Collaborative Nurse-pharmacist Counseling for Self-administered Biologics

NCT05798104 | Withdrawn

• 1 other identifier: 80874
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Medication adverse events/self-administration errors

  90 days following study visit

• Medication adherence/persistence

  180 days following study visit

Study Arms (1)

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.

Behavioral: Collaborative nurse-pharmacist counseling

Interventions

Collaborative nurse-pharmacist counseling 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.

Collaborative nurse-pharmacist counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tonia Carr: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40503, United States

Location

MeSH Terms

Conditions

Medication Adherence; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Chemically-Induced Disorders

Study Officials

• Tonia Carr, BSN

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse Manager

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 4, 2023
• Study Start: March 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)