PCOM2 - The Physician Communication Intervention, Version 2.0

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: HPV Infection; Preventive Health Services

Treatments: Behavioral: Physician Communication Standard (PCOM-standard); Behavioral: Physician Communication 2 Virtual (PCOM2-virtual)

Study type: Interventional

Funder types: Other

Identifiers

NCT05336240

21-4870

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 9 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

PCOM Standard Arm

Active Comparator group

Description:

Providers in participating in the PCOM-standard intervention will be trained on optimizing an in-person provider communication technique about HPV vaccination by training primary care providers in a 2-step verbal communication process: 1) to start the HPV vaccine discussion using a "presumptive" format, and 2) to use motivational interviewing (MI) techniques to address parental vaccine hesitancy.

Treatment:

Behavioral: Physician Communication Standard (PCOM-standard)

PCOM2 Virtual Arm

Experimental group

Description:

Providers participating in the PCOM2-virtual arm will receive training on this communication method through an adapted virtual model of PCOM-standard. PCOM2-Virtual intervention will result in 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. PCOM-Virtual arm will then be compared to that of the original PCOM-standard intervention in its efficacy for increasing HPV vaccination among adolescents.

Treatment:

Behavioral: Physician Communication 2 Virtual (PCOM2-virtual)