The STOP-HPV Trial 5: Single Arm Evaluation of the Bundle



Status:Recruiting
Conditions:Vaccines
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:11 - 17
Updated:9/15/2018
Start Date:August 7, 2018
End Date:February 2021
Contact:Abigail Breck
Email:abreck@mednet.ucla.edu
Phone:1-310-825-7635

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Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 5. Single Arm Evaluation of the Bundle (Communication Skills, Performance Feedback and Prompts)

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 single-arm study (embedded within arm 2 of a 2-arm cluster randomized
clinical trial (RCT)) will test the effectiveness (and cost-effectiveness) of a bundled
intervention (HPV vaccine communication, performance feedback reports and provider prompts),
in practices that previously received standard of care, to reduce MOs and increase HPV
vaccination rates.

HPV vaccine rates remain lower than rates for other adolescent vaccines. Missed opportunities
(MOs) are healthcare visits during which a patient is eligible, but does not receive a
vaccine. MOs for vaccination contribute strongly to low HPV vaccination rates. This
single-arm study (embedded within arm 2 of a 2-arm cluster RCT) will implement a 3-component
bundle intervention together in practices that previously received standard of care. This
study will test the effectiveness (and cost-effectiveness) of the bundled intervention, which
trains providers in HPV vaccine communication (done through online educational modules and
live office practice sessions), provides performance feedback reports (that pull from
electronic health record (EHR) data, and compare participants' performance to their own
previous performance and performance of others) and provider prompts (via EHR and also office
staff prompts, e.g., placing Vaccine Information Statements (VISs) on desk) to reduce MOs and
increase HPV vaccination rates. Throughout the intervention participants will also receive
weekly text message mini-lessons that will remind participants of the project.

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).
We found this trial at
1
site
345 Park Boulevard
Itasca, Illinois 60143
Phone: 630-626-6629
?
mi
from
Itasca, IL
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