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Clinical Trials/NCT02133391
NCT02133391CompletedNot Applicable

Agency for Healthcare Research and Quality R18: Accountable Care Organizations (ACO)/ Public Health Collaborative Preventive Care Delivery to Priority Populations

University of Colorado, Denver2 sites in 1 country78,354 target enrollmentStarted: February 18, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
78,354
Locations
2
Primary Endpoint
Effectiveness of Vaccination Reminder/Recall

Study Overview

Brief Summary

This study focuses on implementing and evaluating an evidence-based collaborative method of increasing immunization rates among preschool children, adolescents and adults within an Accountable Care Organization-Public Health collaborative. The infrastructure we will create through this project will serve as the framework for future collaborative delivery of other preventive services.

Detailed Description

The current project leverages newly formed Regional Care Collaborative Organizations (RCCO) in Colorado that are charged with providing comprehensive care for children and adults insured by Medicaid. With a new RCCO-public health collaborative we will implement a randomized controlled trial to test the effectiveness of 1) evidence-based collaborative centralized method of increasing immunization delivery using reminder/recall techniques versus 2) traditional practice-based reminder/recall techniques that are done by individual practices (not centrally) or usual care from their provider. These interventions have been previously developed by the study team in different clinical settings. The project will examine the collaborative centralized approach, implemented within the new RCCO-public health collaborative first among preschool children, the group in which it has been previously studied. We will then extend the method to new populations, including adolescents and adults within the RCCO and Denver Health (adults only), and will evaluate the effectiveness of the intervention in each population.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Months to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients enrolled in Regional Care Collaborative Organizations (RCCOs) study practices in the regions covered by Colorado Access,
  • Age 19-35 months,
  • Age 11-17 years, or
  • Age 18 years and older.
  • Require an immunization according to Advisory Committee on Immunization Practices (ACIP) guidelines,
  • Adult (18 and older) patients at 8 primary care sites who are enrolled in Denver Health and patients at 6 primary care RCCO study practices

Exclusion Criteria

  • Any child whose parents have requested removal from the immunization registry;
  • Any adult who has requested removal from the immunization registry;
  • Any child or adult with hypersensitivity to any component of one of the recommended vaccines;
  • Any child or adult who has moved to a primary care provider other than one at the study practices.

Arms & Interventions

Practice-based reminder/recall or Usual care arm

Active Comparator

Practices participating in state immunization registry invited to reminder/recall (R/R) webinar trainings and provided educational materials to encourage immunization within their practices (child and adolescent trials only)

Patients not randomized to the collaborative centralized R/R arm will receive usual care from their provider, which does not include R/R (adult trials only)

Intervention: Practice-based Reminder/Recall (Other)

Collaborative centralized R/R

Experimental

Collaborative centralized reminder/recall (R/R) effort will be conducted by state immunization registry in collaboration with accountable care organizations and practices

Intervention: Centralized Reminder/Recall (R/R) (Other)

Outcomes

Primary Outcomes

Effectiveness of Vaccination Reminder/Recall

Time Frame: 2015-2017 (Year 2-4)

1. Comparisons of receipt of any recommended vaccine and all recommended vaccines by study arm 2. Comparisons of receipt of all needed vaccines 3. Comparisons of receipt of specific targeted vaccines

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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