Collaborative Nurse-pharmacist Counseling for Self-administered Biologics

Medication Adherence Clinical Trial

— COLLAB  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05798104
• Other study ID #: 80874
• Status: Withdrawn
• Phase: N/A
• Start date: March 2024
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug-Related Side Effects and Adverse Reactions
• Medication Adherence
• Medication Nonadherence

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Tonia Carr

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient-perceived medication knowledge and confidence.	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.	Immediately before and after counseling session during 1 day study visit
Secondary	Medication adverse events/self-administration errors	A pharmacist will perform a follow-up call at three months post-index. The pharmacist will interview the subject to determine if they experienced any ADEs or had any medication self-administration errors.	90 days following study visit
Secondary	Medication adherence/persistence	Medication dispensing records for up to six months post-index at the study institution will be collected by extraction from pharmacy dispensing software by data manager. Medication adherence and persistence will be calculated in terms of PDC and discontinuation of the medication prior to 180 days.	180 days following study visit