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Comparative Effectiveness Trial of Two Reminder/Recall Methods to Increase Immunization Rates in Young Children

Center for Research in Implementation Science and Prevention (CRISP): Project 1: Comparative Effectiveness Trial of Two Reminder/Recall Methods to Increase Immunization Rates in Young Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01557621
Enrollment
68000
Registered
2012-03-19
Start date
2012-09-30
Completion date
2015-12-31
Last updated
2015-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunization Rates

Keywords

Immunization reminder/recall, Reminder/Recall systems, Population based Recall, Practice based Recall

Brief summary

The purpose of this study is to determine if a collaborative centralized population-based reminder/recall intervention is more effective than a traditional practice-based reminder/recall intervention at increasing immunizations among young children.

Detailed description

The study proposed is of immense importance in directing future methodology for bringing children who have not received needed immunizations up to date. The proposed study builds on the success of a previous trial and incorporates data from providers and patients to further improve the intervention. In this study the investigators aim to increase the effectiveness, cost effectiveness, and acceptability to practices and families of population-based R/R by introducing a strong private-public collaboration and maximizing health information technologies that allow practices to interface with Colorado's Immunization Services System (CIIS). Two real-world approaches will be compared: one approach will provide primary care practices the tools to conduct recall and educational interventions. In the other approach, population-based centralized recall by the state immunization registry will be conducted in collaboration with practices. Determining which of these methods is most effective in reaching the most children and comparing the cost of each will provide data critical in guiding future national efforts to assure that children entering school are fully vaccinated. Because the trial will be conducted at the level of both urban and rural counties throughout the state and will include all types of providers, the investigators expect our findings to be nationally generalizable.

Interventions

BEHAVIORALCollaborative Pop-Based R/R: Phone/Mail Group

Within each county, half of patients will be randomized to a phone/mail group (2 auto-dialer calls and 2 postcards) and the other half of patients will be put in a mail-only group (4 mailings). The following collaborative approaches will be utilized: patient addresses and phone numbers will be updated prior to recall for electronic Flat File Format practices; all notices to parents (auto-dialer calls and mailings) will appear to come both from the local public health department and providers who choose to have their name listed; all bad addresses and phone numbers will be updated by calling the last provider of care. Up to 4 notices will be sent to parents of children who are still not up to date for recommended immunizations.

BEHAVIORALCollaborative Pop-Based R/R: Mail-Only Group

Parents will receive up to four mailings if their child appears in need of immunizations according to CIIS. The Collaborative method is the same as in the auto-dialer/mail group; however patients in this group will not receive telephone calls.

BEHAVIORALPractice-based Recall

All practices will receive training on how to conduct practice-based recall using CIIS 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) in order to assess the effect of these additional interventions.

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
19 Months to 5 Years
Healthy volunteers
No

Inclusion criteria

* 19-35 months at time of recall * has an address in a specified study county listed in the state immunization registry * child is in need of at least one immunization at time of study

Exclusion criteria

* Opted out of the Colorado Immunization Information System (CIIS) * child is up-to-date on all immunizations

Design outcomes

Primary

MeasureTime frameDescription
1) Change in up-to-date rates for 19- to 35-month-olds (who needed an immunization at baseline) in collaborative population-based counties compared to practice-based intervention countiesevery 6 months for 2 yearsThe definition of up-to-date is based on the national Advisory Committee on Immunization Practices(ACIP)recommended series of antigens (4:3:1:3:3:1:3) to be received by the age of 19-20 months. Three different cohorts of children aged 19-35 months will be assessed across the 3 year study period. Outcomes from each cohort will be assessed 6 months post-intervention.
2) Change in percent of children (who needed an immunization at baseline) who received any additional vaccines in each type of intervention county.every 6 months for two yearsNumber (percent) of children who received ANY vaccination within the 6 month intervention period.

Secondary

MeasureTime frameDescription
Cost Analysis of Collaborative Population-based Recall versus Practice-based Recall2 yearsNumber (percent) of identified children that became up-to-date for recommended immunizations. Number (percent) of shots delivered to children needing immunizations. Number (percent) or providers (sites) that conducted practice-based reminder recall.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026