Human Papillomavirus-Related CarcinomaNCT05831540
Clinical Decision Support Tools to Increase Human Papillomavirus (HPV) Vaccination in Adolescents in Pharmacies
A study testing Discussion, Educational Activity and Healthcare Activity in people with Human Papillomavirus-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus-Related Carcinoma
- What is being tested?
- Discussion, Educational Activity and Healthcare Activity
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2024to 22 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Clinical Decision Support Tools to Increase HPV Vaccination in Pharmacies
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.
Read the 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)
- Conditions
- Human Papillomavirus-Related Carcinoma
- Being tested
- Discussion, Educational Activity, Healthcare Activity, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscussionOther
Also called Discuss
Participate in focus group
Educational ActivityOther
Undergo training to use CDS tool
Healthcare ActivityBehavioural
Also called Health Care Activity, Healthcare
Utilize CDS tool
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Group I (staff focus group) | Experimental | Staff participate in facilitated planning discussions to develop CDS tools on study. Receives: Other: Discussion; Other: Survey Administration |
| Group II (staff CDS tool utilization) | Experimental | Staff receives CDS tools training and implements CDS tools to facilitate HPV vaccination on study. Receives: Other: Educational Activity; Behavioral: Healthcare Activity; Other: Survey Administration |
| Group III (parent survey) | Experimental | Parents complete survey post-intervention on study. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Outcomes of implementation analyzed using nonparametric tests appropriate for small sample statistics, like Wilcoxon sign-rank test.
Measured: 12 months prior to CDS tool implementation (baseline) up to 5 months post-implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start28 Feb 2024
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parth Shah, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831540
- Sponsor's protocol ID
- RG1122655
- Other IDs
- NCI-2023-01989, 11086
- Status last verified
- Dec 2024
- First submitted
- 20 Mar 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support Tools to Increase HPV Vaccination in Pharmacies
- ClinicalTrials.gov ID
- NCT05831540
- Acronym / sponsor ID
- RG1122655
- Conditions
- Human Papillomavirus-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (staff focus group) | Experimental | Other: Discussion, Other: Survey AdministrationStaff participate in facilitated planning discussions to develop CDS tools on study. |
| Group II (staff CDS tool utilization) | Experimental | Other: Educational Activity, Behavioral: Healthcare Activity, Other: Survey AdministrationStaff receives CDS tools training and implements CDS tools to facilitate HPV vaccination on study. |
| Group III (parent survey) | Experimental | Other: Survey AdministrationParents complete survey post-intervention on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiscussionAlso: DiscussParticipate in focus group | Other | Group I (staff focus group) |
| Educational ActivityUndergo training to use CDS tool | Other | Group II (staff CDS tool utilization) |
| Healthcare ActivityAlso: Health Care Activity, HealthcareUtilize CDS tool | Behavioural | Group II (staff CDS tool utilization) |
| Survey AdministrationComplete survey | Other | Group I (staff focus group), Group II (staff CDS tool utilization), Group III (parent survey) |
Primary outcome
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)
Time frame: 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.
Acceptability of CDS tools: Pharmacy staff (Aim II)
Time frame: 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
Change in Acceptability of pharmacy-based HPV vaccination: Pharmacy staff (Aim II)
Time frame: 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
Acceptability of pharmacy-based HPV vaccination: Parents (Aim II)
Time frame: 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 CDS tools: Pharmacy staff (Aim II)
Time frame: 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
Appropriateness of pharmacy-based HPV vaccination: Pharmacy staff (Aim II)
Time frame: 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
Appropriateness of pharmacy-based HPV vaccination: Parents (Aim II)
Time frame: 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
Feasibility of CDS tools: Pharmacy staff (Aim II)
Time frame: 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
Feasibility of pharmacy-based HPV vaccination: Pharmacy staff (Aim II)
Time frame: 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)
Time frame: 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
Usability of CDS tools: Pharmacy staff (Aim II)
Time frame: 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
Parents' experience Survey (Aim II)
Time frame: 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
HPV vaccination rate per pharmacist at each pharmacy (Aim II)
Time frame: 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.
1 secondary outcome
Rate of other adolescent vaccinations per pharmacist at each pharmacy (Aim II)
Time frame: 12 months prior to CDS tool implementation (baseline) up to 5 months post-implementation
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parth Shah principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussion, Educational Activity and Healthcare Activity in people with Human Papillomavirus-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Up to 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.