Perioperative Medication ErrorsNCT04342013
RCT: The Effect of an Electronic Clinical Decision Support Application on Perioperative Medication Errors.
A study testing Electronic Clinical Decision Support Application in people with Perioperative Medication Errors and Perioperative Adverse Medication Events, run by Karen C. Nanji,M.D.,M.P.H..
Trial summary
The purpose of this study is to assess the effect of a novel clinical decision support application on the rate of perioperative medication errors and preventable adverse medication events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Medication Errors, Perioperative Adverse Medication Events
- What is being tested?
- Electronic Clinical Decision Support Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anesthesia clinician (anesthesiologists, certified registered nurse anesthetists (CRNAs), student nurse anesthetists, fellows and residents) at Massachusetts General Hospital.
Who cannot join
- Study staff
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of a Novel Electronic Clinical Decision Support Application on Perioperative Medication Errors and Adverse Medication Events: a Randomized Controlled Trial
The purpose of this study is to assess the effect of a novel clinical decision support application on the rate of perioperative medication errors and preventable adverse medication events. The investigators hypothesize that the perioperative clinical decision support application will reduce the incidence of perioperative medication errors and adverse medication events compared to the standard of care.
- Being tested
- Electronic Clinical Decision Support Application
- Keywords
- medication safety, perioperative, anesthesiology, clinical decision support
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 |
|---|---|---|
| Perioperative Clinical Decision Support Application | Experimental | Participants will be observed performing clinical tasks and documenting medication administrations with use of the clinical decision support application in the perioperative setting. Receives: Other: Electronic Clinical Decision Support Application |
| No Perioperative Clinical Decision Support Application | No intervention | Participants will be observed performing clinical tasks and documenting medication administrations without use of the clinical decision support application in the perioperative setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined incidence of medication errors and adverse medication events in the perioperative setting
Number of medication errors and adverse medication events / number of medications administered
Measured: 6 months
Secondary outcomes (4)
Incidence of medication errors the perioperative setting
Number of errors / number of medications administered
Measured: 6 months
Incidence of adverse medication events in the perioperative setting
Number of adverse medication events / number of medications administered
Measured: 6 months
Preventability of medication errors and adverse medication events
Four-point Likert scale for preventability: definitely preventable, probably preventable, probably not preventable, and definitely not preventability
Measured: 6 months
Severity of harm (or potential harm) associated with both medication errors and adverse medication events in the perioperative setting
Four-point Likert scale for severity:
Fatal
Life-threatening: The event has the potential to cause symptoms that if not treated would put the patient at risk of death.
Serious: The event has the potential to cause symptoms that are associated with a serious level of harm that is not high enough to be life-threatening.
Significant: The event has the potential to cause symptoms that while harmful to the patient pose little or no threat to the patient's function.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative Medication ErrorsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, non-blinded, parallel-arm clinical trial to assess the incidence of medication errors and adverse medication events with and without the use of an electronic clinical decision support application.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karen C. Nanji,M.D.,M.P.H.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karen C. Nanji,M.D.,M.P.H., Massachusetts General Hospital
- Investigators
- Karen C Nanji, M.D., M.P.H., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342013
- Sponsor's protocol ID
- K08HS024764
- Status last verified
- Nov 2025
- First submitted
- 1 Apr 2020
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nanji KC, Patel A, Shaikh S, Seger DL, Bates DW. Evaluation of Perioperative Medication Errors and Adverse Drug Events. Anesthesiology. 2016 Jan;124(1):25-34. doi: 10.1097/ALN.0000000000000904.
PubMed 26501385