Medication AdherenceCOLLABNCT05798104
Collaborative Nurse-pharmacist Counseling for Self-administered Biologics
A study testing Collaborative nurse-pharmacist counseling in people with Medication Adherence and Medication Nonadherence, run by Tonia Carr at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Medication Nonadherence, Adverse Drug Event
- What is being tested?
- Collaborative nurse-pharmacist counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2024to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Collaborative nurse-pharmacist counseling
- Medical subject headings
- Medication Adherence, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative nurse-pharmacist counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Collaborative nurse-pharmacist counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before and after counseling session during 1 day study visit
Secondary outcomes (2)
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.
Measured: 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.
Measured: 180 days following study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study startMar 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: research is not clinically appropriate at this time due to competing demands and patient care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonia Carr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tonia Carr, University of Kentucky
- Investigators
- Tonia Carr, BSN, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798104
- Sponsor's protocol ID
- 80874
- Acronym
- COLLAB
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Knowledge and Confidence in Specialty Biologic Self-administration Through Collaborative Nurse-pharmacist Counseling
- ClinicalTrials.gov ID
- NCT05798104
- Acronym / sponsor ID
- COLLAB / 80874
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: research is not clinically appropriate at this time due to competing demands and patient care
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tonia CarrUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collaborative nurse-pharmacist counseling | Experimental | Behavioral: Collaborative nurse-pharmacist counselingCollaborative 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative nurse-pharmacist counselingAt 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. | Behavioural | Collaborative nurse-pharmacist counseling |
Primary outcome
Change in patient-perceived medication knowledge and confidence.
Time frame: Immediately before and after counseling session during 1 day study visit
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.
2 secondary outcomes
Medication adverse events/self-administration errors
Time frame: 90 days following study visit
Medication adherence/persistence
Time frame: 180 days following study visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonia Carr, BSN principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative nurse-pharmacist counseling in people with Medication Adherence and Medication Nonadherence, run by Tonia Carr at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-perceived medication knowledge and confidence. (time frame: Immediately before and after counseling session during 1 day study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.