Clinical trial NCT03887793: Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination in Integrated Healthcare Delivery Systems
Official title: Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination in Integrated Healthcare Delivery Systems
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Human Papillomavirus Infection
Keywords: quality improvement
HPV vaccine
integrated healthcare delivery systems
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: American Cancer Society, Inc.
name: Wisconsin Department of Health and Family Services
name: New York State Department of Health
name: Association of Immunization Managers
First posted: 2019-03-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HPV vaccination (≥1 dose), 11-12 year olds at 6 months
timeFrame: Six months
Secondary outcomes:
measure: HPV vaccination (≥1 dose), 11-12 year olds at 6 months by state
timeFrame: Six months
measure: HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months
timeFrame: Six months
measure: HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months by state
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 13-17 year olds at six months
timeFrame: Six months
measure: HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at six months
timeFrame: Six months
Other outcomes:
Locations:
city: Albany
country: United States
facility: New York State Department of Health
state: New York
city: Madison
country: United States
facility: Wisconsin Department of Health Services
state: Wisconsin
Study officials:
affiliation: University of North Carolina
name: Noel T Brewer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Melissa B Gilkey, PhD
role: PRINCIPAL_INVESTIGATOR
References: