Atrial Fibrillation, Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
Prescribing alerts, Anticoagulation
Brief 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. 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
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.
Interventions
BEHAVIORALNew-prescription Alert
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.
BEHAVIORALNew-prescription Alert with referral option
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.
BEHAVIORALExisting-prescription notification to prescriber
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.
BEHAVIORALExisting-prescription notification to pharmacist
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.
Sponsors
University of Michigan
Agency for Healthcare Research and Quality (AHRQ)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Prescribers: Inclusion Criteria: * Michigan Medicine provider with prescribing privileges * Providers in ambulatory care settings * Prescribe DOAC to patients 18 years and older
Exclusion criteria
* Providers in inpatient settings * Providers who are members of the study team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number (Proportion) of Notifications (in the Existing-prescription Notification Conditions) That Are Addressed Within 7 Days. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number (Proportion) of Alerts (in the Newly Prescribed DOAC Alert Conditions) That Are Addressed Within 7 Days. | 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 |
| Change in Effect Size for the Existing-prescription Notification Over Time | 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. |
| Change in Effect Size for the Initial Alert Over Time | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGeoffrey Barnes, MD
University of Michigan
Participant flow
Pre-assignment details
Assignment to conditions for alerts and notifications made upon first receiving either alert or notification. Receiving only alerts or only notifications de facto 'moves' participant to a new condition for only receiving alerts/only notifications. Similarly, if an alert/notification is deemed to not fit study criteria (e.g. if a patient hospitalized for any reason within 7 days of the alert), this may shift the participant's assignment as they no longer have both an alert and a notification.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age >= 18 years | 306 Participants |
| Clinical Role House Officer | 1 Participants |
| Clinical Role Primary Care Clinician | 18 Participants |
| Clinical Role Specialty Care Clinician | 9 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
None listed