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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether alerts sent to pharmacists result in more changes in blood clot medication prescriptions than those sent to doctors. It also examines if including a pharmacist referral option with new prescription alerts increases prescription changes when errors occur. The goal is to enhance teamwork between doctors and pharmacists in managing high-risk medications like blood thinners, such as Eliquis. Healthcare providers in Michigan who prescribe blood thinners and work in outpatient settings are well-suited for this study. As an unphased trial, this study provides a unique opportunity to contribute to improving healthcare collaboration and patient safety.

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 prior data suggests that this protocol is safe for blood clot management?

Research has shown that alerts about blood thinner medications are generally safe and improve care. These alerts help doctors and pharmacists collaborate more effectively, ensuring correct medication use. For instance, alerts can notify them if a drug might be unsuitable due to changes in kidney function or other factors, allowing safe prescription adjustments.

In one study, pharmacists checked prescriptions and resolved issues, effectively managing blood thinner use. Another study found that when pharmacists participated, they often intervened to enhance patient care, issuing alert cards or contacting doctors to adjust prescriptions if necessary.

These alerts do not introduce new medications or treatments but aim to enhance existing systems, presenting no new safety concerns. Instead, they help prevent mistakes and make blood thinner use safer. Overall, the focus remains on better communication and safer medication use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these trials because they aim to enhance blood clot management by improving communication between healthcare providers. Unlike traditional methods that rely solely on prescribers or pharmacists to catch potential issues, these trials test a system of alerts and notifications that actively involve both parties. This approach could lead to quicker interventions and better outcomes by ensuring that both pharmacists and prescribers are promptly informed about existing and new prescriptions. The addition of a referral option in some alerts could further streamline patient care by making it easier to connect patients with specialist services when necessary. By focusing on improving the flow of information, these trials could revolutionize how blood clot treatments are managed, potentially reducing complications and improving patient safety.

What evidence suggests that this trial's treatments could be effective for blood clot management?

Research has shown that involving pharmacists in medication alerts improves prescription accuracy, particularly for blood thinners. In this trial, one arm will notify pharmacists about current prescriptions, enabling them to identify and correct errors related to drug interactions or incorrect doses. Another arm will offer a referral option to a blood thinner clinic with alerts, which studies suggest can further enhance prescription changes, leading to better patient outcomes. Evidence indicates that pharmacist involvement in alerts results in better medication management than alerts sent only to doctors. This team approach is recommended to enhance the safety of blood thinner use. ^{1 2 3 4 5}

Who Is on the Research Team?

Geoffrey Barnes, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10184412/

Implementing pharmacist-prescriber collaboration to improve ... This study will improve upon existing alert systems by testing novel medication alerts that encourage collaboration between prescribers.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05351749

Implementing Prescriber-Pharmacist Collaborative Care for ... 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 ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.035859

Pharmacist Use of a Population Management Dashboard ... We evaluated a nationwide DOAC population management dashboard rollout whose purpose includes pharmacist review and correction of off‐label dosing ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2475037922023627

Implementing evidence‐based anticoagulant prescribing Through a robust UCD process, we have identified key recommendations for implementing medication alerts aimed at improving evidence‐based DOAC prescribing.

5. researchgate.net researchgate.net/publication/370775048_Implementing_pharmacist-prescriber_collaboration_to_improve_evidence-based_anticoagulant_use_a_randomized_trial

(PDF) Implementing pharmacist-prescriber collaboration to ... The aims of the project are to (1) determine the effect of notifications targeting existing inappropriate DOAC prescriptions; (2) examine the effect of alerts ...