Population Versus Practice-based Interventions to Increase Immunizations

Study Overview
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Brief Summary
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One of the nation's major health priorities, as outlined in Healthy People 2010, is to increase the proportion of children aged 19 to 35 months who have received all universally recommended vaccines. This study will compare two interventions for increasing immunization rates in this age group, one using well-studied primary care practice-based methods and the other using innovative technologies to increase immunization rates at the population-level. Results of this study will provide data that will be relevant nationally in guiding future investment of resources to increase up-to-date rates in young children prior to school entry. Hypothesis: Population-based approaches will be more effective than practice-based interventions at increasing immunizations among 19-35 month olds.

Official Title
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Population Versus Practice-based Interventions to Increase Immunizations

Conditions
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Health Services Research, Comparative Effectiveness, Immunization

Intervention / Treatment
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* Behavioral: Recall conducted by private practices
* Behavioral: Recall conducted centrally by local health department


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child between the age of 19-35 months has an address in a specified study county in the state immunization registry child is in need of at least one recommended immunization Exclusion Criteria: child has opted out of the state immunization registry child is up-to-date on all recommended immunizations

Ages Eligible for Study
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Minimum Age: 19 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Population-based Reminder/Recall<br>Recall is performed centrally by public health departments for all children in need of immunizations in a geographic area. | Behavioral: Recall conducted centrally by local health department<br>* A centralized recall of children 19-35 months will be conducted through local health departments. CIIS will identify a cohort of 19-35 month olds with an who are in need of an immunization and will coordinate up to 3 mailers to children who are not current for recommended immunizations.<br>|
| Experimental: Practice-based Reminder/Recall<br>Reminder/Recall is performed by individual private practices for their patients who appear in need of immunizations. | Behavioral: Recall conducted by private practices<br>* All practices in these counties will receive training on practice-based R/R using the Colorado Immunization Information System (CIIS or immunization registry). Practices will receive a recommended schedule for conducting recall in 19-35 month children and educational materials to use within their practices to promote compliance with the infant vaccination schedule. Individual practices will make their own decisions about the extent to which they follow the recommendations and implement recall within their practice. Although the study team will not provide them with any additional interventions, we will track any other interventions they independently do (websites, newsletters, telephone informational systems) in order to assess the effect of these additional interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate effectiveness of population-based reminder/recall methods versus practice-based reminder/recall methods in 14 Colorado counties (rural and urban) | The primary outcome measures will be: 1) change in up-to-date rates from baseline levels 6 months after the intervention (T-1) for 19-35 month olds in population-based compared to practice-based intervention counties and 2) percent of children who were not up-to-date prior to recall (T-0) who received any additional new vaccine in each type of intervention county. | 6 months post-intervention (December 2010) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reminder/recall messages, reminders, recall, immunizations, immunization information systems, effectiveness of reminder/recall, population-based reminder/recall