Comparative Effectiveness Trial of Two Reminder/Recall Methods to Increase Immunization Rates in Young Children
|ClinicalTrials.gov Identifier: NCT01557621|
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : December 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Immunization Rates||Behavioral: Collaborative Pop-Based R/R: Phone/Mail Group Behavioral: Collaborative Pop-Based R/R: Mail-Only Group Behavioral: Practice-based Recall||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68000 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|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 Start Date :||September 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Collaborative Population-Based Recall-Phone/Mail Group
Collaborative Pop-Based R/R: Phone/Mail Group Private providers, local public health departments, and the state immunization registry (CIIS) collaborate to send notices to families whose children appear in need of an immunization.
Behavioral: Collaborative 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.
Experimental: Collaborative Population-Based Recall-Mail Only Group
Collaborative Pop-Based R/R: Mail-Only Group Private providers, local public health departments, and the state immunization registry (CIIS) collaborate to send notices to families whose children appear in need of an immunization.
Behavioral: Collaborative 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.
Active Comparator: Practice-based Recall
Behavioral: Practice-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.
- 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 [ Time Frame: every 6 months for 2 years ]The 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. [ Time Frame: every 6 months for two years ]Number (percent) of children who received ANY vaccination within the 6 month intervention period.
- Cost Analysis of Collaborative Population-based Recall versus Practice-based Recall [ Time Frame: 2 years ]
Number (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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557621
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Colorado Immunization Information System|
|Denver, Colorado, United States, 80246-1530|
|Principal Investigator:||Allison Kempe, MD, MPH||University of Colorado Denver, The Children's Hospital of Colorado|