Collaborative Nurse-pharmacist Counseling for Self-administered Biologics

NCT ID: NCT05798104

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-11-30

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.

Conditions

Medication Adherence; Medication Nonadherence; Adverse Drug Event

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Collaborative nurse-pharmacist counseling

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.

Group Type: EXPERIMENTAL

Collaborative nurse-pharmacist counseling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tonia Carr

OTHER

Sponsor Role: lead

Responsible Party

Tonia Carr

Nurse Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tonia Carr, BSN

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

80874

Identifier Type: -

Identifier Source: org_study_id