Grant Number:	5R01CA254931-02 Interpret this number
Primary Investigator:	O'Leary, Sean
Organization:	University Of Colorado Denver
Project Title:	Pcom2 - the Physician Communication Intervention, Version 2.0
Fiscal Year:	2023

PROJECT SUMMARY/ABSTRACT Human Papillomaviruses (HPV) infect >90% of the population and cause >30,000 cervical, anogenital, and oropharyngeal cancers annually. HPV vaccines have been available in the US since 2006 but only 54% of 11- 12 years-olds are vaccinated - well below national goals of 80%. As the title of the PAR to which this applica- tion responds suggests (PAR-19-360), “Linking the Provider Recommendation to Adolescent HPV Vaccine Up- take” is a key strategy for increasing adolescent HPV vaccination. Many studies show that a primary driver of low adolescent HPV vaccination is a poor quality HPV vaccine recommendation from providers. While many interventions to address this have been developed, few have been found in rigorous trials to increase vaccina- tion and also be feasible to implement in busy clinical settings. An exception is the Physician Communication, or PCOM, intervention developed by our group. PCOM focuses on teaching providers to use a 2-step verbal communication process for their recommendation:1) start the vaccine discussion using a “presumptive” format (i.e. “Let's get the HPV vaccine done today”) and 2) use motivational interviewing (MI) techniques to address parental vaccine hesitancy, if needed. In a large, cluster-randomized trial, PCOM increased adolescent HPV vaccine initiation rates among 11-12 year olds by 8 percentage points (PP) more than controls– a relatively large effect size for a vaccination intervention. Limiting broad dissemination of PCOM is the significant level of research team facilitation needed to teach practices how to use the PCOM components. To address this, we propose to develop a “Virtual” version of the PCOM intervention (“PCOM-Virtual”) and test it for non-inferiority to the original PCOM intervention (“PCOM-Standard”) for increasing adolescent HPV vaccination. By using Dissemination & Implementation (D&I) science principles throughout the process and collecting information on how contextual practice, provider and patient factors influence PCOM use, we anticipate creating a “shelf ready” version of PCOM with an associated “User Manual” to foster dissemination. Our Aims are to: 1. Develop the “PCOM-Virtual” intervention using principles of D&I Science from existing prototypes. 2. Compare the efficacy of “PCOM-Virtual” vs. “PCOM-Standard” in improving adolescent HPV vac- cine utilization. A cluster-randomized non-inferiority trial will be conducted in 30 primary care practices in Kansas – a locale with some of the lowest adolescent HPV vaccination rates nationally. 3. Examine whether practice, patient and provider characteristics are associated with variability in the efficacy of PCOM-Virtual and PCOM-Standard. Mixed methods and the PRISM framework will facili- tate understanding how context influences the interventions' implementation to inform a User Manual. By creating an easily implementable version of the PCOM intervention, and disseminating it widely we believe we can have a substantial impact on adolescent HPV vaccination levels.





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