Population Versus Practice-based Interventions to Increase Immunizations

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ClinicalTrials.gov Identifier: NCT01296906

Recruitment Status : Completed

First Posted : February 16, 2011

Last Update Posted : June 21, 2013

Sponsor:

Collaborator:

National Library of Medicine (NLM)

Information provided by (Responsible Party):

University of Colorado, Denver

Study Description

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

Study Design


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

Arms and Interventions

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.

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.

Outcome Measures

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) ]
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	19 Months and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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 ClinicalTrials.gov identifier (NCT number): NCT01296906

Locations


United States, Colorado

Denver, Colorado, United States

Sponsors and Collaborators

University of Colorado, Denver

National Library of Medicine (NLM)

Investigators


Principal Investigator:	Allison Kempe, MD, MPH	University of Colorado, Denver

More Information

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT01296906 History of Changes
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 reminders recall immunizations	immunization information systems effectiveness of reminder/recall population-based reminder/recall

Additional relevant MeSH terms:


Vaccines Immunologic Factors Physiological Effects of Drugs

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