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Population Versus Practice-based Interventions to Increase Immunizations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01296906
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : June 21, 2013
National Library of Medicine (NLM)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Health Services Research Comparative Effectiveness Immunization Behavioral: Recall conducted by private practices Behavioral: Recall conducted centrally by local health department Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31567 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Population Versus Practice-based Interventions to Increase Immunizations
Study Start Date : May 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: Population-based Reminder/Recall
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
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.

Experimental: Practice-based Reminder/Recall
Reminder/Recall is performed by individual private practices for their patients who appear in need of immunizations.
Behavioral: Recall conducted by private practices
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.

Primary Outcome Measures :
  1. Evaluate effectiveness of population-based reminder/recall methods versus practice-based reminder/recall methods in 14 Colorado counties (rural and urban) [ Time Frame: 6 months post-intervention (December 2010) ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01296906

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United States, Colorado
Denver, Colorado, United States
Sponsors and Collaborators
University of Colorado, Denver
National Library of Medicine (NLM)
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Principal Investigator: Allison Kempe, MD, MPH University of Colorado, Denver
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver Identifier: NCT01296906    
Other Study ID Numbers: 10-0823
1RC1LM010513-01 ( U.S. NIH Grant/Contract )
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by University of Colorado, Denver:
Reminder/recall messages
immunization information systems
effectiveness of reminder/recall
population-based reminder/recall