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

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ClinicalTrials.gov Identifier: NCT01557621
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : December 16, 2015
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE March 15, 2012
First Posted Date  ICMJE March 19, 2012
Last Update Posted Date December 16, 2015
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
  • 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 ACIP recommended series of antigens (4:3:1:3:3:1:3) to be received by the age of 19-20 months. Four 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Effectiveness Trial of Two Reminder/Recall Methods to Increase Immunization Rates in Young Children
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Immunization Rates
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Collaborative Pop-Based R/R: Phone/Mail Group
  • 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.
    Intervention: Behavioral: Collaborative Pop-Based R/R: Mail-Only Group
  • Active Comparator: Practice-based Recall
    Practice-based Recall
    Intervention: Behavioral: Practice-based Recall
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2012)
68000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Months to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01557621
Other Study ID Numbers  ICMJE 11-1480
P01HS021138 ( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Allison Kempe, MD, MPH University of Colorado Denver, The Children's Hospital of Colorado
PRS Account University of Colorado, Denver
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP