The STOP-HPV Trial 4: Bundle Intervention

University of California, Los Angeles (UCLA)

Status: Unknown

Conditions: Immunization; Vaccination

Treatments: Behavioral: STOP-HPV bundle intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03609242

R01CA202261 (U.S. NIH Grant/Contract)

4R01CA202261

Details and patient eligibility

About

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 HPV vaccine communication, performance feedback reports and provider prompts (the bundle) to reduce MOs and increase HPV vaccination rates.

Full 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 cluster randomized clinical trial will test the effectiveness (and cost-effectiveness) of a bundled intervention training providers first in HPV vaccine communication skills (done through online educational modules and live office practice sessions), with the addition of performance feedback reports (that pull from electronic health record (EHR) data, and compare participants' performance to their own previous performance and performance of others) followed by the addition of 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Intervention

Experimental group

Description:

Arm 1 will receive the STOP-HPV bundle intervention

Treatment:

Behavioral: STOP-HPV bundle intervention

Control

No Intervention group

Description:

Arm 2 will receive standard of care