Perioperative Medication ErrorsNCT04988737
Usability of a Perioperative Medication-Related Clinical Decision Support Application
A study testing Electronic Clinical Decision Support Application in people with Perioperative Medication Errors and Perioperative Adverse Medication Events, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to compare the usability of a novel, medication-related clinical decision support (CDS) application to the current standard medication administration and documentation workflow. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Medication Errors, Perioperative Adverse Medication Events
- What is being tested?
- Electronic Clinical Decision Support Application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2021to 10 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anesthesia Clinicians including attending anesthesiologists, Certified Registered Nurse Anesthetists (CRNAs), and house staff (residents and fellows)
Who cannot join
- Study Staff
- Medical Students
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Usability of a Perioperative Medication-Related Clinical Decision Support Application: A Randomized Controlled Trial
The goal of this study is to compare the usability of a novel, medication-related clinical decision support (CDS) application to the current standard medication administration and documentation workflow. The study will occur in a simulation setting, using a manikin and test patient data - no actual patients will participate. Forty clinician participants will be randomly assigned to either the CDS group (who will complete simulation tasks using the CDS prototype) or the Control group (who will complete simulation tasks using the standard medication administration workflow).
- Being tested
- Electronic Clinical Decision Support Application
- Keywords
- Usability, Clinical Decision Support, Anesthesiology, Medication Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Clinical Decision Support ApplicationOther
Robust, real-time medication-related clinical decision support application for use in the operating room. The application is fully integrated with existing clinical systems. It provides visual alerts for medication errors and adverse medication events at the point-of-care.
| Study group | Role | What they receive |
|---|---|---|
| CDS Group | Experimental | Clinicians complete tasks using the CDS prototype. Briefly, the clinician scans the barcode on the syringe label immediately prior to medication administration. The scan triggers the CDS to display a dosing window with pertinent patient-specific information and/or alert(s) when necessary to prevent a medication error (ME) prior to the medication being administered. Medication data are then sent from the CDS application to the patient's anesthesia record for automatic documentation in real-time, eliminating the need to manually document the medication in the Anesthesia Information Management System (AIMS). When necessary, the CDS application generates alerts to prevent medication errors. Upon receiving an alert, the anesthesia clinician may accept the alert and revise the action that generated the alert, or override the alert and continue with the planned action. Receives: Other: Electronic Clinical Decision Support Application |
| Control Group | No intervention | Clinicians complete tasks using the conventional medication administration and documentation workflow in anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time to complete 7 simulations tasks.
Total time (in seconds) to complete 7 simulations tasks.
Measured: Measured from task start time to task end time, a cumulative average of 15 minutes
Secondary outcomes (2)
Total number of mouse clicks in 7 simulations tasks.
Total count of mouse clicks during all 7 simulations tasks.
Measured: Measured from task start time to task end time, a cumulative average of 15 minutes
Total distance traveled on the screen in pixels for 7 simulation tasks.
Total distance traveled on the screen in pixels during all 7 simulation tasks.
Measured: Measured from task start time to task end time, a cumulative average of 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start27 Jan 2021
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Medication ErrorsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen C. Nanji,M.D.,M.P.H., Massachusetts General Hospital
- Investigators
- Karen C Nanji, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988737
- Sponsor's protocol ID
- 2020P000210
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of a Perioperative Medication-Related Clinical Decision Support Application: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04988737
- Acronym / sponsor ID
- 2020P000210
- Keywords
- Usability, Clinical Decision Support, Anesthesiology, Medication Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare the usability of a novel, medication-related clinical decision support (CDS) application to the current standard medication administration and documentation workflow. The study will occur in a simulation setting, using a manikin and test patient data - no actual patients will participate. Forty clinician participants will be randomly assigned to either the CDS group (who will complete simulation tasks using the CDS prototype) or the Control group (who will complete simulation tasks using the standard medication administration workflow).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| CDS Group | Experimental | Other: Electronic Clinical Decision Support ApplicationClinicians complete tasks using the CDS prototype. Briefly, the clinician scans the barcode on the syringe label immediately prior to medication administration. The scan triggers the CDS to display a dosing window with pertinent patient-specific information and/or alert(s) when necessary to prevent a medication error (ME) prior to the medication being administered. Medication data are then sent from the CDS application to the patient's anesthesia record for automatic documentation in real-time, eliminating the need to manually document the medication in the Anesthesia Information Management System (AIMS). When necessary, the CDS application generates alerts to prevent medication errors. Upon receiving an alert, the anesthesia clinician may accept the alert and revise the action that generated the alert, or override the alert and continue with the planned action. |
| Control Group | No intervention | –Clinicians complete tasks using the conventional medication administration and documentation workflow in anesthesia. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesia Clinicians including attending anesthesiologists, Certified Registered Nurse Anesthetists (CRNAs), and house staff (residents and fellows)
Key exclusion criteria (2 listed)
- Study Staff
- Medical Students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Clinical Decision Support ApplicationRobust, real-time medication-related clinical decision support application for use in the operating room. The application is fully integrated with existing clinical systems. It provides visual alerts for medication errors and adverse medication events at the point-of-care. | Other | CDS Group |
Primary outcome
Total time to complete 7 simulations tasks.
Time frame: Measured from task start time to task end time, a cumulative average of 15 minutes
Total time (in seconds) to complete 7 simulations tasks.
2 secondary outcomes
Total number of mouse clicks in 7 simulations tasks.
Time frame: Measured from task start time to task end time, a cumulative average of 15 minutes
Total distance traveled on the screen in pixels for 7 simulation tasks.
Time frame: Measured from task start time to task end time, a cumulative average of 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Perioperative Medication Errors
Not yet recruiting
RCT: The Effect of an Electronic Clinical Decision Support Application on Perioperative Medication Errors.
Perioperative Medication Errors, Perioperative Adverse Medication Events
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen C Nanji, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Clinical Decision Support Application in people with Perioperative Medication Errors and Perioperative Adverse Medication Events, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total time to complete 7 simulations tasks. (time frame: Measured from task start time to task end time, a cumulative average of 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.