Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination in Integrated Healthcare Delivery Systems

NCT ID: NCT03887793

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2020-07-31

Brief Summary

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HPV vaccination coverage is at lower levels than the national goal. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescent within the context of large integrated health care delivery systems.

Detailed Description

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The University of North Carolina (UNC) will evaluate the impact of a quality improvement (QI) model for increasing HPV vaccination coverage among adolescents in primary care settings. UNC will partner with the American Cancer Society (ACS) to evaluate the effectiveness of their Vaccinate Adolescents against Cancer (VACs) model for HPV vaccine QI within the context of integrated healthcare delivery systems (IDSs). The VACs model includes the development of a QI action plan and a QI team. The QI team is made up of health care providers from participating clinics within the IDSs. The team then helps implement specific QI activities in participating primary care clinics. The model also includes vaccination coverage assessments in participating clinics at multiple time points to assess the impact of QI activities. Specific QI activities that will be offered to participating clinics will be chosen from a menu of options that will include the Center for Disease Control and Prevention's AFIX model and physician-to-physician engagement. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. Physician-to-physician (P2P) engagement consists of an in-depth training about how to make strong and effective HPV vaccination recommendations to primary care providers. The investigators will compare changes in HPV vaccination coverage between the quality improvement arm or wait list control arm.

Conditions

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Human Papillomavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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VACs intervention

Integrated healthcare delivery systems randomly assigned to this arm will participate in the Vaccinate Adolescents against Cancers (VACs) model for HPV vaccine QI. Specific QI activities will be chosen by healthcare system leadership and healthcare providers on the systems' QI teams.

Group Type EXPERIMENTAL

VACs

Intervention Type OTHER

The VACs (Vaccinate Adolescents against Cancer) model for HPV vaccine quality improvement is a strategy developed by the American Cancer Society to improve HPV vaccination coverage in large integrated health care delivery systems. It includes the development of a quality improvement (QI) action plan, the formation of a QI team of health care providers, education for the QI team about HPV-related disease burden and vaccine efficacy, HPV vaccine coverage assessments at several time points that are shared with individual clinics within the health are system, and the adoption of specific QI strategies by participating clinics in the health care system.

Wait list control

Integrated healthcare delivery systems randomly assigned to this arm will be placed on a waiting list to receive the intervention after the conclusion of the study period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VACs

The VACs (Vaccinate Adolescents against Cancer) model for HPV vaccine quality improvement is a strategy developed by the American Cancer Society to improve HPV vaccination coverage in large integrated health care delivery systems. It includes the development of a quality improvement (QI) action plan, the formation of a QI team of health care providers, education for the QI team about HPV-related disease burden and vaccine efficacy, HPV vaccine coverage assessments at several time points that are shared with individual clinics within the health are system, and the adoption of specific QI strategies by participating clinics in the health care system.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Integrated healthcare delivery systems headquartered in New York State or Wisconsin with at least 4 pediatric or internal medicine practices within the system.
* All clinics within the integrated healthcare delivery system must participate in the state immunization registry.

Exclusion Criteria

* Integrated healthcare delivery systems headquartered outside of New York State or Wisconsin.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Wisconsin Department of Health and Family Services

OTHER_GOV

Sponsor Role collaborator

New York State Department of Health

OTHER_GOV

Sponsor Role collaborator

Association of Immunization Managers

UNKNOWN

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noel T Brewer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Melissa B Gilkey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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New York State Department of Health

Albany, New York, United States

Site Status

Wisconsin Department of Health Services

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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1U01IP001073-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-0146b

Identifier Type: -

Identifier Source: org_study_id

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