Pulmonary EmbolismNCT05351749
Implementing Prescriber-Pharmacist Collaborative Care for Evidence-based Anticoagulant Use
A study testing New-prescription Alert, New-prescription Alert with referral option and Existing-prescription notification to prescriber in people with Pulmonary Embolism and Venous Thromboembolism, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Embolism, Venous Thromboembolism, Atrial Fibrillation
- What is being tested?
- New-prescription Alert, New-prescription Alert with referral option and Existing-prescription notification to prescriber
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 15 Dec 2024
- Phase
- Interventional
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Michigan Medicine provider with prescribing privileges
- Providers in ambulatory care settings
- Prescribe DOAC to patients 18 years and older
Who cannot join
- Providers in inpatient settings
- Providers who are members of the study team
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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.
- Being tested
- New-prescription Alert, New-prescription Alert with referral option, Existing-prescription notification to prescriber, Existing-prescription notification to pharmacist
- Keywords
- Prescribing alerts, Anticoagulation
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New-prescription AlertBehavioural
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.
New-prescription Alert with referral optionBehavioural
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.
Existing-prescription notification to prescriberBehavioural
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.
Existing-prescription notification to pharmacistBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| New-prescription Alert / Existing-prescription notification to prescriber | Experimental | Not described Receives: Behavioral: New-prescription Alert; Behavioral: Existing-prescription notification to prescriber |
| New-prescription Alert w/ referral option/ Existing-prescription notification to prescriber | Experimental | Not described Receives: Behavioral: New-prescription Alert with referral option; Behavioral: Existing-prescription notification to prescriber |
| New-prescription Alert/ Existing-prescription notification to pharmacist | Experimental | Not described Receives: Behavioral: New-prescription Alert; Behavioral: Existing-prescription notification to pharmacist |
| New-prescription Alert w/ referral option/ Existing-prescription notification to pharmacist | Experimental | Not described Receives: Behavioral: New-prescription Alert with referral option; Behavioral: Existing-prescription notification to pharmacist |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number (Proportion) of Notifications (in the Existing-prescription Notification Conditions) That Are Addressed Within 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
Measured: Up to 7 days
Secondary outcomes (3)
The Number (Proportion) of Alerts (in the Newly Prescribed DOAC Alert Conditions) That Are Addressed Within 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
Measured: Up to 7 days
Change in Effect Size for the Existing-prescription Notification Over Time
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.
Measured: Month 0 to 19 months
Change in Effect Size for the Initial Alert Over Time
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.
Measured: Month 0 to 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Aug 2022
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Geoffrey Barnes, University of Michigan
- Investigators
- Geoffrey Barnes, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351749
- Sponsor's protocol ID
- HUM00207165
- Other IDs
- R18HS028562
- Status last verified
- Feb 2026
- First submitted
- 6 Apr 2022
- Last updated
- 30 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barnes GD, Choi SY, Lanham MS, Dorsch MP, Errickson J, Fabbri M, Saraswat A, Seagull FJ, Smith SN. Implementing prescriber-pharmacist collaboration to improve evidence-based medication prescribing using asynchronous, non-interruptive electronic health record notifications. Implement Sci. 2025 Dec 15;21(1):15. doi: 10.1186/s13012-025-01478-9.
PubMed 41398697Smith SN, Lanham MSM, Seagull FJ, Fabbri M, Dorsch MP, Jennings K, Barnes G. System-Wide, Electronic Health Record-Based Medication Alerts for Appropriate Prescribing of Direct Oral Anticoagulants: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Nov 8;8:e64674. doi: 10.2196/64674.
PubMed 39514247Smith SN, Lanham M, Seagull FJ, Dorsch M, Errickson J, Barnes GD. Implementing pharmacist-prescriber collaboration to improve evidence-based anticoagulant use: a randomized trial. Implement Sci. 2023 May 15;18(1):16. doi: 10.1186/s13012-023-01273-4.
PubMed 37189171