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

Not Applicable

Withdrawn

• Conditions: Human Papillomavirus Infection
• Interventions: Other: VACs

• Registration Number: NCT03887793
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-25
• Study Start: 2020-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

• Integrated healthcare delivery systems headquartered outside of New York State or Wisconsin.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VACs intervention	VACs	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.

Primary Outcome Measures

Name	Time	Method
HPV vaccination (≥1 dose), 11-12 year olds at 6 months	Six months	Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 11- to 12- year old patients, as measured by states' immunization information system (IIS) records

Secondary Outcome Measures

Name	Time	Method
HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months by state	Six months	Coverage change from baseline to six months in HPV vaccine completion, among 11- to 12- year-old patients by state (NY or WI), as measured by states' IIS records
HPV vaccination (≥1 dose), 11-12 year olds at 6 months by state	Six months	Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY or WI)
HPV vaccination (≥1 dose), 13-17 year olds at six months	Six months	Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 13- to 17- year-old patients, as measured by states' IIS records
HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months	Six months	Coverage change from baseline to six months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records
HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at six months	Six months	Coverage change from baseline to six months in HPV vaccine completion, among 13- to 17- year-old patients, as measured by states' IIS records

Trial Locations

Locations (2)

Wisconsin Department of Health Services; 🇺🇸 Madison, Wisconsin, United States

New York State Department of Health; 🇺🇸 Albany, New York, United States