An interventional study of Unrestricted and Restricted in Medical Errors and Medical Order Entry Systems, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Columbia University · Not applicable, Interventional, and Other
This study is designed to achieve the following aims:
Currently, at least 70,000 U.S. physicians use computerized provider order entry (CPOE) to place orders. This number is expected to rise sharply as hospitals continue to take advantage of federal incentives and adopt electronic health record (EHR) technology. Although CPOE is associated with a reduction in medical errors, when orders are placed electronically certain types of errors, including placing orders on the wrong patient, may occur more frequently.
Although there have been no studies quantifying (or even establishing) an increased risk of wrong-patient errors when providers have multiple records open at once, there have been several articles and expert opinions that warn of this potential risk.
The mechanism by which multiple patient records opened simultaneously can lead to a wrong-patient error may be related to the ease with which users can toggle between patient records and the similar looking computer screens. The magnitude of this risk needs to be established to help Information Technology (IT) leadership decide on how to safely implement CPOE systems.
There have been no studies demonstrating whether multiple records increase the risk of wrong-patient errors, by how much, and if any increase is dependent on the number of records open. This research project is an important first step in quantifying this risk.
In a randomized controlled trial conducted at Montefiore Medical Center, investigators propose to randomize inpatient and outpatient providers to a maximum of one record open at the time of ordering (restricted mode) or a maximum of four records open at the time of ordering (unrestricted mode).
Assignments will be made prior to the start of the study, and will remain constant throughout the study. A computer programmer working in IT, who is not an investigator of this study, will use Microsoft Excel to generate random numbers and assign one number to each provider. Providers assigned odd numbers will be in the restricted cohort, and those assigned even numbers will be in the unrestricted cohort. Providers who join Montefiore after the start of the study will be assigned a random number from Excel when assigned a new user log in for the EHR from a computer programmer not affiliated with the study, and will be added to the appropriate group based on their assigned random number. At the start of the randomized controlled trial, investigators will explain the purpose of the study to clinical staff via email and directly from within their IT systems, using a message crafted by the study team. The message will assure clinicians that data will be kept confidential and cooperation will carry no risk to them.
Montefiore uses the Epic Systems Corporation, or Epic, EHR system. Epic will implement the Retract-and-Reorder (RAR) tool, an automated method for identifying wrong-patient electronic orders, as well as capture the number of records open at the time of placing an order. This study will examine the effect of having the EHR system in restricted mode vs. unrestricted mode on RAR events. The goal is to obtain an estimate of the effect size and the intra-class correlations to provide preliminary data for a larger-scale health IT implementation research project. The unit of analysis will be the order. First, the RAR event rate for orders placed in the restricted vs. unrestricted mode will be calculated, testing the difference in rates using rank sum tests. Next, the relationship between the RAR event rate in restricted vs. unrestricted mode in subsets of providers and settings will be examined to determine whether specific types of providers or settings carry increased risk. Finally, a mixed-effects logistic regression model will be fitted with RAR event as the outcome and mode of the EHR system (restricted vs. unrestricted) as the independent variable of interest. The model will include random effects at the provider and order-session level because previous work has suggested substantial within-provider and within-session correlation. Orders will be nested in sessions and sessions will be nested in providers. To address the threat of confounding, the model will include fixed-effects variables including provider, patient, order-session, and order level covariates.
To safeguard against the possibility that the intervention actually worsens (increases) the RAR event rate, and to prevent unnecessary continuation of a study that is already conclusive, a data safety monitoring committee will conduct one interim review of the data in the randomized controlled trial.
Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Clinician Participant Inclusion Criteria:
-All clinicians (physicians, nurse practitioners, physician assistants) who placed electronic orders during the study period will be included in the study. (Randomization is at the level of the clinician.)
Clinician Exclusion Criteria:
Patient Record Inclusion Criteria:
-All inpatient, emergency department, and ambulatory patients for whom electronic orders were placed during the study period will be included in the study.
Users have "unrestricted" access to open up to a maximum of 4 patient records at a time in the EHR
Other: Unrestricted
Users have "restricted" access to open a maximum of 1 patient record at a time in the EHR
Other: Restricted
Users may open up to 4 patient records at a time.
Users are restricted to open 1 patient record at a time.
Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, As-randomized Analysis
The primary analysis included all order sessions performed by clinicians according to their assigned randomization group. The primary outcome was wrong-patient order sessions, defined as order sessions that include at least 1 wrong-patient Retract-and-Reorder (RAR) event. Wrong-patient order sessions were identified using the Wrong-Patient Retract-and-Reorder (RAR) measure. The Wrong-Patient RAR measure uses an electronic query to identify wrong-patient RAR events, defined as one or more orders placed for a patient that are retracted (cancelled) by the same provider within 10 minutes, and then reordered by the same provider for a different patient within the next 10 minutes.
Time frame: 19-month study period. All order sessions placed by randomized clinicians during the study period were included in the analysis. The time frame for each participant varied.
Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, as Treated Analysis
The outcome was wrong-patient order sessions, defined as order sessions that include at least 1 wrong-patient Retract-and-Reorder (RAR) event. In the as treat analysis, each order was characterized by the clinician's initial configuration at the time an order was placed. Wrong-patient order sessions were identified using the Wrong-Patient Retract-and-Reorder (RAR) measure. The Wrong-Patient RAR measure uses an electronic query to identify wrong-patient RAR events, defined as one or more orders placed for a patient that are retracted (cancelled) by the same provider within 10 minutes, and then reordered by the same provider for a different patient within the next 10 minutes.
Time frame: 19-month study period. All order sessions placed by randomized clinicians during the study period were included in the analysis. The time frame for each participant varied.
All clinicians who placed electronic orders during the study period at a large health system in New York in the emergency department (ED), inpatient, and outpatient settings.
| Milestone | Unrestricted | Restricted |
|---|---|---|
| Started | 1687 | 1669 |
| Received assigned intervention | 1556 | 1400 |
| Assigned to opposite group at start of trial period | 120 | 185 |
| Switched groups during trial period | 11 | 84 |
| Completed | 1687 | 1669 |
| Not completed | 0 | 0 |
The primary analysis included all order sessions performed by clinicians according to their assigned randomization group. The primary outcome was wrong-patient order sessions, defined as order sessions that include at least 1 wrong-patient Retract-and-Reorder (RAR) event. Wrong-patient order sessions were identified using the Wrong-Patient Retract-and-Reorder (RAR) measure. The Wrong-Patient RAR measure uses an electronic query to identify wrong-patient RAR events, defined as one or more orders placed for a patient that are retracted (cancelled) by the same provider within 10 minutes, and then reordered by the same provider for a different patient within the next 10 minutes.
| Wrong-patient order sessions | Unrestricted | Restricted |
|---|---|---|
| Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, As-randomized Analysis | 3015 | 3058 |
The outcome was wrong-patient order sessions, defined as order sessions that include at least 1 wrong-patient Retract-and-Reorder (RAR) event. In the as treat analysis, each order was characterized by the clinician's initial configuration at the time an order was placed. Wrong-patient order sessions were identified using the Wrong-Patient Retract-and-Reorder (RAR) measure. The Wrong-Patient RAR measure uses an electronic query to identify wrong-patient RAR events, defined as one or more orders placed for a patient that are retracted (cancelled) by the same provider within 10 minutes, and then reordered by the same provider for a different patient within the next 10 minutes.
| Wrong-patient order sessions | Unrestricted | Restricted |
|---|---|---|
| Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, as Treated Analysis | 3091 | 2982 |
The outcome measure was the rate of wrong-patient order sessions by the number of records open when orders were placed in the unrestricted group. Wrong-patient order sessions are defined as order sessions that include at least 1 wrong-patient Retract-and-Reorder (RAR) event. Wrong-patient order sessions were identified using the Wrong-Patient Retract-and-Reorder (RAR) measure. The Wrong-Patient RAR measure uses an electronic query to identify wrong-patient RAR events, defined as one or more orders placed for a patient that are retracted (cancelled) by the same provider within 10 minutes, and then reordered by the same provider for a different patient within the next 10 minutes. The outcome measure was reported as the number of wrong-patient order sessions per 100,000 order sessions.
| wrong order sessions / 100,000 sessions | Unrestricted, 1 Record Open | Unrestricted, 2 Records Open | Unrestricted, 3 Records Open | Unrestricted, 4 Records Open |
|---|---|---|---|---|
| Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, Unrestricted Group | 52.0 | 132.0 | 165.7 | 184.5 |
Collected over 19-month study period. The time frame for each participant varied.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unrestricted | 0/1,687 (0%) | 0/1,687 (0%) | 0/1,687 (0%) |
| Restricted | 0/1,669 (0%) | 0/1,669 (0%) | 0/1,669 (0%) |
Clinicians with the authority to place an electronic order during the study period. Clinicians were excluded if their workflow included: 1) required 2 open patient records simultaneously (e.g., mother-infant services), or 2) bypassed standard order entry process and could not be captured by the outcome measure (e.g., radiologist).
| Age, Continuous(years) | Unrestricted | Restricted | Total |
|---|---|---|---|
| Mean | 43.2 ± 12.3 | 42.9 ± 12.7 | 43.1 ± 12.5 |
| Sex: Female, Male(Participants) | Unrestricted | Restricted | Total |
|---|---|---|---|
| Female | 959 | 935 | 1894 |
| Male | 728 | 734 | 1462 |
| Race and Ethnicity Not Collected(Participants) | Unrestricted | Restricted | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Experience at Study Site(years) | Unrestricted | Restricted | Total |
|---|---|---|---|
| Mean | 6.6 ± 6.0 | 6.4 ± 6.0 | 6.5 ± 6.0 |
| Provider Type(Participants) | Unrestricted | Restricted | Total |
|---|---|---|---|
| Attending Physician | 814 | 806 | 1620 |
| House staff | 542 | 529 | 1071 |
| Mid-level | 331 | 334 | 665 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Research may request data from the PI (Jason Adelman). Partial, de-identified order data will be made available for research purposes for analyses approved by the researchers' Institutional Review Board and by the PI. Data will be made available upon approval.
Supporting information: Study protocol, Sap
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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