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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA202261 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
| American Academy of Pediatrics | OTHER |
| University of Pennsylvania | OTHER |
| National Institutes of Health (NIH) |
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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.
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 single-arm study (embedded within arm 2 of a 2-arm cluster RCT) will implement a 3-component bundle intervention together in practices that previously received standard of care. This study will test the effectiveness (and cost-effectiveness) of the bundled intervention, which trains providers in HPV vaccine communication (done through online educational modules and live office practice sessions), provides performance feedback reports (that pull from electronic health record (EHR) data, and compare participants' performance to their own previous performance and performance of others) and 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | These practices, which previously received standard of care, will receive The STOP-HPV Trial 5: Bundle Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The STOP-HPV Trial 5: Bundle Intervention | Behavioral | This intervention will implement a 3-component bundle intervention (communication skills training, performance feedback and prompts) together in practices that previously received standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Practice Inclusion Criteria:
Practice Exclusion Criteria:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Peter Szilagyi, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Academy of Pediatrics | Itasca | Illinois | 60143 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 14, 2024 | |
| Reset | Jul 9, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 14, 2024 | Jul 9, 2024 |
| NIH |
| National Cancer Institute (NCI) | NIH |
| University of Rochester | OTHER |
This single-arm study embedded within a 2-arm cluster RCT will test the difference in the rate of missed opportunities pre- and post-implementation of a 3-component intervention including communication skills, performance feedback, and prompts. These three interventions will be implemented together in practices that previously received standard of care.
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