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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA241518-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| University of Minnesota | OTHER |
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to examine the feasibility of using Checkup Coach, a mobile coaching intervention, to improve the way that primary care providers recommend HPV vaccination to adolescent patients and their parents. To conduct this feasibility study, the investigators will deliver the Checkup Coach intervention to 20 Kaiser Permanente Washington primary care providers who routinely recommend HPV vaccine to adolescent patients. The investigators will use a single-arm, pre-post design. Participating primary care providers will attend a 1-hour virtual communication workshop and then use a mobile phone app to receive additional coaching for 12 weeks. Providers will complete surveys at three time points: before the communication workshop, immediately after the workshop, and at 12-week follow-up. Surveys will assess changes in providers' self-reported HPV vaccine recommendation practices and beliefs about HPV vaccine and also acceptability of the intervention. The investigators hypothesizes that providers' HPV vaccine communication will improve between baseline and 12-week follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary care providers | Experimental | Providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QI coaching intervention | Behavioral | The intervention consists of two main components: a webinar communication workshop and use of the Checkup Coach mobile app. The Checkup Coach intervention begins with a brief (<1 hour), communication training workshop that reviews evidence on HPV vaccination, models guideline-consistent recommendations, trains providers to address parent concerns, and facilitates discussion of shared goals for improving. Next, providers are invited to download and use the Checkup coach mobile app at their discretion for the 12-week study period. Providers complete in-app self-assessments and receive tailored feedback about their HPV vaccine recommendation quality, progress toward improving recommendation practices, a dashboard of aggregate HPV vaccination coverage for patients in their clinic, and tips for addressing parents' concerns about HPV vaccination every time they use the app. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HPV Vaccine Recommendation Quality Score | The change in providers' mean composite score on a 5-item index of self-reported use of HPV vaccine communication practices with scores ranging from 5-25 (5 indicating the lowest quality score to 25 indicating the highest quality score). | Baseline, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa B Gilkey, PhD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98101 | United States |
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Providers were eligible and worked in clinics that agreed to participate in the study.
Providers who treat adolescent patients in participating Kaiser Permanente Washington primary care clinics in the Puget Sound and Spokane region. 21 participants consented, with 19 completing the study and 2 not completing the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Care Providers | Providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices. QI coaching intervention: The intervention consists of two main components: a webinar communication workshop and use of the Checkup Coach mobile app. The Checkup Coach intervention begins with a brief (<1 hour), communication training workshop that reviews evidence on HPV vaccination, models guideline-consistent recommendations, trains providers to address parent concerns, and facilitates discussion of shared goals for improving. Next, providers are invited to download and use the Checkup coach mobile app at their discretion for the 12-week study period. Providers complete in-app self-assessments and receive tailored feedback about their HPV vaccine recommendation quality, progress toward improving recommendation practices, a dashboard of aggregate HPV vaccination coverage for patients in their clinic, and tips for addressing parents' concerns about HPV vaccination every time they use the app. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Care Providers | Providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices. QI coaching intervention: The intervention consists of two main components: a webinar communication workshop and use of the Checkup Coach mobile app. The Checkup Coach intervention begins with a brief (<1 hour), communication training workshop that reviews evidence on HPV vaccination, models guideline-consistent recommendations, trains providers to address parent concerns, and facilitates discussion of shared goals for improving. Next, providers are invited to download and use the Checkup coach mobile app at their discretion for the 12-week study period. Providers complete in-app self-assessments and receive tailored feedback about their HPV vaccine recommendation quality, progress toward improving recommendation practices, a dashboard of aggregate HPV vaccination coverage for patients in their clinic, and tips for addressing parents' concerns about HPV vaccination every time they use the app. |
| Units | Counts |
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| 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 HPV Vaccine Recommendation Quality Score | The change in providers' mean composite score on a 5-item index of self-reported use of HPV vaccine communication practices with scores ranging from 5-25 (5 indicating the lowest quality score to 25 indicating the highest quality score). | Primary care providers who participated in the Checkup Coach QI workshop and who completed data collection at all three time points | Posted | Mean | Full Range | score | Baseline, 12 weeks |
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Adverse even data was not collected because it was a one time educational training and mobile phone educational intervention to use at participants' discretion. This was for a quality improvement project and did not pose any risk to participants.
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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 | Experimental: Primary Care Providers | Providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices. Adverse events were not collected. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Gilkey, PhD | University of North Carolina at Chapel Hill | 919-966-8650 | gilkey@email.unc.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 | May 23, 2022 | Jul 7, 2022 | Prot_SAP_000.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mean recommendation quality score | Providers' mean composite score on a 5-item index of self-reported use of HPV vaccine communication practices with scores ranging from 5-25 (5 indicating the lowest quality score to 25 indicating the highest quality score). | Only participants who completed all parts of the intervention and follow-up were included in analyses | Mean | Full Range | units on a scale |
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