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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03887793
Enrollment
0
Registered
2019-03-25
Start date
2020-01-31
Completion date
2020-07-31
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus Infection

Keywords

quality improvement, HPV vaccine, integrated healthcare delivery systems

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.

Interventions

OTHERVACs

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.

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
American Cancer Society, Inc.
CollaboratorOTHER
Wisconsin Department of Health and Family Services
CollaboratorOTHER_GOV
New York State Department of Health
CollaboratorOTHER_GOV
Association of Immunization Managers
CollaboratorUNKNOWN
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
HPV vaccination (≥1 dose), 11-12 year olds at 6 monthsSix monthsCoverage 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

MeasureTime frameDescription
HPV vaccination (≥1 dose), 11-12 year olds at 6 months by stateSix monthsCoverage 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 (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six monthsSix monthsCoverage 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 the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months by stateSix monthsCoverage 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), 13-17 year olds at six monthsSix monthsCoverage 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 ACIP guidelines), 13-17 year olds at six monthsSix monthsCoverage change from baseline to six months in HPV vaccine completion, among 13- to 17- year-old patients, as measured by states' IIS records

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026