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

Primary Purpose

HPV Infection, Preventive Health Services

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician Communication 2 Virtual (PCOM2-virtual)
Physician Communication Standard (PCOM-standard)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HPV Infection focused on measuring Immunization, Provider Communication, HPV Prevention

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University of Colorado Anschutz Medical CampusRecruiting
  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PCOM Standard Arm

PCOM2 Virtual Arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2022
Last Updated
May 8, 2023
Sponsor
University of Colorado, Denver
Collaborators
University of Kansas Medical Center, Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT05336240
Brief Title
PCOM2 - The Physician Communication Intervention, Version 2.0
Acronym
PCOM2
Official Title
PCOM2 - The Physician Communication Intervention, Version 2.0" for "Linking the Provider Recommendation to Adolescent HPV Vaccine Uptake"
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
University of Kansas Medical Center, Children's Mercy Hospital Kansas City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection, Preventive Health Services
Keywords
Immunization, Provider Communication, HPV Prevention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Data analysts on the study team
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCOM Standard Arm
Arm Type
Active Comparator
Arm 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.
Arm Title
PCOM2 Virtual Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Physician Communication 2 Virtual (PCOM2-virtual)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physician Communication Standard (PCOM-standard)
Intervention Description
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 Information:
Title
HPV vaccination initiation status in 11-12 year olds
Description
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.
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
Secondary Outcome Measure Information:
Title
HPV series completion among 11-12 year olds
Description
Secondary outcome to assess HPV series completion among 11-12-year-olds
Time Frame
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
Title
HPV vaccination initiation status in 13-17 year olds
Description
Secondary outcome to assess "catch-up" HPV vaccine series initiation among 13-17-year-olds
Time Frame
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
Title
HPV series completion among 13-17 year olds
Description
Secondary outcome to assess "catch-up" HPV vaccine series completion among 13-17 year-olds.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Spina, MSPH
Phone
303.724.0906
Email
CHRISTINE.BABBEL@CUANSCHUTZ.EDU
First Name & Middle Initial & Last Name or Official Title & Degree
Julian Dedeaux
Email
jdedeaux@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean O'Leary, MD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Spina, MSPH
Phone
303-724-0906
Email
christine.babbel@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Sean O'Leary, MD, MPH
First Name & Middle Initial & Last Name & Degree
Gretchen Homan, MD, FAAP
Facility Name
University of Kansas Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julian Dedeaux, PhD
Phone
316-518-9657
Email
jdedeaux@kumc.edu
First Name & Middle Initial & Last Name & Degree
Gretchen Homan, MD, FAAP

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PCOM2 - The Physician Communication Intervention, Version 2.0

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