University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT05351749
The researchers hypothesize that existing-prescription notifications directed to pharmacists are more likely to lead to a prescription change than existing-prescription notifications directed to prescribers. Furthermore, the researchers hypothesize that the availability of a pharmacist referral option is associated with a higher rate of prescription changes for initial-prescription alerts that are directed to the prescriber at the time of initial-prescribing errors.
Findings from this project will establish a framework for implementing prescriber-pharmacist collaboration for high risk medications, including anticoagulants
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Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Please note that the 3rd and 4th outcome measures are conditional on the outcomes of the 1st and 2nd outcome measures respectively.
Please note that enrollment of 300 will provide sufficient power to study.
Study data was obtained through data downloads and not from individual participant interactions. Final data collection for all outcomes took place on Dec 15, 2024.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Prescribers:
Inclusion criteria
Exclusion criteria
An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription.
An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance.
Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Time frame: Up to 7 days
Existing-prescription notification conditions = Prescriber notification & Pharmacist notification
The number of notifications (in the existing-prescription notification conditions) that are addressed within 7 days/ total number of notifications
Time frame: Up to 7 days
Newly prescribed DOAC alert conditions= Medication alert & Medication alert + referral
Data reported represents the number of alerts (in the newly prescribed DOAC alert conditions) that are addressed within 7 days/ total number of alerts
Time frame: Month 0 to 19 months
Reported on at the institution level (not individual level). Existing-prescription notification conditions = Prescriber notification & Pharmacist notification
The number of notifications (in the existing-prescription notification conditions) that are addressed within 7 days/ total number of notifications, shown over multiple time periods.
This outcome measure analysis is based on the results of outcome #1.
Time frame: Month 0 to 19 months
Reported on at the institution level (not individual level). Newly prescribed DOAC alert condition= Medication alert & Medication alert + referral
The number of new prescription alerts that are addressed within 7 days/ total number of alerts, shown over multiple time periods.
This outcome measure analysis is based on the results of outcome #2.
Time frame: 30 days from alert or notification
Data was gathered from the patients of participants within 30 days of a notification being sent via post-hoc examination of electronic medical record data
Clinical adverse events assessed will include major 21 and clinically-relevant non-major bleeding (CRNMB)22 events, as defined by the International Society on Thrombosis and Haemostasis (ISTH), new or recurrent VTE events, and stroke or systemic arterial embolic events. Each of these events will be captured using health informatics tools (described below) and independently adjudicated by two expert clinicians (one pharmacist, one prescriber) who meet once in Y1 and twice in Y2 to adjudicate any potential adverse events. We will use two Michigan Medicine-developed health informatics tools, DataDirect and EMERSE,23 to identify adverse events and capture clinical data (e.g., notes, labs, imaging, procedure reports) for adjudication.
University of Michigan
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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