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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 cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of training providers on HPV vaccine communication to reduce MOs and increase HPV vaccination rates.
As highlighted by NCI, low HPV vaccination rates represent a major lost opportunity for population-wide cancer prevention. Pediatric primary care office visits are the main site for HPV vaccination, yet many missed opportunities (MOs) for vaccination occur in primary care and contribute to low vaccination rates. MOs are office visits during which a patient is eligible for a vaccine, but does not receive it. Many factors cause MOs - provider factors (e.g., time-constrained visits, lack of communication skills, and giving vaccinations only at preventive visits) and parent factors (e.g., vaccine hesitancy). This cluster randomized clinical trial will test the effectiveness (and cost-effectiveness) of training providers in HPV vaccine communication to reduce MOs and increase HPV vaccination rates. This training will be done through online educational modules (sent via text or email), weekly mini lessons and live office practice sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Arm 1 will receive the STOP-HPV communication 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 communication intervention | Behavioral | This intervention will be communication skills training. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Rate of Missed Vaccination Opportunities Among All Clinicians | The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices, regardless of whether they received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given. | Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period). |
| Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians | The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices who received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given. | Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period). |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36205071 | Derived | Fiks AG, Hannan C, Localio R, Kelly MK, Stephens-Shields AJ, Grundmeier RW, Shone LP, Steffes J, Breck A, Wright M, Rand CM, Albertin C, Humiston SG, McFarland G, Abney DE, Szilagyi PG. HPV Vaccinations at Acute Visits and Subsequent Adolescent Preventive Visits. Pediatrics. 2022 Nov 1;150(5):e2022058188. doi: 10.1542/peds.2022-058188. No abstract available. | |
| 34028494 | Derived | Szilagyi PG, Humiston SG, Stephens-Shields AJ, Localio R, Breck A, Kelly MK, Wright M, Grundmeier RW, Albertin C, Shone LP, Steffes J, Rand CM, Hannan C, Abney DE, McFarland G, Kominski GF, Seixas BV, Fiks AG. Effect of Training Pediatric Clinicians in Human Papillomavirus Communication Strategies on Human Papillomavirus Vaccination Rates: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2021 Sep 1;175(9):901-910. doi: 10.1001/jamapediatrics.2021.0766. |
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The unit of randomization in this cluster randomized design is the practice. Eligible patients of the practices had at least one visit in the baseline and/or communication period in this cluster-randomized design (overlap between periods is possible).
Practices were recruited through the American Academy of Pediatrics' PROS (Pediatric Research in Office Settings) Network. Practices were the unit of randomization (48 practices total- 24 randomized into each arm).
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Arm 1 will receive the STOP-HPV communication intervention STOP-HPV communication intervention: This intervention will be communication skills training. |
| FG001 | Control | Arm 2 will receive standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Period (12 Months) |
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| Communication Intervention (6 Months) |
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The Overall Number of Baseline Participants includes the number of individuals, but from 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Arm 1 will receive the STOP-HPV communication intervention STOP-HPV communication intervention: This intervention will be communication skills training. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Rate of Missed Vaccination Opportunities Among All Clinicians | The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices, regardless of whether they received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given. | The Overall Number Participants analyzed is the number of unique patients with one or more visits to their practice (regardless of whether HPV vaccine was due) a study period - the Baseline Period (12 months) and the Communication Intervention Period (6 months). The number of units analyzed, serving as the denominator, is the number of eligible visits (visits where a child is due for HPV vaccine). The number of these visits where the vaccine was not given at the eligible visit is the numerator. | Posted | Count of Units | Eligible visits (due for vaccine) | Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period). | Eligible visits (due for vaccine) | Eligible visits (due for vaccine) |
Adverse Events were not collected. This was not a drug/device trial, but a trial assessing the impact of provider education on missed opportunity rates.
Adverse Events were not collected. This was not a drug/device trial, but a trial assessing the impact of provider education on missed opportunity rates.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Arm 1 will receive the STOP-HPV communication intervention STOP-HPV communication intervention: This intervention will be communication skills training. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | University of California, Los Angeles | (310) 206-6328 | pszilagyi@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2018 | Jun 14, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2018 | Jun 14, 2024 | ICF_001.pdf |
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| NIH |
| National Cancer Institute (NCI) | NIH |
| University of Rochester | OTHER |
This study will use a cluster RCT study design to test the impact of the communication intervention to reduce missed opportunities (MOs) and raise HPV vaccine rates
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| NOT COMPLETED |
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Arm 2 will receive standard of care
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
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| Sex/Gender, Customized | The Overall Number of Baseline Participants includes the number of individuals, but from 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had one or more visits to their practice in either or both periods. | Participants in the baseline analysis population included the number of adolescents of the randomized practices who were aged 11-17 years with an eligible visit (HPV vaccine due), but from 2 separate time periods- the Baseline Period (12 mo) and Communication Intervention Period (6 mo). In this cluster-randomized design, participants could have had a visit in either or both periods. The sum of the two periods will equal the Overall Number of Baseline Participants provided above. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | The Overall Number of Baseline Participants includes the number of unique participants, but in 2 separate time periods- the Baseline Period (12 months) and the Communication Intervention Period (6 months). In this cluster-randomized design, participants could have had a visit in either or both periods. | Count of Participants | Participants |
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| Primary | Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians | The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices who received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given. | The unique children who made a visit (not just an HPV eligible visit) in either the baseline period (12 month) and/or the communication intervention period (6 month) to a clinician who consented to receive online training. Because the missed opportunity rate is a visit-based outcome, the overall number of units analyzed is the number of HPV eligible visits made in the two time periods and the count of units below is the number of visits where an HPV vaccination was not given in each period | Posted | Count of Units | Eligible visits (HPV due) | Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period). | Eligible visits (HPV due) | Eligible visits (HPV due) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control | Arm 2 will receive standard of care | 0 | 0 | 0 | 0 | 0 | 0 |
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| Missing |
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| Female |
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| Missing |
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| Asian or Pacific Islander |
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| American Indiana/Alaskan Native |
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| Multiracial group |
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| Other |
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| Missing data |
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| African American |
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| Asian or Pacific Islander |
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| American Indiana/Alaskan Native |
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| Multiracial group |
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| Other |
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| Missing data |
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| Communication Intervention Period |
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