Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination
- Conditions
- Human Papillomavirus Infection
- Interventions
- Other: Assessment Feedback Incentives and eXchangeOther: Physician-to-physician engagementOther: Active Intervention Control
- Registration Number
- NCT03442062
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
HPV vaccination is at lower levels than the national goals. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescents in primary care clinics.
- Detailed Description
The University of North Carolina will test the effectiveness of the Center for Disease Control and Prevention's AFIX model, physician-to-physician engagement, and both strategies in combination, for increasing HPV vaccination coverage among adolescents in primary care clinics. 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 physician educators providing feedback about clinics' current HPV vaccination coverage and in-depth training about how to make strong and effective HPV vaccination recommendations to primary care providers via remote webinar consultations. Physician educators will also use immunization registry data to provide feedback on clinics' vaccine coverage. The investigators will compare changes in HPV vaccination coverage before and after intervention for high-volume primary care clinics in four study conditions: AFIX consultations delivered in-person by state health department immunization specialists (AFIX group), physician-to-physician consultations delivered remotely by trained physician educators (P2P group), both AFIX and P2P consultations in combination (AFIX + P2P group), or no HPV quality improvement intervention (control group). In each state, 30 clinics will be randomly assigned to each study arm, for a total of 120 clinics per state, or 360 clinics overall. As a secondary endpoint, we proposed to evaluate the impact of intervention "booster" visits delivered at 12-months post-intervention. However, the CDC has recently changed the AFIX program so that the desired comparison is no longer possible. Therefore, we have eliminated booster visits. This change does not affect our primary endpoint. The primary objective of this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 12-month follow-up. Secondarily, the study will compare the change in coverage for other vaccines, age groups and time periods.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 264
- Pediatric or family medicine clinics or practices in New York, Wisconsin, or Arizona with at least 200 active records for patients, ages 11-17, in their states' immunization information systems.
- Less than 200 active records for patients between 11-17
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description AFIX Assessment Feedback Incentives and eXchange Clinics randomly assigned to this arm will receive an Assessment Feedback Incentives and eXchange (AFIX) consultation delivered in-person by a state health department immunization specialist.This arm includes \~ 90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). Physician-to-physician engagement Physician-to-physician engagement Clinics randomly assigned to this arm will receive physician-to-physician (P2P) consultations delivered remotely to providers by physician educators. This arm includes \~90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). Active Intervention Control Active Intervention Control Clinics randomly assigned to this arm will receive a brief non-HPV vaccine related quality improvement consultation. This arm includes \~90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). AFIX + P2P Assessment Feedback Incentives and eXchange Clinics randomly assigned to this arm will receive both an Assessment Feedback Incentives and eXchange (AFIX) consultation and a physician-to-physician (P2P) consultation.This arm includes \~90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). AFIX + P2P Physician-to-physician engagement Clinics randomly assigned to this arm will receive both an Assessment Feedback Incentives and eXchange (AFIX) consultation and a physician-to-physician (P2P) consultation.This arm includes \~90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona).
- Primary Outcome Measures
Name Time Method HPV vaccination (≥1 dose), 11-12 year olds at 12 months Twelve months Coverage change from baseline to twelve 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 (≥1 dose), 11-12 year olds at six months by state Six months Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY, WI or AZ)
HPV vaccination (≥1 dose), 11-12 year olds at 12 months by state Twelve months Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY, WI or AZ)
HPV vaccination (≥1 dose), 13-17 year olds at 18 months Eighteen months Coverage change from baseline to eighteen months in HPV vaccine initiation (≥1 dose), among 13- to 17- year-old patients, as measured by states' IIS records
HPV vaccination (≥1 dose), 11-12 year olds at 18 months Eighteen months Coverage change from baseline to eighteen months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records
HPV vaccination (≥1 dose), 11-12 year olds at 6 months Six months Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records
HPV vaccination (completion according to 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, as measured by states' IIS records, stratifying by state (NY, WI, or AZ)
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months Eighteen months Coverage change from baseline to eighteen months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records
HPV vaccination (≥1 dose), 11-12 year olds at 18 months by state Eighteen months Coverage change from baseline to eighteen months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY, WI, or AZ).
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), 11-12 year olds at 12 months Twelve months Coverage change from baseline to twelve months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records
HPV vaccination (≥1 dose), 13-17 year olds at 12 months Twelve months Coverage change from baseline to twelve 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 12 months Twelve months Coverage change from baseline to twelve months in HPV vaccine completion, among 13- to 17- year-old patients, as measured by states' IIS records
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months by state Twelve months Coverage change from baseline to twelve months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY, WI, or AZ)
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months by state Eighteen months Coverage change from baseline to eighteen months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY, WI, AZ)
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 ACIP guidelines), 13-17 year olds at 18 months Eighteen months Coverage change from baseline to eighteen months in HPV vaccine completion, 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 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 (3)
Arizona Department of Health Services
🇺🇸Phoenix, Arizona, United States
New York State Department of Health
🇺🇸Albany, New York, United States
Wisconsin Department of Health Services
🇺🇸Madison, Wisconsin, United States