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

Human Papillomavirus-Related Carcinoma Clinical Trial

Official title:

Clinical Decision Support Tools to Increase HPV Vaccination in Pharmacies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831540
• Other study ID #: RG1122655
• Secondary ID: NCI-2023-0198911
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Parth Shah
• Phone: 206-667-6120
• Email: pshah[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus-Related Carcinoma

Intervention

Other:
• Discussion
Participate in focus group
• Educational Activity
Undergo training to use CDS tool

Behavioral:
• Healthcare Activity
Utilize CDS tool

Other:
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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: = Not at all confident; = Not very confident; = Neither (neutral); = Moderately confident; = Completely confident; And; = Strongly disagree; = Somewhat disagree; = Neither agree nor disagree; = Somewhat agree; = Strongly agree	Post-implementation of CDS tools survey (at Months 11-12)
Primary	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: = Not at all confident; = Not very confident; = Neither (neutral); = Moderately confident; = Completely confident; And; = Strongly disagree; = Somewhat disagree; = Neither agree nor disagree; = Somewhat agree; = Strongly agree	Pre-implementation of CDS Tools survey (at Months 4-5) and post- test implementation survey (at Months 11-12)
Primary	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: = Not at all confident; = Not very confident; = Neither (neutral); = Moderately confident; = Completely confident; And; = Strongly disagree; = Somewhat disagree; = Neither agree nor disagree; = Somewhat agree; = Strongly agree	Post-vaccination experience survey (at Months 8-12)
Primary	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: = Not at all confident; = Not very confident; = Neither (neutral); = Moderately confident; = Completely confident; And; = Strongly disagree; = Somewhat disagree; = Neither agree nor disagree; = Somewhat agree; = Strongly agree	Post-test implementation survey (at Months 11-12)
Primary	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: = Not at all confident; = Not very confident; = Neither (neutral); = Moderately confident; = Completely confident; And; = Strongly disagree; = Somewhat disagree; = Neither agree nor disagree; = Somewhat agree; = Strongly agree	Pre-test implementation survey (at Months 4-5) and post- test implementation survey (at Months 11-12)
Primary	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: = Not at all confident; = Not very confident; = Neither (neutral); = Moderately confident; = Completely confident; And; = Strongly disagree; = Somewhat disagree; = Neither agree nor disagree; = Somewhat agree; = Strongly agree	Post-vaccination experience survey (at Months 8-12)
Primary	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: = Not at all confident; = Not very confident; = Neither (neutral); = Moderately confident; = Completely confident; And; = Strongly disagree; = Somewhat disagree; = Neither agree nor disagree; = Somewhat agree; = Strongly agree	Post-test implementation survey (at Months 11-12)
Primary	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: = Not at all confident; = Not very confident; = Neither (neutral); = Moderately confident; = Completely confident; And; = Strongly disagree; = Somewhat disagree; = Neither agree nor disagree; = Somewhat agree; = Strongly agree	Pre-test implementation survey (at Months 4-5) and post- test implementation survey (at Months 11-12)
Primary	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: = Not at all confident; = Not very confident; = Neither (neutral); = Moderately confident; = Completely confident; And; = Strongly disagree; = Somewhat disagree; = Neither agree nor disagree; = Somewhat agree; = Strongly agree	Post-vaccination experience survey (at Months 8-12)
Primary	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: = Not at all confident; = Not very confident; = Neither (neutral); = Moderately confident; = Completely confident; And; = Strongly disagree; = Somewhat disagree; = Neither agree nor disagree; = Somewhat agree; = Strongly agree	Post-test implementation survey (at Months 11-12)
Primary	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: = Strongly disagree; = Somewhat disagree; = Neither agree nor disagree; = Somewhat agree; = Strongly agree; And; Completely dissatisfied; Somewhat dissatisfied; Neither satisfied nor dissatisfied; Somewhat satisfied; Completely satisfied	Post-implementation of CDS tools up to 12 months
Primary	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	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