Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

NCT ID: NCT01057888

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10599 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Autodialer

Autodialer reminder/recall

Group Type: EXPERIMENTAL

Autodialer

Intervention Type: OTHER

Autodialer telephone calls

Letters

Mailed reminder letters

Group Type: EXPERIMENTAL

Letters

Intervention Type: OTHER

Mailed reminder letters

Controls

Controls

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Autodialer

Autodialer telephone calls

Intervention Type: OTHER

Letters

Mailed reminder letters

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Peter G Szilagyi MD MPH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter G Szilagyi, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Other Identifiers

RSRB00026761

Identifier Type: -

Identifier Source: org_study_id