Clinical Decision Support Tools to Increase Human Papillomavirus (HPV) Vaccination in Adolescents in Pharmacies

Not Applicable

Terminated

• Conditions: Human Papillomavirus-Related Carcinoma
• Interventions: Other: Educational Activity; Other: Discussion; Other: Survey Administration; Behavioral: Healthcare Activity

• Registration Number: NCT05831540
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

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 Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-26
• Study Start: 2024-02-28
• Primary Completion: 2024-11-22
• Study Completion: 2024-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group I (staff focus group)	Survey Administration	Staff participate in facilitated planning discussions to develop CDS tools on study.
Group II (staff CDS tool utilization)	Educational Activity	Staff receives CDS tools training and implements CDS tools to facilitate HPV vaccination on study.
Group III (parent survey)	Survey Administration	Parents complete survey post-intervention on study.
Group I (staff focus group)	Discussion	Staff participate in facilitated planning discussions to develop CDS tools on study.
Group II (staff CDS tool utilization)	Healthcare Activity	Staff receives CDS tools training and implements CDS tools to facilitate HPV vaccination on study.
Group II (staff CDS tool utilization)	Survey Administration	Staff receives CDS tools training and implements CDS tools to facilitate HPV vaccination on study.

Primary Outcome Measures

Name	Time	Method
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)	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.
Parents' experience Survey (Aim II)	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: 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
Acceptability of CDS tools: Pharmacy staff (Aim II)	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: 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
Appropriateness of CDS tools: Pharmacy staff (Aim II)	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: 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
Feasibility of CDS tools: Pharmacy staff (Aim II)	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: 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
Change in Acceptability of pharmacy-based HPV vaccination: Pharmacy staff (Aim II)	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: 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
Appropriateness of pharmacy-based HPV vaccination: Pharmacy staff (Aim II)	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: 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
Feasibility of pharmacy-based HPV vaccination: Pharmacy staff (Aim II)	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: 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
Feasibility of pharmacy-based HPV vaccination: Parents (Aim II)	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: 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
Acceptability of pharmacy-based HPV vaccination: Parents (Aim II)	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: 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
Appropriateness of pharmacy-based HPV vaccination: Parents (Aim II)	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: 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
Usability of CDS tools: Pharmacy staff (Aim II)	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: 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
HPV vaccination rate per pharmacist at each pharmacy (Aim II)	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.

Secondary Outcome Measures

Name	Time	Method
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	Outcomes of implementation analyzed using nonparametric tests appropriate for small sample statistics, like Wilcoxon sign-rank test.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States