Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination

Human Papillomavirus Infection Clinical Trial

Official title:

Impact of AFIX and Physician-to-Physician Engagement on HPV Vaccination in Primary Care: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442062
• Other study ID #: 18-0146a
• Secondary ID: 1U01IP001073-01
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: April 30, 2020

Study information

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

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Other:
• Assessment Feedback Incentives and eXchange
The adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components.
• Physician-to-physician engagement
Physician-to-physician engagement is a quality improvement strategy in which trained physician educators deliver a 60 minute consultation via interactive webinar. The consultations will be delivered to providers in primary care clinics and will include didactic instruction on HPV-related cancers, HPV vaccination, communication training, and assessment and feedback about each clinics' vaccination coverage.
• Active Intervention Control
Active Intervention Control will be a remotely delivered quality improvement strategy on a clinical topic other than HPV vaccination.

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
United States	Arizona Department of Health Services	Phoenix	Arizona

Sponsors (6)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Arizona Department of Health Services, 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
Other	Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds	Coverage change from baseline to twelve months in Tdap vaccination among 11- to 12-year-old patients, as measured by states' IIS records	Twelve months
Other	Meningococcal vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to twelve months in meningococcal vaccination (=1 dose), among 11- to 12- year-old patients, as measured by states' IIS records	Twelve months
Primary	HPV vaccination (=1 dose), 11-12 year olds at 12 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	Twelve months
Secondary	HPV vaccination (=1 dose), 11-12 year olds at 6 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	Six months
Secondary	HPV vaccination (=1 dose), 11-12 year olds at six months by state	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)	Six months
Secondary	HPV vaccination (=1 dose), 11-12 year olds at 12 months by state	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)	Twelve months
Secondary	HPV vaccination (=1 dose), 11-12 year olds at 18 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	Eighteen months
Secondary	HPV vaccination (=1 dose), 11-12 year olds at 18 months by state	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).	Eighteen 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 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, as measured by states' IIS records, stratifying by state (NY, WI, or AZ)	Six months
Secondary	HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 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	Twelve months
Secondary	HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months by state	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)	Twelve months
Secondary	HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 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	Eighteen months
Secondary	HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months by state	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)	Eighteen 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 (=1 dose), 13-17 year olds at 12 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	Twelve months
Secondary	HPV vaccination (=1 dose), 13-17 year olds at 18 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	Eighteen 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
Secondary	HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 12 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	Twelve months
Secondary	HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 18 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	Eighteen months