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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to enhance how clinics communicate about and administer the HPV vaccine, which prevents certain cancers caused by the human papillomavirus. Some clinics will receive communication training, while others will also receive tools to optimize their use of standing orders, which are pre-set guidelines for vaccine administration. Clinics that provide the HPV vaccine to children aged 9-12 and have a vaccination rate below 72% may be suitable candidates. The goal is to determine if these strategies can boost vaccination rates in these clinics. As an unphased trial, this study offers a unique opportunity to contribute to improving public health strategies and increasing vaccination rates.

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 prior data suggests that these communication training strategies are safe?

Research has shown that training healthcare providers to communicate better is generally safe and increases HPV vaccination rates. One study found that this training boosted vaccination rates by an average of 5.2%, indicating that the training is both safe and effective.

The impact of adding standing orders to communication training is less clear. Standing orders are pre-approved steps for certain medical tasks and are believed to increase vaccination rates. However, the readiness of clinical staff to use them has not been extensively studied. Despite this, no evidence suggests any risk or harm from using these standing orders.

Overall, both the communication training and the approach with standing orders are well-received, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they aim to enhance the effectiveness of HPV vaccination communication strategies. Unlike standard practices that rely mainly on general information sharing, the Announcement Approach Training (AAT) specifically focuses on improving how staff communicate about the HPV vaccine, potentially increasing vaccination rates. Additionally, the enhancement with standing orders optimization empowers clinic staff to streamline vaccine administration processes, making vaccination easier and more efficient. By refining communication and operational strategies, these interventions could substantially increase HPV vaccine uptake and improve public health outcomes.

What evidence suggests that this trial's treatments could be effective for optimizing HPV vaccination?

This trial compares two strategies to optimize HPV vaccination rates. One arm involves HPV vaccine communication training, which studies have shown can increase vaccination rates. For instance, one study found that this training boosted rates by an average of 5.2%, while another showed an increase of 11.7 to 13.0 percentage points during clinic visits.

The other arm combines communication training with standing orders optimization. Standing orders enable nurses or other staff to administer vaccines without immediate doctor approval. Research suggests that this combination can lead to even higher HPV vaccination rates. ^{1 2 3 6 7}

Who Is on the Research Team?

Noel T Brewer, PhD

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

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.

Clinical staff not completing the follow-up survey

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11209355/

Clinician Communication Training to Increase Human ... Our findings indicated that clinician communication training could enhance vaccination uptake rates by an average of 5.2%.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06926062

Interpersonal Communication Training and Vaccination ... Interpersonal communication training and vaccination workflow training alone or in combination may improve communication and recommendations for HPV vaccination ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9535352/

Coaching and Communication Training for HPV Vaccination Effect of a health care professional communication training intervention on adolescent human papillomavirus vaccination a cluster randomized clinical trial.

4. stacks.cdc.gov stacks.cdc.gov/view/cdc/121270/cdc_121270_DS1.pdf

Provider Communication, Prompts, and Feedback to ... Captured HPV vaccination rates improved at both well-child and other visits (by 11.7 and 13.0 percentage points, respectively). CONCLUSIONS: A bundled ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S009174352500091X

A scoping review of pediatric healthcare provider HPV ... The aim was to systematically analyze scientific literature assessing the use of implementation outcomes and behavior change theories to evaluate communication ...

6. mdpi.com mdpi.com/2076-393X/12/6/611

Clinician Communication Training to Increase Human ... Our findings indicated that clinician communication training could enhance vaccination uptake rates by an average of 5.2%. Specifically, presumptive ...

7. publications.aap.org publications.aap.org/pediatrics/article/155/2/e2024068145/200551/A-Bundled-Practice-Based-Intervention-to-Increase

Bundled Intervention to Increase HPV Vaccination | Pediatrics The current evidence shows communication training to be the most effective intervention studied for adolescent HPV vaccination, so it should be ...