HPV Vaccine Optimization Strategies for Human Papillomavirus

Overseen By Elizabeth Bernstein

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Hospice, Pregnancy, HPV contraindications, others

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

Compensation: Varies

Number of Visits: Unknown

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will look at the impact of optimizing human papillomavirus (HPV) vaccine standing orders. The research team will work with primary care clinics. Some clinics will receive communication training. Other clinics will receive the same training and tools for increasing the use of their standing orders.

Will I have to stop taking my current medications?

The trial does not involve individual participants taking medications, as it focuses on clinics and their staff. Therefore, there is no requirement for individuals to stop taking their current medications.

What data supports the effectiveness of the treatment Communication training for HPV vaccination?

Research in oncology shows that communication skills training for healthcare providers improves their communication abilities, increases patient satisfaction, and reduces patient anxiety. These findings suggest that similar training could enhance communication about HPV vaccination, potentially leading to better patient understanding and increased vaccination rates. ^{1 2 3 4 5}

Is communication training for HPV vaccination generally safe for humans?

Communication training programs, including those for healthcare providers, have been shown to improve communication skills and patient safety without any reported safety concerns for participants. ^{1 2 6 7 8}

Research Team

Noel T Brewer, PhD

Principal Investigator

University of North Carolina

Eligibility Criteria

This trial is for primary care clinics that vaccinate children aged 9-12 against HPV but have vaccination rates below 72%. Clinics must have standing orders for the vaccine, which they either don't use routinely or are willing to adopt. Staff must complete a follow-up survey. Children and clinics not meeting these criteria are excluded.

Inclusion Criteria

My clinic approves HPV vaccination orders but doesn't always use them or is willing to start using them for the trial.

My child is between 9-12 years old and is part of a clinic's follow-up study.

Clinics with rates of HPV vaccination (≥1 dose) below 72%, boys and girls combined

Exclusion Criteria

Clinics with rates of HPV vaccination (≥1 dose) above 72%, boys and girls combined

My clinic does not offer HPV vaccines to kids aged 9-12.

Clinics that have hosted an AAT workshop in the previous 3 years or are part of current HPV vaccine communication trainings

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinics receive communication training and tools for optimizing HPV vaccine standing orders

6 months

Training sessions and follow-up surveys

Follow-up

Clinics are monitored for changes in HPV vaccination rates and implementation of standing orders

24 months

Treatment Details

Interventions

• Communication training
• Communication training enhanced with standing orders optimization

Trial Overview The study tests whether communication training combined with optimized standing orders increases HPV vaccination rates in clinics. Some clinics will receive only training, while others will get both training and tools to improve their standing order usage.

Participant Groups

Group I: HPV vaccine communication training and standing orders optimization Experimental Treatment 1 Intervention

Staff in clinics randomized to this arm will receive the AAT and conduct a set of activities to optimize use of HPV vaccine standing orders.

Group II: HPV vaccine communication training Experimental Treatment 1 Intervention

Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A systematic review of 96 studies on communication training for oncology professionals highlighted that outcomes like communication confidence, observed skills, and patient satisfaction were commonly assessed, but varied widely across studies.

Experts recommend that future studies should clearly define outcomes linked to specific training objectives and assess them at multiple levels, including those of healthcare professionals, patients, and the interactions between them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and outcome measures used in evaluation of communication training in oncology - a systematic literature review, an expert workshop, and recommendations for future research. Fischer, F., Helmer, S., Rogge, A., et al.[2023]

Communication skills training programs for oncology healthcare providers significantly improve specific communication skills and provider confidence, as shown in 19 out of 21 studies reviewed.

Longer training programs, especially those including consolidation workshops, are more effective in maintaining these skills over time, highlighting the importance of comprehensive training in enhancing patient-provider interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication in oncology care: the effectiveness of skills training workshops for healthcare providers. Kennedy Sheldon, L.[2022]

A two-day communication skills training (CST) workshop for 20 gynecologic oncology providers led to significant improvements in their preparedness to handle challenging communication tasks, with all participants reporting enhancement in at least one area.

One month after the workshop, 86% of participants regularly applied their new skills in practice, and over 75% noted that the training had a practice-changing impact, indicating the effectiveness and importance of CST in gynecologic oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gynecologic oncology providers endorse practice-changing impact of communication skills training. Lefkowits, C., Bevis, K., Carey, EC., et al.[2019]

Effective communication between healthcare professionals and cancer patients is crucial for improving patient experiences during their treatment journey.

Training in communication skills for oncology professionals has been shown to enhance their ability to support patients, as highlighted in the systematic review and meta-analysis by Barth and Lannen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for communication skills training in oncology. Hilaire, DM.[2021]

Many patients leave medical consultations without a clear understanding of their diagnosis and treatment plans, highlighting a significant gap in communication between healthcare professionals and patients.

Training healthcare professionals in effective communication skills has been shown to improve patient understanding and outcomes, but more research is needed to demonstrate the long-term benefits of such training in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current concepts of communication skills training in oncology. Fallowfield, L., Jenkins, V.[2019]

A communication training program was developed and tested with 42 surgical oncology staff members, leading to significant improvements in their ability to communicate patient safety concerns, as evidenced by a statistical analysis (P = .009).

Focus groups with 34 staff members identified key factors affecting communication, such as hierarchy, fear of retaliation, and time pressure, which informed the training program's development and highlighted the importance of addressing these challenges in the operating room.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Communication Training Program to Encourage Speaking-Up Behavior in Surgical Oncology. D'Agostino, TA., Bialer, PA., Walters, CB., et al.[2018]

The Medical Team Training (MTT) program, inspired by aviation crew resource management, was implemented in 43 VA medical centers to enhance communication among healthcare professionals, addressing the critical issue of communication failures that contribute to 75% of adverse events in healthcare.

The program included interactive learning sessions and practical projects, such as multidisciplinary rounds and preoperative briefings, which aimed to improve patient care outcomes by fostering better teamwork and communication in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical team training: applying crew resource management in the Veterans Health Administration. Dunn, EJ., Mills, PD., Neily, J., et al.[2019]

Effective communication in public health is crucial for patient safety, as it helps reduce adverse events caused by misinformation or lack of education.

The paper presents a design for multilingual educational tools aimed at improving adherence to pediatric vaccination, thereby minimizing risks associated with information failures in a multicultural context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effective Communication in Vaccination Program as a Patient Safety tool: the Lombardy region experience]. Amato, S., Aquino, I., Basilico, O., et al.[2012]

References

1. England pubmed.ncbi.nlm.nih.gov

Outcomes and outcome measures used in evaluation of communication training in oncology - a systematic literature review, an expert workshop, and recommendations for future research. [2023]

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

Communication in oncology care: the effectiveness of skills training workshops for healthcare providers. [2022]

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

Gynecologic oncology providers endorse practice-changing impact of communication skills training. [2019]

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

The need for communication skills training in oncology. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Current concepts of communication skills training in oncology. [2019]

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

A Communication Training Program to Encourage Speaking-Up Behavior in Surgical Oncology. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Medical team training: applying crew resource management in the Veterans Health Administration. [2019]

8. Italy pubmed.ncbi.nlm.nih.gov

[The effective Communication in Vaccination Program as a Patient Safety tool: the Lombardy region experience]. [2012]