Trial Summary
What is the purpose of this trial?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
Do I need to stop taking my current medications for this trial?
The trial protocol does not specify whether participants must stop taking their current medications.
What data supports the idea that Pharmacist Alerts for Blood Clot Management is an effective treatment?
The available research shows that the method of using pharmacist alerts for blood clot management was not as effective as having an on-floor observer. In a study, staff pharmacists detected significantly fewer alerting orders for adverse reactions compared to an on-floor observer. This suggests that the alert system might not be as reliable in catching potential issues with blood clot management compared to direct monitoring by a healthcare professional.
12345What safety data exists for Pharmacist Alerts for Blood Clot Management?
The safety data for Pharmacist Alerts for Blood Clot Management, which may involve medications like Eliquis (BMS-562247-01), can be indirectly inferred from studies on anticoagulant therapy. One study evaluated the effectiveness of pharmacists in detecting adverse drug reactions (ADRs) related to anticoagulants like warfarin and heparin. It found that staff pharmacists detected fewer ADRs compared to an on-floor observer, suggesting limitations in current alert systems. Another study highlighted the efficiency of real-time clinical alerts for pharmacists, which could improve ADR detection. However, issues like alert fatigue and the overriding of alerts were noted in other studies, indicating challenges in the current alert systems. Overall, while there are systems in place to notify pharmacists of potential ADRs, their effectiveness and the impact on safety need further evaluation.
13567Eligibility Criteria
This trial is for Michigan Medicine providers with prescribing privileges in ambulatory care settings who prescribe direct oral anticoagulants (DOAC) to patients aged 18 and older. Providers working in inpatient settings or those part of the study team cannot participate.Inclusion Criteria
Michigan Medicine provider with prescribing privileges
I am being treated in a walk-in clinic or doctor's office.
I am 18 or older and have been prescribed a DOAC.
Exclusion Criteria
Providers who are members of the study team
Providers in inpatient settings
Participant Groups
The study tests if alerts about prescriptions sent to pharmacists lead to more prescription changes than alerts sent to prescribers. It also examines if having a pharmacist referral option increases prescription changes when initial-prescribing errors occur.
4Treatment groups
Experimental Treatment
Group I: New-prescription Alert/ Existing-prescription notification to pharmacistExperimental Treatment2 Interventions
Group II: New-prescription Alert w/ referral option/ Existing-prescription notification to prescriberExperimental Treatment2 Interventions
Group III: New-prescription Alert w/ referral option/ Existing-prescription notification to pharmacistExperimental Treatment2 Interventions
Group IV: New-prescription Alert / Existing-prescription notification to prescriberExperimental Treatment2 Interventions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
Agency for Healthcare Research and Quality (AHRQ)Collaborator
References
Evaluation of an indirect method of detecting adverse reactions to anticoagulants. [2004]An indirect system of adverse-drug-reaction (ADR) surveillance was evaluated by determining the number of "alerting orders" for suspected ADRs in patients on anticoagulant therapy that were reported by staff pharmacists compared with those detected by an on-floor pharmacist observer. Physicians' orders for patients receiving warfarin or continuous-infusion heparin therapy were monitored during a five-week period to detect "alerting orders" that appeared to indicate the presence of bleeding or excessive hypoprothrombinemia during warfarin therapy or bleeding or thrombocytopenia during continuous-infusion heparin therapy. Alerting orders were classified as antidote, laboratory-test, and dosage-reduction orders, including "hold warfarin" orders; staff pharmacists were taught to detect these orders through inservice-education programs and the use of a training manual. The on-floor observer detected alerting orders through daily monitoring of all study patients' charts and evaluated suspected ADRs using predefined criteria. A total of 1622 physicians' orders were written for 79 patients. Staff pharmacists detected significantly fewer alerting orders than did the on-floor observer (76 versus 273). Also, staff pharmacists reported as alerting orders 21 physicians' orders that did not meet alerting-order criteria. Staff pharmacists reported at least one alerting order for 52 of the 75 patients who had alerting orders identified by the on-floor observer. The use by staff pharmacists of "alerting orders" was not an effective method of detecting anticoagulant-drug adverse reactions when compared with the performance of an on-floor concurrent monitor.
Indication-based prescribing prevents wrong-patient medication errors in computerized provider order entry (CPOE). [2023]To determine whether indication-based computer order entry alerts intercept wrong-patient medication errors.
Clinically Inconsequential Alerts: The Characteristics of Opioid Drug Alerts and Their Utility in Preventing Adverse Drug Events in the Emergency Department. [2018]We examine the characteristics of clinical decision support alerts triggered when opioids are prescribed, including alert type, override rates, adverse drug events associated with opioids, and preventable adverse drug events.
How pharmacists respond to on-line, real-time DUR alerts. [2019]To quantify the type and frequency of drug utilization review (DUR) alerts sent by one claims processor to pharmacists; identify how pharmacists respond to these on-line, real-time DUR messages; and quantify the interventions taken by these pharmacists as a result of these alerts.
Evaluating patient and physician knowledge of risks and safe use of rivaroxaban: a survey across four countries. [2022]At the request of the European Medicines Agency, a Prescriber Guide and Patient Alert Card were developed to increase awareness and understanding about the initiation of rivaroxaban and potential bleeding risk associated with its use. This study evaluated physician and patient awareness and understanding of key safety messages in these educational materials in three waves.
Notification of real-time clinical alerts generated by pharmacy expert systems. [2018]We developed and implemented a strategy for notifying clinical pharmacists of alerts generated in real-time by two pharmacy expert systems: one for drug dosing and the other for adverse drug event prevention. Display pagers were selected as the preferred notification method and a concise, yet readable, format for displaying alert data was developed. This combination of real-time alert generation and notification via display pagers was shown to be efficient and effective in a 30-day trial.
The Overriding of Computerized Physician Order Entry (CPOE) Drug Safety Alerts Fired by the Clinical Decision Support (CDS) Tool: Evaluation of Appropriate Responses and Alert Fatigue Solutions. [2022]Introduction Most computerized physician order entry (CPOE) software come with clinical decision-support components (CDS) that provide prescribers assistance and notify them about adverse drug reactions. An excessive number of alerts in a repeated and non-relevant manner leads to alert fatigue and enforces physicians and pharmacists to alert overrides. King Abdulaziz Medical City (KAMC) in Jeddah still reports a higher percentage of drug alerts overridden by clinicians and pharmacists. Thus, this study was conducted to evaluate CDS alerts overriding and to determine which alerts are clinically irrelevant and need modifications. Methods The study was carried out in the inpatient setting at KAMC in Jeddah, from September 1, 2020, to December 31, 2020. It was designed as a retrospective chart review study that included all red alerts that required comments and were overridden by a physician and pharmacist. Results Among 11350 red alerts, potential drug-drug interaction (pDDI), dose, and allergy alerts represent 57%, 41%, and 2%, respectively, of the total alerts. The most common drug-drug interactions (DDIs) in category X were proton pump inhibitors and clopidogrel (9.9%). The appropriate response by prescribers and pharmacists toward allergy alerts was associated with the highest odds compared with the other alerts (p
Identification of strategies to reduce computerized alerts in an electronic prescribing system using a Delphi approach. [2013]To reach consensus among prescribers of different specialties and experience on the usefulness of computerised alerts and strategies for reducing low-value alerts within a commercial electronic prescribing system.
Nature and management of duplicate medication alerts. [2015]To investigate the nature of duplicate medication (DM) alerts, their management by community pharmacists, and potential characteristics of DM alerts that lead to interventions by pharmacists.
Utilization of a Pharmacy Clinical Surveillance System for Pharmacist Alerting and Communication at a Tertiary Academic Medical Center. [2018]The objective of this analysis is to describe the utilization metrics of a pharmacy clinical surveillance system (PCSS) at a tertiary, academic medical center.We performed a retrospective database analysis assessing rule-based alerts (RBA), interventions and pharmacist communication notes documented in the PCSS from January 1, 2014 to December 31, 2014. Reports were generated on 92 unique RBAs sent to clinicians for evaluation. Metrics assessed included the number of RBAs that were triggered, clinically evaluated, intervened on by pharmacists, and therapeutic category of interventions. Pharmacy communication notes were also evaluated.A total of 399,979 RBAs were triggered through the PCSS. During that time, pharmacists documented a total of 17,733 interventions. The most common RBAs were related to lab abnormalities (132,487; 33 %) and anticoagulation/antiplatelet therapy (126,425; 32.1 %). Interventions were most frequently related to RBAs regarding anticoagulation/antiplatelet therapy (6412; 36 %) and antimicrobial therapy (3320; 19 %). Pharmacist communication was most commonly related to clarification of medication and lab orders, and therapeutic drug monitoring.Based on utilization metrics presented, the implementation of a PCSS has successfully generated RBAs to aid pharmacists in clinical practice and improved departmental documentation and communication. Further analysis is warranted to assess the impact of the RBAs, interventions, and communication notes on outcomes such as hospital cost and adverse drug events.