Population Versus Practice-based Interventions to Increase Immunizations

NCT ID: NCT01296906

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31567 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-09-30

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.

Detailed Description

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Conditions

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Health Services Research Comparative Effectiveness Immunization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Population-based Reminder/Recall

Recall is performed centrally by public health departments for all children in need of immunizations in a geographic area.

Group Type EXPERIMENTAL

Recall conducted centrally by local health department

Intervention Type BEHAVIORAL

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.

Practice-based Reminder/Recall

Reminder/Recall is performed by individual private practices for their patients who appear in need of immunizations.

Group Type EXPERIMENTAL

Recall conducted by private practices

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

19 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Library of Medicine (NLM)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allison Kempe, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Denver, Colorado, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/s0749-3797(99)00118-x.

Reference Type BACKGROUND
PMID: 10806982 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 10806981 (View on PubMed)

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. doi: 10.1542/peds.112.5.1076.

Reference Type BACKGROUND
PMID: 14595049 (View on PubMed)

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. doi: 10.2105/ajph.94.3.423.

Reference Type BACKGROUND
PMID: 14998806 (View on PubMed)

Kempe A, Saville A, Dickinson LM, Eisert S, Reynolds J, Herrero D, Beaty B, Albright K, Dibert E, Koehler V, Lockhart S, Calonge N. Population-based versus practice-based recall for childhood immunizations: a randomized controlled comparative effectiveness trial. Am J Public Health. 2013 Jun;103(6):1116-23. doi: 10.2105/AJPH.2012.301035. Epub 2012 Dec 13.

Reference Type DERIVED
PMID: 23237154 (View on PubMed)

Other Identifiers

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1RC1LM010513-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-0823

Identifier Type: -

Identifier Source: org_study_id

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