Pharmacist Alerts for Blood Clot Management

Overseen By Jake Seagull, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: DOAC

Disqualifiers: Inpatient providers, Study team members

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

306 Participants Needed

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on how pharmacists and prescribers manage prescriptions, particularly for blood thinners.

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. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for blood clot management?

The research does not provide direct evidence of the effectiveness of pharmacist alerts for blood clot management, but it highlights the challenges pharmacists face in detecting adverse reactions to anticoagulants, suggesting that improved alert systems could potentially enhance patient safety. ^{1 2 3 4 5}

What 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. ^{1 3 5 6 7}

Is the Pharmacist Alerts for Blood Clot Management treatment generally safe for humans?

The research does not provide specific safety data for the Pharmacist Alerts for Blood Clot Management treatment, but it does highlight challenges in detecting adverse drug reactions (side effects) with anticoagulants (blood thinners) like warfarin and heparin, which are related to blood clot management. ^{1 3 5 6 7}

Is the treatment in the trial 'Pharmacist Alerts for Blood Clot Management' a promising treatment?

Yes, the treatment is promising because it uses real-time alerts to help pharmacists manage blood clot medications more effectively, improving patient safety and communication. ^{1 6 8 9 10}

How does the pharmacist alert system for blood clot management differ from other treatments?

The pharmacist alert system for blood clot management is unique because it uses real-time alerts to notify pharmacists of potential issues with anticoagulant therapy, such as bleeding risks, allowing for timely interventions. This system enhances the traditional monitoring of blood clot treatments by providing immediate feedback and improving communication between pharmacists and healthcare providers. ^{1 6 8 9 10}

Research Team

Geoffrey Barnes, MD

Principal Investigator

University of Michigan

Eligibility 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of prescriber-pharmacist collaborative care for anticoagulant use

18 months

Follow-up

Participants are monitored for changes in prescription practices and outcomes

4 weeks

Treatment Details

Interventions

• Existing-prescription notification to pharmacist
• Existing-prescription notification to prescriber
• New-prescription Alert
• New-prescription Alert with referral option

Trial Overview 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.

Participant Groups

Group I: New-prescription Alert/ Existing-prescription notification to pharmacist Experimental Treatment 2 Interventions

Group II: New-prescription Alert w/ referral option/ Existing-prescription notification to prescriber Experimental Treatment 2 Interventions

Group III: New-prescription Alert w/ referral option/ Existing-prescription notification to pharmacist Experimental Treatment 2 Interventions

Group IV: New-prescription Alert / Existing-prescription notification to prescriber Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Findings from Research

In a study monitoring anticoagulant therapy over five weeks, on-floor pharmacists detected significantly more adverse drug reaction (ADR) alerting orders (273) compared to staff pharmacists (76), highlighting the importance of direct observation in identifying potential drug-related issues.

Staff pharmacists misidentified some physician orders as alerting orders, indicating that relying solely on indirect surveillance methods may not be effective for detecting ADRs in patients on anticoagulants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an indirect method of detecting adverse reactions to anticoagulants. Swanson, CN., Keys, PW.[2004]

The implementation of indication-based computer order entry alerts at an academic medical center intercepted 32 wrong-patient medication errors over 6 years, resulting in an interception rate of 0.25 errors per 1000 alerts.

The alerts were effective regardless of the prescriber's location or type, and notably, 59% of intercepted errors occurred when the prescriber had both patients' charts open, highlighting the importance of these alerts in preventing medication errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indication-based prescribing prevents wrong-patient medication errors in computerized provider order entry (CPOE). Galanter, W., Falck, S., Burns, M., et al.[2023]

Opioid alerts in clinical decision support systems were overridden 96.3% of the time, indicating a high override rate compared to non-opioid alerts, which raises concerns about alert fatigue among healthcare providers.

Despite the high override rates, only 0.31% of patients experienced adverse drug events related to opioids, and none of these events were preventable by the alerts, suggesting that while alerts can avert some adverse events, the system generates many unnecessary alerts that could hinder patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Inconsequential Alerts: The Characteristics of Opioid Drug Alerts and Their Utility in Preventing Adverse Drug Events in the Emergency Department. Genco, EK., Forster, JE., Flaten, H., et al.[2018]

During a one-year study involving 55,000 Medicaid recipients in Delaware, pharmacists received over 83,000 drug utilization review (DUR) alerts, leading to a significant 20.9% of prescriptions not being dispensed due to these alerts.

Pharmacists' responses to DUR alerts varied widely, with different actions taken based on the type of alert and drug class, indicating the importance of tailored communication in improving medication safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How pharmacists respond to on-line, real-time DUR alerts. Armstrong, EP., Denemark, CR.[2019]

A study involving surveys of physicians and patients in France, Germany, Spain, and the UK showed that both groups had high awareness of the bleeding risks associated with rivaroxaban, with 80% of patients and 92-94% of physicians answering correctly about this risk.

The educational materials, including the Prescriber Guide and Patient Alert Card, effectively communicated key safety information, as evidenced by high knowledge levels regarding indications and necessary precautions among both patients and physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating patient and physician knowledge of risks and safe use of rivaroxaban: a survey across four countries. Zografos, L., Wolin, D., Andrews, E., et al.[2022]

A new strategy was created to notify clinical pharmacists about real-time alerts for drug dosing and adverse drug events, using display pagers as the notification method.

In a 30-day trial, this system proved to be both efficient and effective, enhancing the pharmacists' ability to respond to critical medication alerts promptly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notification of real-time clinical alerts generated by pharmacy expert systems. Miller, JE., Reichley, RM., McNamee, LA., et al.[2018]

In a study of 11,350 overridden alerts at King Abdulaziz Medical City, 57% were related to potential drug-drug interactions, indicating a high prevalence of alerts that may contribute to alert fatigue among clinicians.

The study identified 14 strategies to refine alerts, which could reduce irrelevant notifications by 32%, potentially improving the effectiveness of clinical decision support systems and reducing alert fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Naeem, A., Alwadie, AF., Alshehri, AM., et al.[2022]

A consensus was reached among prescribers on the importance of retaining allergy and intolerance alerts in electronic prescribing systems, while opinions varied on the value of other alerts.

Most prescribers felt that adjusting therapeutic duplication alerts and changing local messages to hyperlinks would not compromise patient safety, highlighting the effectiveness of involving users in customizing alert systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of strategies to reduce computerized alerts in an electronic prescribing system using a Delphi approach. Baysari, MT., Westbrook, JI., Egan, B., et al.[2013]

Community pharmacists encounter an average of 20.4 duplicate medication (DM) alerts for every 100 dispensed drugs, but in half of these cases, they determine there is no risk in using both medications concurrently.

While prescription modifications based on DM alerts are infrequent, pharmacists often take other actions, such as updating patient records or informing patients, especially for first-time prescriptions, which prompts action in 40% of cases compared to only 14% for refills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nature and management of duplicate medication alerts. Heringa, M., Floor, A., Meijer, WM., et al.[2015]

In 2014, a pharmacy clinical surveillance system (PCSS) triggered 399,979 rule-based alerts (RBAs), leading to 17,733 documented pharmacist interventions, highlighting its effectiveness in identifying potential medication issues.

The most common alerts were related to lab abnormalities and anticoagulation therapy, with pharmacists primarily intervening in these areas, suggesting that the PCSS significantly enhances medication safety and communication in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of a Pharmacy Clinical Surveillance System for Pharmacist Alerting and Communication at a Tertiary Academic Medical Center. Hohlfelder, B., Stashek, C., Anger, KE., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an indirect method of detecting adverse reactions to anticoagulants. [2004]

2. England pubmed.ncbi.nlm.nih.gov

Indication-based prescribing prevents wrong-patient medication errors in computerized provider order entry (CPOE). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Clinically Inconsequential Alerts: The Characteristics of Opioid Drug Alerts and Their Utility in Preventing Adverse Drug Events in the Emergency Department. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

How pharmacists respond to on-line, real-time DUR alerts. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating patient and physician knowledge of risks and safe use of rivaroxaban: a survey across four countries. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Notification of real-time clinical alerts generated by pharmacy expert systems. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

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]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Identification of strategies to reduce computerized alerts in an electronic prescribing system using a Delphi approach. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Nature and management of duplicate medication alerts. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Utilization of a Pharmacy Clinical Surveillance System for Pharmacist Alerting and Communication at a Tertiary Academic Medical Center. [2018]