Clinical trial NCT05831540: Clinical Decision Support Tools to Increase Human Papillomavirus (HPV) Vaccination in Adolescents in Pharmacies
Official title: Clinical Decision Support Tools to Increase HPV Vaccination in Pharmacies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Human Papillomavirus-Related Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Up to 6 months
measure: Acceptability of CDS tools: Pharmacy staff (Aim II)
timeFrame: Post-implementation of CDS tools survey (at Months 11-12)
measure: Change in Acceptability of pharmacy-based HPV vaccination: Pharmacy staff (Aim II)
timeFrame: Pre-implementation of CDS Tools survey (at Months 4-5) and post- test implementation survey (at Months 11-12)
measure: Acceptability of pharmacy-based HPV vaccination: Parents (Aim II)
timeFrame: Post-vaccination experience survey (at Months 8-12)
measure: Appropriateness of CDS tools: Pharmacy staff (Aim II)
timeFrame: Post-test implementation survey (at Months 11-12)
measure: Appropriateness of pharmacy-based HPV vaccination: Pharmacy staff (Aim II)
timeFrame: Pre-test implementation survey (at Months 4-5) and post- test implementation survey (at Months 11-12)
measure: Appropriateness of pharmacy-based HPV vaccination: Parents (Aim II)
timeFrame: Post-vaccination experience survey (at Months 8-12)
measure: Feasibility of CDS tools: Pharmacy staff (Aim II)
timeFrame: Post-test implementation survey (at Months 11-12)
measure: Feasibility of pharmacy-based HPV vaccination: Pharmacy staff (Aim II)
timeFrame: Pre-test implementation survey (at Months 4-5) and post- test implementation survey (at Months 11-12)
measure: Feasibility of pharmacy-based HPV vaccination: Parents (Aim II)
timeFrame: Post-vaccination experience survey (at Months 8-12)
measure: Usability of CDS tools: Pharmacy staff (Aim II)
timeFrame: Post-test implementation survey (at Months 11-12)
measure: Parents' experience Survey (Aim II)
timeFrame: Post-implementation of CDS tools up to 12 months
measure: HPV vaccination rate per pharmacist at each pharmacy (Aim II)
timeFrame: 12 months prior to CDS tool implementation (baseline) up to 5 months post-implementation
Secondary outcomes:
measure: Rate of other adolescent vaccinations per pharmacist at each pharmacy (Aim II)
timeFrame: 12 months prior to CDS tool implementation (baseline) up to 5 months post-implementation
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Parth Shah
role: PRINCIPAL_INVESTIGATOR
References: