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

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

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.

Study Overview

• Status: Completed
• Conditions: Immunization Reminder System
• Intervention / Treatment: Other: Practice-based Reminder/Recall; Other: Centralized Reminder/Recall (R/R)

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 Type: Interventional
• Enrollment (Actual): 78354
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Outcomes Research Program, University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of Vaccination Reminder/Recall	Comparisons of receipt of any recommended vaccine and all recommended vaccines by study arm; Comparisons of receipt of all needed vaccines; Comparisons of receipt of specific targeted vaccines	2015-2017 (Year 2-4)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Allison Kempe, MD, MPH, University of Colorado School of Medicine, Children's Outcomes Research Program, Children's Hospital of Colorado

Publications and helpful links

General Publications

• Hurley LP, Beaty B, Lockhart S, Gurfinkel D, Dickinson LM, Roth H, Kempe A. Randomized controlled trial of centralized vaccine reminder/recall to improve adult vaccination rates in an accountable care organization setting. Prev Med Rep. 2019 May 22;15:100893. doi: 10.1016/j.pmedr.2019.100893. eCollection 2019 Sep.
• Hurley LP, Beaty B, Lockhart S, Gurfinkel D, Breslin K, Dickinson M, Whittington MD, Roth H, Kempe A. RCT of Centralized Vaccine Reminder/Recall for Adults. Am J Prev Med. 2018 Aug;55(2):231-239. doi: 10.1016/j.amepre.2018.04.022. Epub 2018 Jun 15.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2015
• Primary Completion (Actual): July 14, 2017
• Study Completion (Actual): July 14, 2017

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 8, 2014

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Accountable Care Organization; Comparative Effectiveness Research; Immunization/statistics & numerical data; Medicaid; Reminder Systems/economics; Reminder Systems/statistics & numerical data
• Other Study ID Numbers: 13-2395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No