Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Human Papillomavirus Infection

Intervention / Treatment
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* Other: Assessment Feedback Incentives and eXchange
* Other: Physician-to-physician engagement
* Other: Active Intervention Control


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AFIX<br>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). | Other: Assessment Feedback Incentives and eXchange<br>* 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.<br>* Other names: AFIX;|
| Experimental: Physician-to-physician engagement<br>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). | Other: Physician-to-physician engagement<br>* 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.<br>* Other names: P2P;|
| Experimental: AFIX + P2P<br>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). | Other: Assessment Feedback Incentives and eXchange<br>* 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.<br>* Other names: AFIX;Other: Physician-to-physician engagement<br>* 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.<br>* Other names: P2P;|
| Other: Active Intervention Control<br>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). | Other: Active Intervention Control<br>* Active Intervention Control will be a remotely delivered quality improvement strategy on a clinical topic other than HPV vaccination.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality improvement, HPV vaccine