Study Stopped
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.
Clinical Decision Support Tools to Increase Human Papillomavirus (HPV) Vaccination in Adolescents in Pharmacies
3 other identifiers
interventional
31
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
April 26, 2023
CompletedStudy Start
First participant enrolled
February 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2024
CompletedDecember 19, 2024
December 1, 2024
9 months
March 20, 2023
December 16, 2024
Conditions
Outcome Measures
Primary Outcomes (13)
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: 1. = Not at all confident 2. = Not very confident 3. = Neither (neutral) 4. = Moderately confident 5. = Completely confident And 1. = Strongly disagree 2. = Somewhat disagree 3. = Neither agree nor disagree 4. = Somewhat agree 5. = Strongly agree
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: 1. = Not at all confident 2. = Not very confident 3. = Neither (neutral) 4. = Moderately confident 5. = Completely confident And 1. = Strongly disagree 2. = Somewhat disagree 3. = Neither agree nor disagree 4. = Somewhat agree 5. = Strongly agree
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: 1. = Not at all confident 2. = Not very confident 3. = Neither (neutral) 4. = Moderately confident 5. = Completely confident And 1. = Strongly disagree 2. = Somewhat disagree 3. = Neither agree nor disagree 4. = Somewhat agree 5. = Strongly agree
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: 1. = Not at all confident 2. = Not very confident 3. = Neither (neutral) 4. = Moderately confident 5. = Completely confident And 1. = Strongly disagree 2. = Somewhat disagree 3. = Neither agree nor disagree 4. = Somewhat agree 5. = Strongly agree
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: 1. = Not at all confident 2. = Not very confident 3. = Neither (neutral) 4. = Moderately confident 5. = Completely confident And 1. = Strongly disagree 2. = Somewhat disagree 3. = Neither agree nor disagree 4. = Somewhat agree 5. = Strongly agree
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: 1. = Not at all confident 2. = Not very confident 3. = Neither (neutral) 4. = Moderately confident 5. = Completely confident And 1. = Strongly disagree 2. = Somewhat disagree 3. = Neither agree nor disagree 4. = Somewhat agree 5. = Strongly agree
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: 1. = Not at all confident 2. = Not very confident 3. = Neither (neutral) 4. = Moderately confident 5. = Completely confident And 1. = Strongly disagree 2. = Somewhat disagree 3. = Neither agree nor disagree 4. = Somewhat agree 5. = Strongly agree
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: 1. = Not at all confident 2. = Not very confident 3. = Neither (neutral) 4. = Moderately confident 5. = Completely confident And 1. = Strongly disagree 2. = Somewhat disagree 3. = Neither agree nor disagree 4. = Somewhat agree 5. = Strongly agree
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: 1. = Not at all confident 2. = Not very confident 3. = Neither (neutral) 4. = Moderately confident 5. = Completely confident And 1. = Strongly disagree 2. = Somewhat disagree 3. = Neither agree nor disagree 4. = Somewhat agree 5. = Strongly agree
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: 1. = Not at all confident 2. = Not very confident 3. = Neither (neutral) 4. = Moderately confident 5. = Completely confident And 1. = Strongly disagree 2. = Somewhat disagree 3. = Neither agree nor disagree 4. = Somewhat agree 5. = Strongly agree
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: 1. = Strongly disagree 2. = Somewhat disagree 3. = Neither agree nor disagree 4. = Somewhat agree 5. = Strongly agree And 1. Completely dissatisfied 2. Somewhat dissatisfied 3. Neither satisfied nor dissatisfied 4. Somewhat satisfied 5. Completely satisfied
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
Secondary Outcomes (1)
Rate of other adolescent vaccinations per pharmacist at each pharmacy (Aim II)
12 months prior to CDS tool implementation (baseline) up to 5 months post-implementation
Study Arms (3)
Group I (staff focus group)
EXPERIMENTALStaff participate in facilitated planning discussions to develop CDS tools on study.
Group II (staff CDS tool utilization)
EXPERIMENTALStaff receives CDS tools training and implements CDS tools to facilitate HPV vaccination on study.
Group III (parent survey)
EXPERIMENTALParents complete survey post-intervention on study.
Interventions
Utilize CDS tool
Complete survey
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Parth Shah
Fred Hutch/University of Washington Cancer Consortium
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2023
First Posted
April 26, 2023
Study Start
February 28, 2024
Primary Completion
November 22, 2024
Study Completion
November 22, 2024
Last Updated
December 19, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share