Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination

NCT03442062 | Completed

• 2 other identifiers: 18-0146a1U01IP001073-01
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 3

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.

Conditions

Human Papillomavirus Infection

Keywords

quality improvement; HPV vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• HPV vaccination (≥1 dose), 11-12 year olds at 6 months

  Six months

• HPV vaccination (≥1 dose), 11-12 year olds at six months by state

  Six months

• HPV vaccination (≥1 dose), 11-12 year olds at 12 months by state

  Twelve months

• HPV vaccination (≥1 dose), 11-12 year olds at 18 months

  Eighteen months

• HPV vaccination (≥1 dose), 11-12 year olds at 18 months by state

  Eighteen months

Other Outcomes (2)

• Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds

  Twelve months

• Meningococcal vaccination (≥1 dose), 11-12 year olds

  Twelve months

Study Arms (4)

AFIX

EXPERIMENTAL

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

Physician-to-physician engagement

EXPERIMENTAL

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

AFIX + P2P

EXPERIMENTAL

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; Other: Physician-to-physician engagement

Active Intervention Control

OTHER

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

Interventions

Assessment Feedback Incentives and eXchange OTHER

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.

Also known as: AFIX

AFIX; AFIX + P2P

Physician-to-physician engagement OTHER

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.

Also known as: P2P

AFIX + P2P; Physician-to-physician engagement

Active Intervention Control OTHER

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

Also known as: Control

Active Intervention Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Less than 200 active records for patients between 11-17

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Centers for Disease Control and Prevention: collaborator
• New York State Department of Health: collaborator
• Wisconsin Department of Health and Family Services: collaborator
• Arizona Department of Health Services: collaborator
• Association of Immunization Managers: collaborator

Study Sites (3)

Arizona Department of Health Services

Phoenix, Arizona, 85007, United States

Location

New York State Department of Health

Albany, New York, 12237, United States

Location

Wisconsin Department of Health Services

Madison, Wisconsin, 53703, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Noel T Brewer, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Melissa B Gilkey, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: May 7, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Locations

US (3)