Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination

University of North Carolina (UNC)

Status: Completed

Conditions: Human Papillomavirus Infection

Treatments: Other: Assessment Feedback Incentives and eXchange; Other: Active Intervention Control; Other: Physician-to-physician engagement

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03442062

1U01IP001073-01 (U.S. NIH Grant/Contract)

18-0146a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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264 participants in 4 patient groups

AFIX

Experimental group

Description:

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).

Treatment:

Other: Assessment Feedback Incentives and eXchange

Physician-to-physician engagement

Experimental group

Description:

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).

Treatment:

Other: Physician-to-physician engagement

AFIX + P2P

Experimental group

Description:

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).

Treatment:

Other: Physician-to-physician engagement

Other: Assessment Feedback Incentives and eXchange

Active Intervention Control

Other group

Description:

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).

Treatment:

Other: Active Intervention Control