HPV ECHO: Increasing the Adoption of Evidence-based Communication Strategies for HPV Vaccination in Rural Primary Care Practices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months
Study Overview
Brief Summary
The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US; only 51% of 13- to 17-year-old girls and boys were up-to-date by 2018. The Announcement Approach Training is effective in increasing HPV vaccine uptake during the clinic visit by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communication like recall notifications also improve vaccination by reducing missed clinical opportunities. Although never tested to support HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) Model is a proven implementation strategy to promote capacity exchange between health care experts at academic centers and primary care providers at the front line of rural community health care. The trial will test the effectiveness of two ECHO-delivered HPV vaccination communication interventions versus control: HPV ECHO will provide Announcement Approach training, and HPV ECHO+ will provide training plus recall notices to communicate with parents who initially decline vaccination.
Detailed Description
The investigators will recruit 36 primary care clinics (family medicine and pediatric) in Pennsylvania. Eligible clinics will have at least 100 active patients, ages 11-14, in their electronic health record systems. Recruitment will target clinics in Central Pennsylvania, where most counties are designated as rural. Clinics will be randomized to one of three arms: ECHO-delivered HPV vaccine communication training using the Announcement Approach (HPV ECHO); HPV ECHO plus systems follow-up communication for parents who initially decline vaccination (HPV ECHO+); or control. Covariate-constrained randomization will be used to ensure balance among the three arms with respect to clinic size (adolescent patient population), clinic type (academic vs. non-academic), rurality, and historic adolescent HPV vaccination rates.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Clinics in cluster RCT (main study)
- •Inclusion Criteria:
- •Family medicine or pediatric clinic in Pennsylvania
- •Having at least 100 active patients, ages 11-14.
Exclusion Criteria
- •Primary care clinic outside Pennsylvania
- •Participated in HPV vaccine communication or quality improvement research either through Penn State or another institution in the last 12 months.
- •Parents in nested study survey
- •Inclusion criteria:
- •Parent or guardian of an adolescent ages 11-17
- •Adolescent has not yet started HPV vaccination
- •Adolescent receive primary care at participating clinic
- •Exclusion criteria:
- •Not the parent or guardian of an adolescent ages 11-17
- •Adolescent already initiated HPV vaccination
- •Adolescent does not receive primary care at participating clinic
Arms & Interventions
HPV ECHO
Clinics randomly assigned to this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. The intervention has a curriculum of 10 sessions focused on the evidence-based Announcement Approach. Sessions will be 60 minutes in duration and held every other weekly for 4 months at regularly scheduled times.
Intervention: Project ECHO (Other)
HPV ECHO
Clinics randomly assigned to this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. The intervention has a curriculum of 10 sessions focused on the evidence-based Announcement Approach. Sessions will be 60 minutes in duration and held every other weekly for 4 months at regularly scheduled times.
Intervention: Announcement Approach Training (Other)
HPV ECHO+
Clinics randomly assigned to this arm will receive the HPV ECHO intervention plus a systems communication strategy to deliver recall notices to parents who initially decline HPV vaccination. This arm includes 12 primary care clinics in Pennsylvania.
Intervention: Project ECHO (Other)
HPV ECHO+
Clinics randomly assigned to this arm will receive the HPV ECHO intervention plus a systems communication strategy to deliver recall notices to parents who initially decline HPV vaccination. This arm includes 12 primary care clinics in Pennsylvania.
Intervention: Announcement Approach Training (Other)
HPV ECHO+
Clinics randomly assigned to this arm will receive the HPV ECHO intervention plus a systems communication strategy to deliver recall notices to parents who initially decline HPV vaccination. This arm includes 12 primary care clinics in Pennsylvania.
Intervention: Recall notices (Other)
Control
Clinics randomly assigned to this arm will receive no ECHO interventions. This arm includes 12 primary care clinics in Pennsylvania.
Outcomes
Primary Outcomes
HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months
Time Frame: Twelve months
Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records
Secondary Outcomes
- HPV Vaccination (≥1 Dose), 11-14 Year Olds at 3 Months(Three months)
- HPV Vaccination (≥1 Dose), 11-14 Year Olds at 6 Months(Six months)
- HPV Vaccination (≥1 Dose), 11-14 Year Olds at 9 Months(Nine months)
- HPV Vaccination (Completion), 11-14 Year Olds at 3 Months(Three months)
- HPV Vaccination (Completion), 11-14 Year Olds at 6 Months(Six months)
- HPV Vaccination (Completion), 11-14 Year Olds at 9 Months(Nine months)
- HPV Vaccination (Completion), 11-14 Year Olds at 12 Months(Twelve months)
- HPV Vaccination (≥1 Dose), 15-17 Year Olds at 3 Months(Three months)
- HPV Vaccination (≥1 Dose), 15-17 Year Olds at 6 Months(Six months)
- HPV Vaccination (≥1 Dose), 15-17 Year Olds at 9 Months(Nine months)
- HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months(Twelve months)
- HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months by Sex(Twelve months)
- HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months by Sex(Twelve months)
Investigators
William Calo
Assistant Professor
Milton S. Hershey Medical Center