PCOM2 - The Physician Communication Intervention, Version 2.0 (PCOM2)

PCOM2 - The Physician Communication Intervention, Version 2.0" for "Linking the Provider Recommendation to Adolescent HPV Vaccine Uptake"

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.

Study Overview

• Status: Recruiting
• Conditions: HPV Infection; Preventive Health Services
• Intervention / Treatment: Behavioral: Physician Communication Standard (PCOM-standard); Behavioral: Physician Communication 2 Virtual (PCOM2-virtual)

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Spina, MSPH; Phone Number: 303.724.0906; Email: CHRISTINE.BABBEL@CUANSCHUTZ.EDU
• Study Contact Backup: Name: Julian Dedeaux; Email: jdedeaux@kumc.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Christine Spina, MSPH; Phone Number: 303-724-0906; Email: christine.babbel@cuanschutz.edu
      • Principal Investigator: Sean O'Leary, MD, MPH
      • Sub-Investigator: Gretchen Homan, MD, FAAP
  • Kansas
    • Wichita, Kansas, United States, 67208
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Julian Dedeaux, PhD; Phone Number: 316-518-9657; Email: jdedeaux@kumc.edu
      • Principal Investigator: Gretchen Homan, MD, FAAP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PCOM Standard Arm; 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.	Behavioral: Physician Communication Standard (PCOM-standard); The PCOM-standard intervention is based off of a provider communication training that utilizes presumptive technique when initiating the vaccine discussion followed by motivational interviewing if a parent continues to show hesitation. PCOM-standard will be conducted in-person with providers.
Experimental: PCOM2 Virtual Arm; 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.	Behavioral: Physician Communication 2 Virtual (PCOM2-virtual); The PCOM-standard intervention is based off of a provider communication training that utilizes presumptive technique when initiating the vaccine discussion followed by motivational interviewing if a parent continues to show hesitation. While this provider communication technique previously showed success in increasing HPV vaccination uptake, it is neither easy to disseminate nor sustainable due to it's nature of direct, intensive in-person training. Therefore, the intervention is to compare the standard-PCOM intervention to a new, PCOM2 intervention, that will be adapted virtually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV vaccination initiation status in 11-12 year olds	The primary outcome to be assessed in the trial is HPV vaccine series initiation among 11-12-year-olds as 11-12 year-olds are the preferred target population for HPV vaccination and the PCOM intervention had its strongest effect on series initiation rather than completion.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV series completion among 11-12 year olds	Secondary outcome to assess HPV series completion among 11-12-year-olds	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
HPV vaccination initiation status in 13-17 year olds	Secondary outcome to assess "catch-up" HPV vaccine series initiation among 13-17-year-olds	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
HPV series completion among 13-17 year olds	Secondary outcome to assess "catch-up" HPV vaccine series completion among 13-17 year-olds.	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: University of Kansas Medical Center; Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Sean O'Leary, MD, MPH, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Immunization; Provider Communication; HPV Prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Papillomavirus Infections
• Other Study ID Numbers: 21-4870

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No