The STOP-HPV Trial 1: Communication Intervention

Vaccination Clinical Trial

— STOP-HPV  

Official title:

Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 1. Comparison of Communication Skills and Standard of Care for Uptake of the HPV Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599557
• Other study ID #: 1R01CA202261
• Secondary ID: R01CA202261
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: October 21, 2019

Study information

• Verified date: November 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of training providers on HPV vaccine communication to reduce MOs and increase HPV vaccination rates.

Description:

As highlighted by NCI, low HPV vaccination rates represent a major lost opportunity for population-wide cancer prevention. Pediatric primary care office visits are the main site for HPV vaccination, yet many missed opportunities (MOs) for vaccination occur in primary care and contribute to low vaccination rates. MOs are office visits during which a patient is eligible for a vaccine, but does not receive it. Many factors cause MOs - provider factors (e.g., time-constrained visits, lack of communication skills, and giving vaccinations only at preventive visits) and parent factors (e.g., vaccine hesitancy). This cluster randomized clinical trial will test the effectiveness (and cost-effectiveness) of training providers in HPV vaccine communication to reduce MOs and increase HPV vaccination rates. This training will be done through online educational modules (sent via text or email), weekly mini lessons and live office practice sessions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 21, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

Practice Inclusion Criteria:

• The practice provides HPV vaccination services to adolescents.

• The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s).

• The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year).

• The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis).

Practice Exclusion Criteria:

• The practice plans to change EHR systems in the next three years.

• The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis).

• Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction).

Patient inclusion criteria:

-All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years.

Patient exclusion criteria:

-None apart from age of patients (above).

Related Conditions & MeSH terms

• Immunization
• Vaccination

Intervention

Behavioral:
• STOP-HPV communication intervention
This intervention will be communication skills training.

Locations

Country	Name	City	State
United States	American Academy of Pediatrics	Itasca	Illinois

Sponsors (7)

Lead Sponsor	Collaborator
University of California, Los Angeles	American Academy of Pediatrics, Children's Hospital of Philadelphia, National Cancer Institute (NCI), National Institutes of Health (NIH), University of Pennsylvania, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the rate of missed vaccination opportunities among all clinicians	Change in the rate of missed vaccination opportunities from baseline through the end of the communication intervention period among all clinicians.	Monthly from months 0 (baseline) to month 6, and also aggregated over the 6-month period from month 0, where month 0 is site specific and depends on completion of site staff training and readiness to proceed.
Primary	Change in the rate of missed vaccination opportunities among consenting clinicians	Change in the rate of missed vaccination opportunities from baseline through the end of the communication intervention period among consenting clinicians.	Monthly from months 0 (baseline) to month 6, and also aggregated over the 6-month period from month 0, where month 0 is site specific and depends on completion of site staff training and readiness to proceed.