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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 study is part of a series of cluster randomized clinical trials (RCTs) that will test the effectiveness (and cost-effectiveness) of the addition of prompts (period 3) to performance feedback (period 2, continued through period 3) and training providers previously received on HPV vaccine communication (period 1) to reduce MOs and increase HPV vaccination rates.
This intervention will incorporate prompts via electronic health record (EHR) (e.g. alerts in electronic charts indicating patient is due for vaccination) and study practice staff prompts (reminders from study staff that a patient is due for vaccination, e.g. placing Vaccine Information Statements (VISs) on desk) to study practitioners that encourage HPV vaccination at all visits. An initial learning module on practitioner prompts will highlight how study practices can consistently implement both EHR and staff HPV vaccination prompts at all visits. Throughout the intervention, text message mini-lessons will remind participants how to best use prompts via EHR and/or office staff to improve HPV vaccination rates. This trial focuses on study period 3 where study periods are as follows:
Period 0: Baseline period, prior to the randomization of practices into intervention arms
Period 1: Arm-1 intervention study practices receive communication skills training; Arm-2 comparison study practices provide standard of care. Period 2: Arm-1 intervention study practices add performance feedback, building upon their prior training in communication skills; Arm-2 comparison study practices continue delivering standard of care. Period 3: Arm-1 intervention study practices add prompts, building upon prior communication skills and performance feedback; Arm-2 comparison study practices continue with standard of care.
Due to the COVID-19 pandemic, an additional 15-month study period (Pause Period) was introduced between feedback (Period 2) and prompts (Period 3). No study activities were undertaken during this time.
The prompts intervention effect will be interpreted within the context of the previous periods (Periods 0, 1 and 2) and the pause period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Arm 1 will receive the STOP-HPV prompts intervention |
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| Control | No Intervention | Arm 2 will receive standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STOP-HPV prompts intervention | Behavioral | This intervention will be the addition of the prompts intervention (in the presence of communication skills training and continued performance feedback). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the rate of missed vaccination opportunities among all clinicians | Change in the rate of missed vaccination opportunities separately by dose (initial vs. subsequent) and visit type (preventive vs. acute) among all clinicians. | The 12-month portion of the pause period immediately preceding initiation of prompts and the 6-month prompts period, excluding the 4-week ramp-up. |
| Change in the rate of missed vaccination opportunities among consenting clinicians | Change in the rate of missed vaccination opportunities separately by dose (initial vs. subsequent) and visit type (preventive vs. acute) among consenting clinicians | The 12-month portion of the pause period immediately preceding initiation of prompts and the 6-month prompts period, excluding the 4-week ramp-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the rate of missed vaccination opportunities among clinicians, excluding practices that failed to meet inclusion criteria throughout the study period. | Change in the rate of missed vaccination opportunities separately by dose (initial vs. subsequent) and visit type (preventive vs. acute) excluding practices that failed to meet inclusion criteria throughout the study period. | The 12-month portion of the pause period immediately preceding initiation of prompts and the 6-month prompts period, excluding the 4-week ramp-up |
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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 |
RCT study design will test the impact of the prompts intervention to reduce missed opportunities and raise HPV vaccine rates.
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