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A Cluster Randomized Controlled Trial

Simon J. Hambidge, MD, PhD; Arthur J. Davidson, MD, MSPH; Stephanie L. Phibbs, MPH; Vijayalaxmi Chandramouli, MS; Gary Zerbe, PhD; Charles W. LeBaron, MD; John F. Steiner, MD, MPH

Arch Pediatr Adolesc Med. 2004;158:162-169.

Objective  To measure the effect of a multimodal intervention on well-child care visit (WCV) and immunization rates in an inner-city population.

Design  Cluster randomized controlled trial.

Setting and Participants  One-year cohort of 2843 infants born at a hospital in an integrated inner-city health care system.

Interventions  Eleven clinics were randomly allocated to 1 of 3 study arms: WCV intervention (n = 3), immunization intervention (n = 4), and controls (n = 4). Interventions to improve immunization and WCV rates included both patient-based and clinic-based activities.

Main Outcome Measures  Up-to-date status with childhood immunizations and WCVs by age 12 months (primary) and health care utilization and charges (secondary).

Results  Compared with the control arm, the WCV and immunization arms had 5% to 6% higher immunization rates and 7% to 8% higher WCV rates. In multivariate analyses that accounted for the clustered nature of the data, the number of immunizations received was greater in the WCV arm than in controls. However, neither the WCV nor the immunization intervention increased WCV or immunization up-to-date rates. The WCV arm had slightly higher health care charges. Neither intervention affected emergency, urgent care or inpatient utilization.

Conclusions  This multimodal intervention produced a small increase in the number of childhood immunizations delivered. However, patient- and clinic-based methods did not lead to significant increases in WCV or immunization up-to-date rates after controlling for other factors. Methods found in some settings to increase immunization up-to-date rates may not be as effective in a population of inner-city socioeconomically disadvantaged children.

From the Departments of Pediatrics (Dr Hambidge), Preventive Medicine and Biometrics (Drs Davidson, Zerbe, and Steiner), and Family Medicine (Dr Davidson) and the Division of General Internal Medicine (Dr Steiner and Mss Phibbs and Chandramouli), University of Colorado Health Sciences Center, Denver; Denver Community Health Services, Denver Health (Drs Hambidge and Davidson); and the National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Ga (Dr LeBaron).

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