Back to resultsCollaborative Nurse-pharmacist Counseling for Self-administered Biologics (COLLAB)
Primary Purpose
Medication Adherence, Medication Nonadherence, Adverse Drug Event
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative nurse-pharmacist counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Medication Adherence
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
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Collaborative nurse-pharmacist counseling
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05798104
Brief Title
Collaborative Nurse-pharmacist Counseling for Self-administered Biologics
Acronym
COLLAB
Official Title
Improving Patient Knowledge and Confidence in Specialty Biologic Self-administration Through Collaborative Nurse-pharmacist Counseling
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tonia Carr
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Medication Nonadherence, Adverse Drug Event
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collaborative nurse-pharmacist counseling
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Collaborative nurse-pharmacist counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in patient-perceived medication knowledge and confidence.
Description
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.
Time Frame
Immediately before and after counseling session during 1 day study visit
Secondary Outcome Measure Information:
Title
Medication adverse events/self-administration errors
Description
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.
Time Frame
90 days following study visit
Title
Medication adherence/persistence
Description
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.
Time Frame
180 days following study visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian N Rhudy, PharmD
Phone
859-2180727
Email
christian.rhudy@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tonia Carr, BSN
Phone
859-562-1737
Email
Tonia.carr@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tonia Carr, BSN
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian N Rhudy, PharmD
Phone
859-218-0727
Email
christian.rhudy@uky.edu
First Name & Middle Initial & Last Name & Degree
Tonia Carr, BSN
Phone
859-562-1737
Email
Tonia.carr@uky.edu
First Name & Middle Initial & Last Name & Degree
Tonia Carr, BSN
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Collaborative Nurse-pharmacist Counseling for Self-administered Biologics
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