Clinical trial NCT03599557: The STOP-HPV Trial 1: Communication Intervention
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization
Vaccination
Keywords: HPV
Vaccination
Practice based intervention
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: American Academy of Pediatrics
name: University of Pennsylvania
name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: University of Rochester
First posted: 2018-07-26
Enrollment: 48
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will use a cluster RCT study design to test the impact of the communication intervention to reduce missed opportunities (MOs) and raise HPV vaccine rates
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in the Rate of Missed Vaccination Opportunities Among All Clinicians
timeFrame: Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period).
measure: Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians
timeFrame: Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period).
Secondary outcomes:
Other outcomes:
Locations:
city: Itasca
country: United States
facility: American Academy of Pediatrics
state: Illinois
Study officials:
affiliation: University of California, Los Angeles
name: Peter Szilagyi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fiks AG, Hannan C, Localio R, Kelly MK, Stephens-Shields AJ, Grundmeier RW, Shone LP, Steffes J, Breck A, Wright M, Rand CM, Albertin C, Humiston SG, McFarland G, Abney DE, Szilagyi PG. HPV Vaccinations at Acute Visits and Subsequent Adolescent Preventive Visits. Pediatrics. 2022 Nov 1;150(5):e2022058188. doi: 10.1542/peds.2022-058188. No abstract available.
citation: Szilagyi PG, Humiston SG, Stephens-Shields AJ, Localio R, Breck A, Kelly MK, Wright M, Grundmeier RW, Albertin C, Shone LP, Steffes J, Rand CM, Hannan C, Abney DE, McFarland G, Kominski GF, Seixas BV, Fiks AG. Effect of Training Pediatric Clinicians in Human Papillomavirus Communication Strategies on Human Papillomavirus Vaccination Rates: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2021 Sep 1;175(9):901-910. doi: 10.1001/jamapediatrics.2021.0766.