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Risk of Wrong-Patient Errors With Multiple Records Open

Assessing the Risk of Wrong-Patient Errors in an Electronic Health Record That Allows Multiple Records Open

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02876588
Enrollment
3356
Registered
2016-08-24
Start date
2015-10-01
Completion date
2017-04-30
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Errors, Medical Order Entry Systems

Keywords

Wrong-Patient Errors, Retract-and-Reorder measure

Brief summary

This study is designed to achieve the following aims: 1. Assess the relationship between the number of records open at the time of placing an order, and the risk of placing an order on the wrong patient. 2. Compare the incidence of wrong-patient orders in a restricted environment that limits its providers to only one record open at a time to an unrestricted environment where users can open a maximum of four records at once. 3. The results of this study will help inform decisions on how to safely implement EHR systems. 4. The results of this study will inform a larger scale health IT implementation research project evaluating the balance between the wrong-patient error risks and potential efficiency gains of having multiple records open at once, with rigorous research methodologies.

Detailed description

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.

Interventions

OTHERUnrestricted

Users may open up to 4 patient records at a time.

Users are restricted to open 1 patient record at a time.

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

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

\- Clinicians whose workflow requires access to more than one patient record at a time. 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.

Design outcomes

Primary

MeasureTime frameDescription
Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, As-randomized Analysis19-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.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.

Secondary

MeasureTime frameDescription
Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, as Treated Analysis19-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.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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

Clinicians were excluded if their workflow included: 1) required 2 open patient records simultaneously (eg, mother-infant services), or 2) bypassed standard order entry process and could not be captured by the outcome measure (eg, radiologist).

Participants by arm

ArmCount
Unrestricted
Users have unrestricted access to open a maximum of 4 patient records at a time in the EHR
1,687
Restricted
Users have restricted access to open a maximum of 1 patient record at a time in the EHR
1,669
Total3,356

Baseline characteristics

CharacteristicUnrestrictedRestrictedTotal
Age, Continuous43.2 years
STANDARD_DEVIATION 12.3
42.9 years
STANDARD_DEVIATION 12.7
43.1 years
STANDARD_DEVIATION 12.5
Experience at Study Site6.6 years
STANDARD_DEVIATION 6
6.4 years
STANDARD_DEVIATION 6
6.5 years
STANDARD_DEVIATION 6
Provider Type
Attending Physician
814 Participants806 Participants1620 Participants
Provider Type
House staff
542 Participants529 Participants1071 Participants
Provider Type
Mid-level
331 Participants334 Participants665 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
959 Participants935 Participants1894 Participants
Sex: Female, Male
Male
728 Participants734 Participants1462 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1,6870 / 1,669
other
Total, other adverse events
0 / 1,6870 / 1,669
serious
Total, serious adverse events
0 / 1,6870 / 1,669

Outcome results

Primary

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.

Population: All clinicians with the authority to place an electronic order during the study period, grouped by their assigned randomization. Clinicians were excluded if their workflow: 1) required 2 open patient records simultaneously (eg, mother-infant services), or 2) bypassed standard order entry process and could not be captured by the outcome measure (eg, radiologist).

ArmMeasureValue (NUMBER)
UnrestrictedWrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, As-randomized Analysis3015 Wrong-patient order sessions
RestrictedWrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, As-randomized Analysis3058 Wrong-patient order sessions
p-value: 0.695% CI: [0.9, 1.2]Regression, Logistic
Secondary

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.

Population: Clinicians were grouped according to their configuration at the time an electronic order was placed. Clinicians were excluded if their workflow: 1) required 2 open patient records simultaneously (eg, mother-infant services), or 2) bypassed standard order entry process and could not be captured by the outcome measure (eg, radiologist).

ArmMeasureValue (NUMBER)
UnrestrictedWrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, as Treated Analysis3091 Wrong-patient order sessions
RestrictedWrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, as Treated Analysis2982 Wrong-patient order sessions
p-value: 0.6895% CI: [0.89, 1.19]Regression, Logistic
Post Hoc

Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, Unrestricted Group

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.

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.

Population: All 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 (eg, mother-infant services), or 2) bypassed standard order entry process and could not be captured by the outcome measure (eg, radiologist).

ArmMeasureValue (NUMBER)
UnrestrictedWrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, Unrestricted Group52.0 wrong order sessions / 100,000 sessions
RestrictedWrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, Unrestricted Group132.0 wrong order sessions / 100,000 sessions
Unrestricted, 3 Records OpenWrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, Unrestricted Group165.7 wrong order sessions / 100,000 sessions
Unrestricted, 4 Records OpenWrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, Unrestricted Group184.5 wrong order sessions / 100,000 sessions
p-value: <0.001Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026