PCOM2 - The Physician Communication Intervention, Version 2.0

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HPV Infection, Preventive Health Services

Intervention / Treatment
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* Behavioral: Physician Communication 2 Virtual (PCOM2-virtual)
* Behavioral: Physician Communication Standard (PCOM-standard)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCOM Standard Arm<br>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)<br>* 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.<br>|
| Experimental: PCOM2 Virtual Arm<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunization, Provider Communication, HPV Prevention