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Accountable Care Organizations/ Public Health Collaborative (ACO/PH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02133391
Recruitment Status : Completed
First Posted : May 8, 2014
Last Update Posted : September 29, 2017
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Immunization Reminder System Other: Centralized Reminder/Recall (R/R) Other: Practice-based Reminder/Recall Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Agency for Healthcare Research and Quality R18: Accountable Care Organizations (ACO)/ Public Health Collaborative Preventive Care Delivery to Priority Populations
Actual Study Start Date : February 18, 2015
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : July 14, 2017

Arm Intervention/treatment
Active Comparator: Practice-based reminder/recall or Usual care arm

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)

Other: Practice-based Reminder/Recall
Method of increasing immunization delivery using reminder/recall techniques, which are implemented at the practice level.

Experimental: Collaborative centralized R/R
Collaborative centralized reminder/recall (R/R) effort will be conducted by state immunization registry in collaboration with accountable care organizations and practices
Other: Centralized Reminder/Recall (R/R)
Method of increasing immunization delivery using reminder/recall techniques, which are implemented centrally.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02133391

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United States, Colorado
Children's Outcomes Research Program, University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Agency for Healthcare Research and Quality (AHRQ)
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Principal Investigator: Allison Kempe, MD, MPH University of Colorado School of Medicine, Children's Outcomes Research Program, Children's Hospital of Colorado
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver Identifier: NCT02133391    
Other Study ID Numbers: 13-2395
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Accountable Care Organization
Comparative Effectiveness Research
Immunization/statistics & numerical data
Reminder Systems/economics
Reminder Systems/statistics & numerical data