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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01557621
First received: March 15, 2012
Last updated: March 11, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention
Immunization Rates
Behavioral: Collaborative Pop-Based R/R: Phone/Mail Group
Behavioral: Practice-based Recall
Behavioral: Collaborative Pop-Based R/R: Mail-Only Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number (percent) of children who received ANY vaccination within the 6 month intervention period.


Secondary Outcome Measures:
  • Cost Analysis of Collaborative Population-based Recall versus Practice-based Recall [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 68000
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Collaborative Population-Based Recall
  1. Collaborative Pop-Based R/R: Phone/Mail Group
  2. 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: 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.
Active Comparator: Practice-based Recall
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.

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

Ages Eligible for Study:   19 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557621

Contacts
Contact: Allison Kempe, MD, MPH 303-724-1174 allison.kempe@childrenscolorado.org
Contact: Alison W. Saville, MSPH, MSW 303-724-0906 alison.saville@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Not yet recruiting
Aurora, Colorado, United States, 80045
Colorado Immunization Information System Recruiting
Denver, Colorado, United States, 80246-1530
Sub-Investigator: Rachel Herlihy, MD, MPH         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Allison Kempe, MD, MPH University of Colorado Denver, The Children's Hospital of Colorado
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01557621     History of Changes
Other Study ID Numbers: 11-1480, P01HS021138
Study First Received: March 15, 2012
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Colorado, Denver:
Immunization reminder/recall
Reminder/Recall systems
Population based Recall
Practice based Recall

ClinicalTrials.gov processed this record on July 24, 2014