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Objective: To assess the impact of a tiered patient immunization navigator intervention (immunization tracking, reminder/recall, and outreach) on improving immunization and preventive care visit rates in urban adolescents.

Design: Randomized clinical trial allocating adolescents (aged 11-15 years) to intervention vs standard of care control.

Setting: Eight primary care practices.

Participants: Population-based sample of adolescents (N = 7546).

Intervention: Immunization navigators at each practice implemented a tiered protocol: immunization tracking, telephone or mail reminder/recall, and home visits if participants remained unimmunized or behind on preventive care visits.

Main Outcome Measures: Immunization rates at study end. Secondary outcomes were preventive care visit rates during the previous 12 months and costs.

Results: The intervention and control groups were similar at baseline for demographics (mean age, 13.5 years; 63% black, 14% white, and 23% Hispanic adolescents; and 74% receiving Medicaid), immunization rates, and preventive care visit rates. Immunization rates at the end of the study were 44.7% for the intervention group and 32.4% for the control group (adjusted risk ratio, 1.4; 95% confidence interval, 1.3-1.5); preventive care visit rates were 68.0% for the intervention group and 55.2% for the control group (1.2; 1.2-1.3). Findings were similar across practices, sexes, ages, and insurance providers. The number needed to treat for immunizations and preventive care visits was 9. The intervention cost was $3.81 per adolescent per month; the cost per additional adolescent fully vaccinated was $465, and the cost per additional adolescent receiving a preventive care visit was $417.

Conclusion: A tiered tracking, reminder/recall, and outreach intervention improved immunization and preventive care visit rates in urban adolescents.

Trial Registration: clinicaltrials.gov Identifier: NCT00581347

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