Population Versus Practice-based Interventions to Increase Immunizations

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01296906
First received: February 14, 2011
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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 Intervention
Health Services Research
Comparative Effectiveness
Immunization
Behavioral: Recall conducted by private practices
Behavioral: Recall conducted centrally by local health department

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Population Versus Practice-based Interventions to Increase Immunizations

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 31567
Study Start Date: May 2010
Study Completion Date: September 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296906

Locations
United States, Colorado
Denver, Colorado, United States
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Allison Kempe, MD, MPH University of Colorado, Denver
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01296906     History of Changes
Other Study ID Numbers: 10-0823, 1RC1LM010513-01
Study First Received: February 14, 2011
Last Updated: June 19, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
Reminder/recall messages
reminders
recall
immunizations
immunization information systems
effectiveness of reminder/recall
population-based reminder/recall

ClinicalTrials.gov processed this record on August 28, 2014