Letters

Controls

NO INTERVENTION

Controls

Interventions

Autodialer OTHER

Autodialer telephone calls

Autodialer

Letters OTHER

Mailed reminder letters

Letters

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Centers for Disease Control and Prevention: collaborator

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Peter Szilagyi
• Organization: University of Rochester, Deparentment of Pediatrics

peter_szilagyi@urmc.rochester.edu

585 275-5798

Study Officials

• Peter G Szilagyi, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 27, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 20, 2016
• Results First Posted: November 16, 2012

Record last verified: 2015-12