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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-01989 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 11086 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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This study has been terminated due to the conclusion of funding. We were able to collect data on primary outcomes through pharmacy staff, but due to recruitment challenges were not able to complete secondary outcome recruitment.
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This clinical trial develops and tests how well a clinical decision support (CDS) tool works to increase human papillomavirus (HPV) vaccination of children between the age of 9-17 (adolescents) in pharmacies. HPV vaccination rate in eligible adolescents remains low even though over 90% of the cancers in adults caused by HPV can be prevented by the HPV vaccine. The National Vaccine Advisory Committee recommends HPV vaccinations to be given in pharmacies to increase access to vaccines, but pharmacy processes and lack of awareness of the service among parents impact the use of local pharmacies for HPV vaccinations. Using a focus group may be an effective method to develop a CDS tool and create a process that may be more convenient for parents to get their adolescent's vaccine at their local pharmacy. A CDS tool may make it easier to obtain HPV vaccines, and as a result increase the adolescent HPV vaccination rate and reduce the incidence of cancer caused by HPV.
OUTLINE: Participants are assigned to 1 of 3 groups.
Group I: Staff participate in facilitated planning discussions to develop CDS tools on study. (Aim I)
Group II: Staff receives CDS tools training and implements CDS tools to facilitate HPV vaccination on study. (Aim II)
Group III: Parents complete survey post-intervention on study. (Aim II)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (staff focus group) | Experimental | Staff participate in facilitated planning discussions to develop CDS tools on study. |
|
| Group II (staff CDS tool utilization) | Experimental | Staff receives CDS tools training and implements CDS tools to facilitate HPV vaccination on study. |
|
| Group III (parent survey) | Experimental | Parents complete survey post-intervention on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discussion | Other | Participate in focus group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development/refinement of the CDS tools to support and guide any adaptations to the pharmacy staff's vaccination workflow to improve vaccine delivery. (Aim 1) | The research team will analyze the collected qualitative data using framework-guided rapid analyses described by Gale et al. The qualitative data will be used to direct and document the development and refinement process for the CDS tools to support HPV vaccination and to guide any adaptations to the pharmacy staff's vaccination workflow to improve their delivery of HPV vaccine. Adaptations made to a pharmacy's vaccination workflow will be methodically documented using Stirman's Taxonomy of Adaptation Characteristics. | Up to 6 months |
| Acceptability of CDS tools: Pharmacy staff (Aim II) | Will use validated survey measure to assess pharmacy staff's report of the acceptability of the CDS tools to support HPV Vaccination. Survey responses will include 5-point scales:
And
| Post-implementation of CDS tools survey (at Months 11-12) |
| Change in Acceptability of pharmacy-based HPV vaccination: Pharmacy staff (Aim II) | The survey will ask pharmacy staff to respond to statements designed to measure acceptability of pharmacy-based HPV vaccination. Survey responses will include 5-point scales:
And
| Pre-implementation of CDS Tools survey (at Months 4-5) and post- test implementation survey (at Months 11-12) |
| Acceptability of pharmacy-based HPV vaccination: Parents (Aim II) | The survey will ask parents to respond to statements designed to measure acceptability of their vaccine experience at the pharmacy. Survey responses will include 5-point scales:
And
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of other adolescent vaccinations per pharmacist at each pharmacy (Aim II) | Outcomes of implementation analyzed using nonparametric tests appropriate for small sample statistics, like Wilcoxon sign-rank test. | 12 months prior to CDS tool implementation (baseline) up to 5 months post-implementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parth Shah | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 6, 2024 | Nov 20, 2024 |
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| Educational Activity | Other | Undergo training to use CDS tool |
|
| Healthcare Activity | Behavioral | Utilize CDS tool |
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| Survey Administration | Other | Complete survey |
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| Post-vaccination experience survey (at Months 8-12) |
| Appropriateness of CDS tools: Pharmacy staff (Aim II) | The survey will ask pharmacy staff to respond to statements designed to measure appropriateness of the CDS tools to support HPV vaccination. Survey responses will include 5-point scales:
And
| Post-test implementation survey (at Months 11-12) |
| Appropriateness of pharmacy-based HPV vaccination: Pharmacy staff (Aim II) | The survey will ask pharmacy staff to respond to statements designed to measure appropriateness of pharmacy-based HPV vaccination. Survey responses will include 5-point scales:
And
| Pre-test implementation survey (at Months 4-5) and post- test implementation survey (at Months 11-12) |
| Appropriateness of pharmacy-based HPV vaccination: Parents (Aim II) | The survey will ask parents to respond to statements designed to measure appropriateness of their vaccine experience at the pharmacy. Survey responses will include 5-point scales:
And
| Post-vaccination experience survey (at Months 8-12) |
| Feasibility of CDS tools: Pharmacy staff (Aim II) | The survey will ask pharmacy staff to respond to statements designed to measure feasibility of the CDS tools to support HPV vaccination. Survey responses will include 5-point scales:
And
| Post-test implementation survey (at Months 11-12) |
| Feasibility of pharmacy-based HPV vaccination: Pharmacy staff (Aim II) | The survey will ask pharmacy staff to respond to statements designed to measure feasibility of pharmacy-based HPV vaccination. Survey responses will include 5-point scales:
And
| Pre-test implementation survey (at Months 4-5) and post- test implementation survey (at Months 11-12) |
| Feasibility of pharmacy-based HPV vaccination: Parents (Aim II) | The survey will ask parents to respond to statements designed to measure feasibility of their vaccine experience at the pharmacy. Survey responses will include 5-point scales:
And
| Post-vaccination experience survey (at Months 8-12) |
| Usability of CDS tools: Pharmacy staff (Aim II) | The survey will ask pharmacy staff to respond to statements designed to measure usability of the CDS tools to support HPV vaccination. Survey responses will include 5-point scales:
And
| Post-test implementation survey (at Months 11-12) |
| Parents' experience Survey (Aim II) | This is a 30-question survey asking about experience with getting child vaccinated at participating pharmacy. Survey responses will include a 5-point scales:
And
| Post-implementation of CDS tools up to 12 months |
| HPV vaccination rate per pharmacist at each pharmacy (Aim II) | Outcomes of implementation analyzed using nonparametric tests appropriate for small sample statistics, like Wilcoxon sign-rank test. | 12 months prior to CDS tool implementation (baseline) up to 5 months post-implementation |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| ID | Term |
|---|---|
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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