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Clinical Trials/NCT05798104
NCT05798104
Withdrawn
N/A

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

Tonia Carr1 site in 1 countryMarch 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Medication Adherence
Sponsor
Tonia Carr
Locations
1
Primary Endpoint
Change in patient-perceived medication knowledge and confidence.
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2024
End Date
November 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Tonia Carr
Responsible Party
Sponsor Investigator
Principal Investigator

Tonia Carr

Nurse Manager

University of Kentucky

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in patient-perceived medication knowledge and confidence.

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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