Human Papillomavirus Infection
Conditions
Keywords
quality improvement, HPV vaccine
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.
Interventions
OTHERAssessment 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.
OTHERPhysician-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.
OTHERActive Intervention Control
Active Intervention Control will be a remotely delivered quality improvement strategy on a clinical topic other than HPV vaccination.
Sponsors
Centers for Disease Control and Prevention
New York State Department of Health
Wisconsin Department of Health and Family Services
Arizona Department of Health Services
Association of Immunization Managers
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (≥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), 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 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 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 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 (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), 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), 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), 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 (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 (≥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 (≥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 (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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds | Twelve months | Coverage change from baseline to twelve months in Tdap vaccination among 11- to 12-year-old patients, as measured by states' IIS records |
| Meningococcal vaccination (≥1 dose), 11-12 year olds | Twelve months | 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 |
Countries
United States
Outcome results
None listed