HPV Vaccine Communication ECHO for Primary Care Clinics

Penn State Health

Status: Completed

Conditions: Human Papillomavirus Vaccines; Adolescent Health Services

Treatments: Other: Announcement Approach Training; Other: Project ECHO; Other: Recall notices

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04587167

R37CA253279 (U.S. NIH Grant/Contract)

STUDY00015734

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

HPV ECHO

Experimental group

Description:

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.

Treatment:

Other: Project ECHO

Other: Announcement Approach Training

HPV ECHO+

Experimental group

Description:

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.

Treatment:

Other: Recall notices

Other: Project ECHO

Other: Announcement Approach Training

Control

No Intervention group

Description:

Clinics randomly assigned to this arm will receive no ECHO interventions. This arm includes 12 primary care clinics in Pennsylvania.