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

Study Overview
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Brief Summary
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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
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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)

Official Title
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Clinical Decision Support Tools to Increase HPV Vaccination in Pharmacies

Conditions
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Human Papillomavirus-Related Carcinoma

Intervention / Treatment
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* Other: Discussion
* Other: Educational Activity
* Behavioral: Healthcare Activity
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (staff focus group)<br>Staff participate in facilitated planning discussions to develop CDS tools on study. | Other: Discussion<br>* Participate in focus group<br>* Other names: Discuss;Other: Survey Administration<br>* Complete survey<br>|
| Experimental: Group II (staff CDS tool utilization)<br>Staff receives CDS tools training and implements CDS tools to facilitate HPV vaccination on study. | Other: Educational Activity<br>* Undergo training to use CDS tool<br>Behavioral: Healthcare Activity<br>* Utilize CDS tool<br>* Other names: Healthcare;Other: Survey Administration<br>* Complete survey<br>|
| Experimental: Group III (parent survey)<br>Parents complete survey post-intervention on study. | Other: Survey Administration<br>* Complete survey<br>|

What is the study measuring?
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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) | 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: = 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |