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临床试验/NCT05798104
NCT05798104撤回不适用

Improving Patient Knowledge and Confidence in Specialty Biologic Self-administration Through Collaborative Nurse-pharmacist Counseling

Tonia Carr1 个研究点 分布在 1 个国家开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
Tonia Carr
试验地点
1
主要终点
Change in patient-perceived medication knowledge and confidence.

研究概览

简要总结

The goal of this clinical trial is to learn if nurse-pharmacist counseling can improve patient knowledge and confidence and prevent side effects in patients who start a biologic medication in-office and later continue the medication at home. The main question it aims to answer are:

• Does nurse-pharmacist counseling improve patient-reported knowledge and confidence in biologic self-treatment when moving from in-office to at-home administration?

Participants will attend a brief counseling session in office and respond to a pre-counseling and post-counseling survey to look at medication knowledge and confidence. Participants will be contacted at three months after the survey to ask if they had any side effects related to their biologic medicine. Data will be collected from the participant's medical record at the study institution for up to six months after the study counseling session.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • Referred to University of Kentucky Specialty and Infusion Services for clinic-administration of a biologic medication
  • Biologic medication is omalizumab, risankizumab-rzaa or ustekinumab
  • Medication administration will be transitioned to self-administration

排除标准

  • Less than 18 years of age
  • have previously received the qualifying biologic at another institution
  • non-English speaking subjects
  • Subject will not be performing self-administration at home
  • Does not transition to medication self-administration

研究组 & 干预措施

Collaborative nurse-pharmacist counseling

Experimental

Collaborative nurse-pharmacist counseling - At the interventional appointment, study participants will first complete a modified Okere-Reiner pre-survey assessing patient perceptions of confidence and knowledge in their biologic therapy. Subsequently, a pharmacist will perform a refresher medication counseling, detailing indication, dosing, storage, and side effects. Upon completion of this counseling, an infusion nurse will then provide education demonstrating proper self-administration to the patient. The patient will then self-administer the medication with coaching and direct observation from the nurse. Afterwards, the patient will complete the Okere-Reiner post-survey to determine the effectiveness of the counseling session at improving perceived confidence and knowledge. Patients will complete both the pre-and post-surveys with direct entry to REDCap on an institution iPad during the study intervention visit.

干预措施: Collaborative nurse-pharmacist counseling (Behavioral)

结局指标

主要结局

Change in patient-perceived medication knowledge and confidence.

时间窗: Immediately before and after counseling session during 1 day study visit

Patient knowledge and confidence will be assessed pre- and post-survey during the study counseling visit utilizing a modified Okere-Renier survey. Investigators hypothesize that patient knowledge and confidence in self-administering their biologic will increase after receipt of the combined nurse-pharmacist counseling intervention.

次要结局

  • Medication adverse events/self-administration errors(90 days following study visit)
  • Medication adherence/persistence(180 days following study visit)

研究者

发起方
Tonia Carr
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tonia Carr

Nurse Manager

University of Kentucky

研究点 (1)

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