Improved Doctor-Patient Communication for HPV Vaccination

(PCOM2 Trial)

Recruiting at 1 trial location

Overseen By Julian Dedeaux

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Non-enrolled clinics, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance how doctors discuss the HPV vaccine with parents, potentially increasing vaccination rates and protecting against HPV-related cancers. Researchers are testing a new virtual training method for doctors, called Physician Communication 2 Virtual (PCOM2-virtual), to determine its effectiveness compared to traditional in-person communication training. Parents with children aged 9-17 who receive care at certain clinics, along with healthcare providers at these clinics, may be eligible to participate. As an unphased trial, this study provides a unique opportunity to improve healthcare communication and potentially boost vaccination rates.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these communication methods are safe for improving HPV vaccination rates?

Research has shown that the PCOM2-virtual method is promising for improving HPV vaccination rates. A similar virtual reality training program significantly increased the start of vaccinations, indicating that this approach works well.

Regarding safety, no safety concerns have been reported for these communication training programs. They offer new ways for doctors to talk to patients to help increase vaccination rates. Since this trial focuses on communication methods rather than a new drug or medical procedure, there are no typical "adverse events" to worry about.

In summary, the PCOM2-virtual program is safe because it doesn't involve any medical or physical risks. It focuses on improving how doctors communicate, so there are few safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve doctor-patient communication to boost HPV vaccination rates among adolescents. The PCOM2-virtual method is unique because it adapts the standard in-person communication model to a virtual format, making it easier for healthcare providers to implement widely through a "shelf-ready" intervention with an accompanying user manual. By comparing this virtual approach to the traditional in-person method, the trial aims to see if the virtual model is just as effective, or perhaps even more so, in overcoming parental vaccine hesitancy and increasing vaccination uptake. This could lead to more flexible and accessible vaccination communication strategies that can be integrated into various healthcare settings.

What evidence suggests that this trial's communication methods could be effective for increasing HPV vaccination rates?

Research has shown that a communication method called PCOM successfully increases HPV vaccination rates among teenagers. In an earlier study, PCOM raised vaccine start rates by 8% more than usual methods. This trial will compare two versions of the PCOM intervention: PCOM2-virtual and PCOM-standard. The online version, PCOM2-virtual, offers the same training in a more convenient way. Another similar online program, VICTORI, significantly increased vaccination rates from 54.3% to 72.4%. These results suggest that improving how doctors discuss the HPV vaccine with patients can lead to more teenagers getting vaccinated, helping protect them from diseases related to HPV. ^{1 6 7 8 9}

Who Is on the Research Team?

Sean O'Leary, MD, MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for parents with kids aged 9-17 receiving care at enrolled clinics, and for healthcare providers working at these practices. Parents without children in this age range or not attending the participating clinics, and providers outside these practices cannot join.

Inclusion Criteria

Providers: All providers at participating study practices will be eligible to participate.

I am a parent of a 9-17 year old who is receiving care at an enrolled clinic.

Exclusion Criteria

Providers: Providers who are not at participating study practices

I do not have a child aged 9-17 nor is my child receiving care at an enrolled clinic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of the PCOM-Virtual intervention using principles of Dissemination & Implementation Science

6 months

Intervention Comparison

Comparison of the efficacy of PCOM-Virtual versus PCOM-Standard in improving adolescent HPV vaccine utilization

24 months

Follow-up

Participants are monitored for HPV vaccination initiation and completion status

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Physician Communication 2 Virtual (PCOM2-virtual)
• Physician Communication Standard (PCOM-standard)

Trial Overview The study is testing two ways of talking to patients about HPV vaccines: a new virtual communication method (PCOM2-virtual) versus the standard approach (PCOM-standard). The goal is to see if the virtual version can improve vaccination rates without needing much help from research teams.

How Is the Trial Designed?

Group I: PCOM2 Virtual Arm Experimental Treatment 1 Intervention

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.

Group II: PCOM Standard Arm Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

San Diego State University

Collaborator

Trials

182

Recruited

119,000+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

Children's Mercy Hospital Kansas City

Collaborator

Trials

261

Recruited

941,000+

Published Research Related to This Trial

The Checkup Coach app-based intervention significantly improved provider communication practices regarding HPV vaccination, with high-quality recommendation practices increasing from 47% to 74% among 19 participating providers over a 3-month period.

Most providers found the app user-friendly and convenient, with 78% actively using it, suggesting that app-based training could be a feasible alternative to traditional in-person training for enhancing HPV vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using an app-based coaching intervention to improve provider communication about HPV vaccination. Grabert, BK., McRee, AL., Henrikson, NB., et al.[2023]

A virtual reality training program called VICTORI significantly improved HPV vaccination initiation rates among patients, increasing from 54.3% to 72.4% in the intervention group of physicians who participated in the training.

In contrast, the comparison group that only used a smartphone application showed no significant change in vaccination rates, highlighting the effectiveness of immersive training in enhancing physician recommendation behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Reality Curriculum on Human Papillomavirus Vaccination: A Pilot Trial. Real, FJ., Ollberding, NJ., Meisman, AR., et al.[2023]

Only 29.9% of physicians present the HPV vaccine as a routine recommendation for males aged 11-12, the target group for vaccination, indicating a need for improved communication practices.

Despite many physicians emphasizing the cancer prevention aspect of the HPV vaccine (80.0%), there are missed opportunities to discuss it during visits, particularly since over half of physicians reported that other healthcare professionals in their practice also discuss or recommend the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The content and context of physicians' communication with males about human papillomavirus vaccination. Malo, TL., Ali, KN., Sutton, SK., et al.[2021]

A national survey of 776 pediatricians and family physicians revealed that 27% do not strongly endorse the HPV vaccine, and many do not recommend it timely, with 26% for girls and 39% for boys not recommending it by the ideal ages of 11-12.

The study found that only 51% of physicians usually recommend same-day vaccination, and those who are uncomfortable discussing the vaccine or believe parents undervalue it tend to provide lower quality recommendations, contributing to under-immunization among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of physician communication about human papillomavirus vaccine: findings from a national survey. Gilkey, MB., Malo, TL., Shah, PD., et al.[2022]

A 12-month randomized controlled trial showed that healthcare providers who used a combination of communication strategies, including the presumptive approach and motivational interviewing, reported higher levels of parental acceptance of the HPV vaccine.

The intervention also led to increased vaccination rates among adolescents, highlighting the importance of effective communication in improving HPV vaccination uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining strategies for improving healthcare providers' communication about adolescent HPV vaccination: evaluation of secondary outcomes in a randomized controlled trial. Reno, JE., Thomas, J., Pyrzanowski, J., et al.[2020]

The electronic medical record (EMR)-based HPV vaccine decision support intervention was well-received by parents, with 46% recalling the reminder call, which encouraged them to seek more information and discuss the vaccine with others.

Parents whose daughters attended practices using the clinician-focused intervention were more likely to have discussions about the HPV vaccine during preventive visits, indicating that the intervention positively influenced clinician engagement and communication about vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation and acceptability of an HPV vaccination decision support system directed at both clinicians and families. Mayne, S., Karavite, D., Grundmeier, RW., et al.[2021]

A multi-component intervention, including communication training, significantly improved providers' beliefs about the HPV vaccine, with the percentage of providers considering it a key adolescent vaccine rising from 71% to 100%.

The intervention also enhanced recommendation practices, as evidenced by an increase in the use of a presumptive recommendation style from 62.5% to 79.6%, indicating a more effective approach to discussing the HPV vaccine with parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a multi-component intervention on providers' HPV vaccine communication. Perkins, RB., Banigbe, B., Fenton, AT., et al.[2021]

Physicians identified that public knowledge about HPV and cervical cancer is lacking, which hinders the promotion of HPV vaccination.

Effective promotion strategies, including strong physician recommendations, financial assistance, and government-led health education, are crucial for increasing HPV vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV vaccination in Hong Kong: implications for medical education. Chan, ZC., Chan, TS., Lam, YM., et al.[2017]

A national survey of 1,504 parents and 776 physicians identified that a strong message emphasizing the importance of the HPV vaccine for cancer prevention was persuasive for both groups, with 65% of parents and 69% of physicians supporting it.

Parents who were hesitant about vaccinating their children responded positively to messages highlighting the commonality of HPV infections, the cancers it can cause, and the vaccine's effectiveness, indicating that these messages can effectively motivate vaccination across diverse demographic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Messages to Motivate Human Papillomavirus Vaccination: National Studies of Parents and Physicians. Malo, TL., Gilkey, MB., Hall, ME., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/EaC3BhVN6USBfOMuTswDVQ/project-details/11020939

RePORT RePORTER - National Institutes of Health (NIH) | In a large, cluster-randomized trial, PCOM increased adolescent HPV vaccine initiation rates among 11-12 year olds by 8 percentage points (PP) more than ...

2. withpower.com withpower.com/trial/phase-human-papilloma-virus-hpv-7-2022-9b611

Improved Doctor-Patient Communication for HPV Vaccination A virtual reality training program called VICTORI significantly improved HPV vaccination initiation rates among patients, increasing from 54.3% to 72.4% in the ...

3. clinicaltrial.be clinicaltrial.be/en/details/17483?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

PCOM2 - The Physician Communication Intervention, ... 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02377843?cond=Human%20papillomavirus&viewType=Table&rank=10

Making Effective Human Papillomavirus (HPV) Vaccine ... This study will evaluate the effectiveness of two communication trainings to increase HPV vaccination coverage among adolescent patients. ... Change in clinician ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524000755

Effectiveness of provider communication training for ... Our overall results suggest a modest decrease in HPV vaccination prevalence immediately after a brief provider communication training with clinic-level audit ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4964733/

Provider communication about HPV vaccination Providers less often recommended HPV vaccine if they were uncomfortable discussing sex, perceived parents as hesitant, or believed patients to be low risk.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1054139X24001071

Physicians' Human Papillomavirus Vaccine ... VR demonstrated feasibility as a viable approach to observe and measure physicians' HPV vaccine communication including indicators of racially based implicit ...

8. publications.aap.org publications.aap.org/pediatrics/article/155/3/e2024066742/200812/Cost-Analysis-of-a-Scalable-Clinician

Cost Analysis of a Scalable Clinician Communication ... Online communication training reduced missed opportunities (MOs) for initial human papillomavirus (HPV) vaccination at well-child care (WCC) ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02551887

HPV Vaccination: An Investigation of Physician Reminders ... Outcome measurement. The outcome of primary interest, HPV vaccine uptake, will be recorded by having the CHICA system re-query the CHIRP system after each visit ...