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Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03442062
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Other: Assessment Feedback Incentives and eXchange Other: Physician-to-physician engagement Other: Active Intervention Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of AFIX and Physician-to-Physician Engagement on HPV Vaccination in Primary Care: A Randomized Controlled Trial
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: AFIX
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
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.
Other Name: AFIX

Experimental: Physician-to-physician engagement
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
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.
Other Name: P2P

Experimental: AFIX + P2P
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
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.
Other Name: AFIX

Other: 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.
Other Name: P2P

Active Intervention Control
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
Active Intervention Control will be a remotely delivered quality improvement strategy on a clinical topic other than HPV vaccination.
Other Name: Control




Primary Outcome Measures :
  1. HPV vaccination (≥1 dose), 11-12 year olds at 12 months [ Time Frame: 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 Outcome Measures :
  1. HPV vaccination (≥1 dose), 11-12 year olds at 6 months [ Time Frame: 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

  2. HPV vaccination (≥1 dose), 11-12 year olds at six months by state [ Time Frame: 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)

  3. HPV vaccination (≥1 dose), 11-12 year olds at 12 months by state [ Time Frame: 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)

  4. HPV vaccination (≥1 dose), 11-12 year olds at 18 months [ Time Frame: 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

  5. HPV vaccination (≥1 dose), 11-12 year olds at 18 months by state [ Time Frame: 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).

  6. HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months [ Time Frame: 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

  7. HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at six months by state [ Time Frame: 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)

  8. HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months [ Time Frame: 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

  9. HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months by state [ Time Frame: 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)

  10. HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months [ Time Frame: 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

  11. HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months by state [ Time Frame: 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)

  12. HPV vaccination (≥1 dose), 13-17 year olds at six months [ Time Frame: 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

  13. HPV vaccination (≥1 dose), 13-17 year olds at 12 months [ Time Frame: 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

  14. HPV vaccination (≥1 dose), 13-17 year olds at 18 months [ Time Frame: 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

  15. HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at six months [ Time Frame: 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

  16. HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 12 months [ Time Frame: 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

  17. HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 18 months [ Time Frame: 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


Other Outcome Measures:
  1. Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds [ Time Frame: 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

  2. Meningococcal vaccination (≥1 dose), 11-12 year olds [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442062


Locations
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United States, Arizona
Arizona Department of Health Services
Phoenix, Arizona, United States, 85007
United States, New York
New York State Department of Health
Albany, New York, United States, 12237
United States, Wisconsin
Wisconsin Department of Health Services
Madison, Wisconsin, United States, 53703
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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
Investigators
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Principal Investigator: Noel T Brewer, PhD University of North Carolina
Principal Investigator: Melissa B Gilkey, PhD University of North Carolina

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03442062     History of Changes
Other Study ID Numbers: 18-0146a
1U01IP001073-01 ( U.S. NIH Grant/Contract )
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
quality improvement
HPV vaccine

Additional relevant MeSH terms:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs