Clinical trial NCT03609320: The STOP-HPV Trial 5: Single Arm Evaluation of the Bundle
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
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: 2018-08-01
Enrollment: 24
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This single-arm study embedded within a 2-arm cluster RCT will test the difference in the rate of missed opportunities pre- and post-implementation of a 3-component intervention including communication skills, performance feedback, and prompts. These three interventions will be implemented together in practices that previously received standard of care.
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 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.

Detailed description: 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.

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: The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up
measure: Change in the rate of missed vaccination opportunities among consenting clinicians
timeFrame: The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up
Secondary outcomes:
measure: Change in the rate of missed vaccination opportunities among all clinicians.
timeFrame: From months 0 (baseline) through month 28 of study activities. Study activities were paused for a 15 month period during the pandemic.
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: