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

NCT ID: NCT01557621

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Immunization Rates

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Practice-based Recall

Practice-based Recall

Group Type: ACTIVE_COMPARATOR

Practice-based Recall

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 19 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison Kempe, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver, The Children's Hospital of Colorado

Locations

University of Colorado Denver

Aurora, Colorado, United States

Colorado Immunization Information System

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25706340 (View on PubMed)

Other Identifiers

P01HS021138

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

11-1480

Identifier Type: -

Identifier Source: org_study_id