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 test an online training program for healthcare providers to improve how they talk about the HPV vaccine. The goal is to increase vaccination rates among teens, reducing their risk of HPV-related cancers and diseases.

Will I have to stop taking my current medications?

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

Is the Improved Doctor-Patient Communication for HPV Vaccination intervention safe for humans?

The research articles focus on the effectiveness and acceptability of communication interventions for HPV vaccination, but they do not provide specific safety data for these interventions. However, the interventions are generally described as acceptable and feasible, suggesting no significant safety concerns were reported. ^{1 2 3 4 5}

How is the PCOM2-virtual treatment different from other treatments for improving HPV vaccination rates?

The PCOM2-virtual treatment is unique because it uses virtual communication training to enhance how doctors talk to patients about the HPV vaccine, making it more accessible and less costly than traditional in-person training methods. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment Physician Communication 2 Virtual (PCOM2-virtual) for improving doctor-patient communication about HPV vaccination?

Research shows that communication training for healthcare providers, including virtual reality and app-based interventions, can significantly increase HPV vaccination rates by improving how doctors talk to patients and parents about the vaccine. These interventions help doctors make stronger recommendations and address concerns more effectively, leading to higher acceptance and vaccination rates. ^{1 4 6 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

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]

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]

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 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]

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]

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]

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 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]

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]

Citations

1. United States 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. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Reality Curriculum on Human Papillomavirus Vaccination: A Pilot Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility of using an app-based coaching intervention to improve provider communication about HPV vaccination. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of a multi-component intervention on providers' HPV vaccine communication. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Quality of physician communication about human papillomavirus vaccine: findings from a national survey. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The implementation and acceptability of an HPV vaccination decision support system directed at both clinicians and families. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The content and context of physicians' communication with males about human papillomavirus vaccination. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Messages to Motivate Human Papillomavirus Vaccination: National Studies of Parents and Physicians. [2022]

9. Thailand pubmed.ncbi.nlm.nih.gov

HPV vaccination in Hong Kong: implications for medical education. [2017]