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临床试验/NCT05831540
NCT05831540终止不适用

Clinical Decision Support Tools to Increase HPV Vaccination in Pharmacies

Fred Hutchinson Cancer Center2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
31
试验地点
2
主要终点
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)

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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