Recruiting

Physician Communication

Sponsor:

University of Colorado, Denver

Code:

NCT05336240

Conditions

HPV Infection

Preventive Health Services

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

Interventions

Physician Communication 2 Virtual (PCOM2-virtual)

Physician Communication Standard (PCOM-standard)

Study Details

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.

Conditions

HPV Infection

Preventive Health Services

Study ID

NCT05336240

Start date

Nov 15, 2023

Status verified date

Aug, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • HPV vaccination initiation status in 11-12 year olds [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Christine Spina, MSPH

303.724.0906CHRISTINE.BABBEL@CUANSCHUTZ.EDU

Julian Dedeaux

jdedeaux@kumc.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Christine Spina, MSPH

303-724-0906christine.babbel@cuanschutz.edu

Principal Investigator:

Sean O'Leary, MD, MPH

University of Kansas Medical Center

Recruiting

Wichita, Kansas, United States, 67208

Contacts

Evelyn English

eenglish4@kumc.edu

Principal Investigator:

Gretchen Homan, MD, FAAP

More Information

Sponsor

University of Colorado, Denver

Last update posted

Aug 26, 2024

Last verified

Aug, 2024

Keywords

  • Immunization
  • Provider Communication
  • HPV Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-08-26.