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

Human Papillomavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03887793
• Other study ID #: 18-0146b
• Secondary ID: 1U01IP001073-01
• Status: Withdrawn
• Phase: N/A
• Start date: January 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: February 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	New York State Department of Health	Albany	New York
United States	Wisconsin Department of Health Services	Madison	Wisconsin

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV vaccination (=1 dose), 11-12 year olds at 6 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	Six months
Secondary	HPV vaccination (=1 dose), 11-12 year olds at 6 months by state	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)	Six months
Secondary	HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at 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	Six months
Secondary	HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months by state	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	Six months
Secondary	HPV vaccination (=1 dose), 13-17 year olds at 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	Six months
Secondary	HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 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	Six months