Clinical trial NCT01557621: Comparative Effectiveness Trial of Two Reminder/Recall Methods to Increase Immunization Rates in Young Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization Rates
Keywords: Immunization reminder/recall
Reminder/Recall systems
Population based Recall
Practice based Recall
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-03-19
Enrollment: 68000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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 counties
timeFrame: every 6 months for 2 years
measure: 2) Change in percent of children (who needed an immunization at baseline) who received any additional vaccines in each type of intervention county.
timeFrame: every 6 months for two years
Secondary outcomes:
measure: Cost Analysis of Collaborative Population-based Recall versus Practice-based Recall
timeFrame: 2 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Denver
country: United States
facility: Colorado Immunization Information System
state: Colorado
Study officials:
affiliation: University of Colorado Denver, The Children's Hospital of Colorado
name: Allison Kempe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kempe A, Saville AW, Dickinson LM, Beaty B, Eisert S, Gurfinkel D, Brewer S, Shull H, Herrero D, Herlihy R. Collaborative centralized reminder/recall notification to increase immunization rates among young children: a comparative effectiveness trial. JAMA Pediatr. 2015 Apr;169(4):365-73. doi: 10.1001/jamapediatrics.2014.3670.