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The STOP-HPV Trial 4: Bundle Intervention

Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 4. Comparison of the Bundle (Communication Skills, Performance Feedback and Prompts) and Standard of Care

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03609242
Acronym
STOP-HPV
Enrollment
48
Registered
2018-08-01
Start date
2018-08-07
Completion date
2021-03-31
Last updated
2020-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunization, Vaccination

Keywords

HPV, Vaccination, Practice Based Intervention

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 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.

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 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.

Interventions

BEHAVIORALSTOP-HPV bundle intervention

This intervention will be the bundle (training in communication skills, with the addition of performance feedback followed by the addition of provider prompts).

Sponsors

University of California, Los Angeles
Lead SponsorOTHER
Children's Hospital of Philadelphia
CollaboratorOTHER
American Academy of Pediatrics
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH
University of Rochester
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Cluster RCT study design will test the impact of the bundle (communication still training, performance feedback and prompts) to reduce missed opportunities and raise HPV vaccine rates.

Eligibility

Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change in the rate of missed vaccination opportunities among all cliniciansMonthly from months 0 (baseline) through month 21 (end of the bundle intervention period), where month 0 is site specific and depends on completion of site staff training and readiness to proceed.Change in the rate of missed vaccination opportunities from baseline through the end of the bundle intervention period among all clinicians
Change in the rate of missed vaccination opportunities among consenting cliniciansMonthly from months 0 (baseline) through month 21 (end of the bundle intervention period), where month 0 is site specific and depends on completion of site staff training and readiness to proceed.Change in the rate of missed vaccination opportunities from baseline through the end of the bundle intervention period among consenting clinicians

Countries

United States

Contacts

Primary ContactAbigail Breck
abreck@mednet.ucla.edu1-310-825-7635
Backup ContactChristina Albertin
Christina_Albertin@URMC.Rochester.edu1-317-701-4926

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026