Collaborative Nurse-pharmacist Counseling for Self-administered Biologics (COLLAB)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Medication Adherence; Adverse Drug Event; Medication Nonadherence
• Intervention / Treatment: Behavioral: Collaborative nurse-pharmacist counseling

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Tonia Carr
• Investigators: Principal Investigator: Tonia Carr, BSN, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 80874

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No