- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05831540
Clinical Decision Support Tools to Increase Human Papillomavirus (HPV) Vaccination in Adolescents in Pharmacies
Clinical Decision Support Tools to Increase HPV Vaccination in Pharmacies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Parth Shah
- Phone Number: 206-667-6120
- Email: pshah@fredhutch.org
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Recruiting
- Fred Hutch/University of Washington Cancer Consortium
-
Contact:
- Parth Shah
- Phone Number: 206-667-6120
- Email: pshah@fredhutch.org
-
Principal Investigator:
- Parth Shah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- AIM I: >= 18 years
- AIM I: Pharmacy staff: Employed at the partnering community pharmacies in Washington state
- AIM I: Scientific Technologies Corportation (STC)Health staff: Employed at STCHealth
- AIM I: PioneerRx staff: Employed at PioneerRx
- AIM II: >= 18 years
- AIM II: Parents: English speaking parent or guardian of at least one child, ages 9-17, living in Washington state and obtained an HPV vaccination for their child at a participating pharmacy and have access to a telephone or computer with internet access.
- AIM II: Pharmacy staff: Employed at community pharmacies recruited into the study located in Washington state
Exclusion Criteria:
- Pharmacy staff: Floaters/per diem. Those who object to having the focus group discussions audio recorded. Those who object to participating in implementation evaluation surveys
- STCHealth staff: Those who object to having the focus group discussions audio recorded
- PioneerRx staff: Those who object to having the focus group discussions audio recorded
- Parents: Those who decline to provide feedback on their experiences with getting their children vaccinated at the pharmacy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I (staff focus group)
Staff participate in facilitated planning discussions to develop CDS tools on study.
|
Complete survey
Participate in focus group
Other Names:
|
Experimental: Group II (staff CDS tool utilization)
Staff receives CDS tools training and implements CDS tools to facilitate HPV vaccination on study.
|
Complete survey
Undergo training to use CDS tool
Utilize CDS tool
Other Names:
|
Experimental: Group III (parent survey)
Parents complete survey post-intervention on study.
|
Complete survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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)
Time Frame: Up to 6 months
|
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)
Time Frame: Post-implementation of CDS tools survey (at Months 11-12)
|
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)
Time Frame: Pre-implementation of CDS Tools survey (at Months 4-5) and post- test implementation survey (at Months 11-12)
|
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)
Time Frame: Post-vaccination experience survey (at Months 8-12)
|
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
|
Post-vaccination experience survey (at Months 8-12)
|
Appropriateness of CDS tools: Pharmacy staff (Aim II)
Time Frame: Post-test implementation survey (at Months 11-12)
|
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)
Time Frame: Pre-test implementation survey (at Months 4-5) and post- test implementation survey (at Months 11-12)
|
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)
Time Frame: Post-vaccination experience survey (at Months 8-12)
|
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)
Time Frame: Post-test implementation survey (at Months 11-12)
|
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)
Time Frame: Pre-test implementation survey (at Months 4-5) and post- test implementation survey (at Months 11-12)
|
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)
Time Frame: Post-vaccination experience survey (at Months 8-12)
|
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)
Time Frame: Post-test implementation survey (at Months 11-12)
|
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)
Time Frame: Post-implementation of CDS tools up to 12 months
|
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
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HPV vaccination rate per pharmacist at each pharmacy (Aim II)
Time Frame: 12 months prior to CDS tool implementation (baseline) up to 5 months post-implementation
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Outcomes of implementation analyzed using nonparametric tests appropriate for small sample statistics, like Wilcoxon sign-rank test.
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12 months prior to CDS tool implementation (baseline) up to 5 months post-implementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of other adolescent vaccinations per pharmacist at each pharmacy (Aim II)
Time Frame: 12 months prior to CDS tool implementation (baseline) up to 5 months post-implementation
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Parth Shah, Fred Hutch/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RG1122655
- NCI-2023-01989 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 11086 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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