Accountable Care Organizations/ Public Health Collaborative

NCT ID: NCT02133391

Last Updated: 2017-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-18
• Study Completion Date: 2017-07-14

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.

Conditions

Immunization Reminder System

Keywords

Accountable Care Organization; Comparative Effectiveness Research; Immunization/statistics & numerical data; Medicaid; Reminder Systems/economics; Reminder Systems/statistics & numerical data

Study Design

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

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Practice-based Reminder/Recall

Intervention Type: OTHER

Method of increasing immunization delivery using reminder/recall techniques, which are implemented at the practice level.

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

Group Type: EXPERIMENTAL

Centralized Reminder/Recall (R/R)

Intervention Type: OTHER

Method of increasing immunization delivery using reminder/recall techniques, which are implemented centrally.

Interventions

Centralized Reminder/Recall (R/R)

Method of increasing immunization delivery using reminder/recall techniques, which are implemented centrally.

Intervention Type: OTHER

Practice-based Reminder/Recall

Method of increasing immunization delivery using reminder/recall techniques, which are implemented at the practice level.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Months
• 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 School of Medicine, Children's Outcomes Research Program, Children's Hospital of Colorado

Locations

Children's Outcomes Research Program, University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31193580 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29910118 (View on PubMed)

Other Identifiers

13-2395

Identifier Type: -

Identifier Source: org_study_id