PCOM2 - The Physician Communication Intervention, Version 2.0
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-17
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Physician Communication 2 Virtual (PCOM2-virtual)
BehavioralThe 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)
BehavioralThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: PCOM Standard ArmActive comparator 1 intervention
Group B: PCOM2 Virtual ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 periodSecondary outcomes
1
HPV series completion among 11-12 year olds
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 period2
HPV vaccination initiation status in 13-17 year olds
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 period3
HPV series completion among 13-17 year olds
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 periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
University of Kansas Medical Center
Collaborator
San Diego State University
Collaborator
Source ClinicalTrials.gov