Vaccination Clinical Trial
— STOP_HPVOfficial 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)
Verified date | June 2022 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 24 |
Est. completion date | August 9, 2022 |
Est. primary completion date | August 9, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 17 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | American Academy of Pediatrics | Itasca | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | American Academy of Pediatrics, Children's Hospital of Philadelphia, National Cancer Institute (NCI), National Institutes of Health (NIH), University of Pennsylvania, University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the rate of missed vaccination opportunities among all clinicians | Change in the rate of missed vaccination opportunities from the 6 month bundle intervention period versus the 12 month period preceding the bundle period among all clinicians. | The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up | |
Primary | Change in the rate of missed vaccination opportunities among consenting clinicians | Change in the rate of missed vaccination opportunities from the 6 month bundle intervention period versus the 12 month period preceding the bundle period among consenting clinicians. | The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up | |
Secondary | Change in the rate of missed vaccination opportunities among all clinicians. | Change in the rate of missed vaccination opportunities among all clinicians. | From months 0 (baseline) through month 28 of study activities. Study activities were paused for a 15 month period during the pandemic. |
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