Population Versus Practice-based Interventions to Increase Immunizations

Immunization Clinical Trial

Official title:

Population Versus Practice-based Interventions to Increase Immunizations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296906
• Other study ID #: 10-0823
• Secondary ID: 1RC1LM010513-01
• Status: Completed
• Phase: N/A
• First received: February 14, 2011
• Last updated: June 19, 2013
• Start date: May 2010
• Est. completion date: September 2012

Study information

• Verified date: June 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31567
• Est. completion date: September 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Months and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Comparative Effectiveness
• Health Services Research
• Immunization

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Library of Medicine (NLM)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Briss PA, Rodewald LE, Hinman AR, Shefer AM, Strikas RA, Bernier RR, Carande-Kulis VG, Yusuf HR, Ndiaye SM, Williams SM. Reviews of evidence regarding interventions to improve vaccination coverage in children, adolescents, and adults. The Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):97-140. Review. — View Citation

Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: a review of recent methodological developments. Am J Public Health. 2004 Mar;94(3):423-32. Review. — View Citation

Recommendations regarding interventions to improve vaccination coverage in children, adolescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):92-6. — View Citation

Tierney CD, Yusuf H, McMahon SR, Rusinak D, O' Brien MA, Massoudi MS, Lieu TA. Adoption of reminder and recall messages for immunizations by pediatricians and public health clinics. Pediatrics. 2003 Nov;112(5):1076-82. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No