Clinical trial NCT03442062: Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination
Official title: Impact of AFIX and Physician-to-Physician Engagement on HPV Vaccination in Primary Care: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Infection
Keywords: quality improvement
HPV vaccine
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: New York State Department of Health
name: Wisconsin Department of Health and Family Services
name: Arizona Department of Health Services
name: Association of Immunization Managers
First posted: 2018-02-22
Enrollment: 264
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Less than 200 active records for patients between 11-17

Primary outcomes:
measure: HPV vaccination (≥1 dose), 11-12 year olds at 12 months
timeFrame: Twelve months
Secondary outcomes:
measure: HPV vaccination (≥1 dose), 11-12 year olds at 6 months
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 11-12 year olds at six months by state
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 11-12 year olds at 12 months by state
timeFrame: Twelve months
measure: HPV vaccination (≥1 dose), 11-12 year olds at 18 months
timeFrame: Eighteen months
measure: HPV vaccination (≥1 dose), 11-12 year olds at 18 months by state
timeFrame: Eighteen 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 ACIP guidelines), 11-12 year olds at six months by state
timeFrame: Six months
measure: HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months
timeFrame: Twelve months
measure: HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months by state
timeFrame: Twelve months
measure: HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months
timeFrame: Eighteen months
measure: HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months by state
timeFrame: Eighteen months
measure: HPV vaccination (≥1 dose), 13-17 year olds at six months
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 13-17 year olds at 12 months
timeFrame: Twelve months
measure: HPV vaccination (≥1 dose), 13-17 year olds at 18 months
timeFrame: Eighteen months
measure: HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at six months
timeFrame: Six months
measure: HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 12 months
timeFrame: Twelve months
measure: HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 18 months
timeFrame: Eighteen months
Other outcomes:
measure: Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds
timeFrame: Twelve months
measure: Meningococcal vaccination (≥1 dose), 11-12 year olds
timeFrame: Twelve months
Locations:
city: Phoenix
country: United States
facility: Arizona Department of Health Services
state: Arizona
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: