PCOM2 - The Physician Communication Intervention, Version 2.0

Not Applicable

Recruiting

• Conditions: Preventive Health Services; HPV Infection

• Registration Number: NCT05336240
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-20
• Study Start: 2023-11-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HPV vaccination initiation status in 11-12 year olds	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

University of Kansas Medical Center; 🇺🇸 Wichita, Kansas, United States