Clinical trial NCT05336240: PCOM2 - The Physician Communication Intervention, Version 2.0
Official title: PCOM2 - The Physician Communication Intervention, Version 2.0" for "Linking the Provider Recommendation to Adolescent HPV Vaccine Uptake"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV Infection
Preventive Health Services
Keywords: Immunization
Provider Communication
HPV Prevention
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Kansas Medical Center
name: San Diego State University
First posted: 2022-04-20
Enrollment: 120
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Poor quality of primary care providers' vaccine recommendations lead to low adolescent human papillomavirus vaccination rates and hundreds of thousands of adolescents unnecessarily at risk for HPV-associated cancers and diseases. Though a previous provider communication intervention, called PCOM, was found to be effective for increasing adolescent HPV vaccination in primary care, its dissemination is limited by the need for significant research team involvement to teach providers how to use the intervention's components. To address this, investigators propose to develop and test a virtual version of PCOM, use mixed methods to assess contextual factors affecting its use compared to the original PCOM intervention, and develop an optimized version of PCOM for broad dissemination to increase adolescent HPV vaccination nationally.

Detailed description: The overarching goal is to develop a "Virtual" version of the PCOM intervention ("PCOM-Virtual") and compare its efficacy for increasing HPV vaccination among adolescents to that of the original PCOM intervention ("PCOM-Standard"). Using Dissemination \& Implementation (D\&I) science principles to develop and evaluate the PCOM-Virtual intervention for non-inferiority, investigators anticipate that to have a "shelf ready" intervention and associated "User Manual" that can be easily incorporated into practices broadly to improve the practice's adolescent HPV vaccination rates.

Specific Aims are to: (1) develop the "PCOM-Virtual" intervention using principles of D\&I Science; (2) compare the efficacy of "PCOM-Virtual" versus "PCOM-Standard" in improving adolescent HPV vaccine utilization; and (3) examine whether practice, patient and provider characteristics are associated with variability in the efficacy of PCOM-Virtual and PCOM-Standard.

Eligibility criteria: Inclusion Criteria:

* Parents: Have an adolescent between the ages of 9-17 years old and receiving adolescent care at an enrolled clinic
* Providers: All providers at participating study practices will be eligible to participate.

Exclusion Criteria:

* Parents: Does not have an adolescent between the ages of 9-17 years old and is not receiving adolescent care at an enrolled clinic
* Providers: Providers who are not at participating study practices

Primary outcomes:
measure: HPV vaccination initiation status in 11-12 year olds
timeFrame: Adolescent vaccination initiation status will be assessed among all "active" (seen in the last 12 months) 11 to 12-year-old patients at each practice during the last 12 months of the 24 month intervention period
Secondary outcomes:
measure: HPV series completion among 11-12 year olds
timeFrame: Adolescent vaccination completion status will be assessed among all "active" (seen in the last 12 months) 11 to 12-year-old patients at each practice during the last 12 months of the 24 month intervention period
measure: HPV vaccination initiation status in 13-17 year olds
timeFrame: Adolescent vaccination initiation status will be assessed among all "active" (seen in the last 12 months) 13-17-year-old patients at each practice during the last 12 months of the 24 month intervention period
measure: HPV series completion among 13-17 year olds
timeFrame: Adolescent vaccination completion status will be assessed among all "active" (seen in the last 12 months) 13-17-year-old patients at each practice during the last 12 months of the 24 month intervention period
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Wichita
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Colorado, Denver
name: Sean O'Leary, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: