Trial Outcomes & Findings for Risk of Wrong-Patient Errors With Multiple Records Open (NCT NCT02876588)

NCT ID: NCT02876588

Last Updated: 2025-02-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3356 participants

Primary outcome timeframe

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.

Results posted on

2025-02-10

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure
Unrestricted
Users have "unrestricted" access to open a maximum of 4 patient records at a time in the Electronic Health Record (EHR)
Restricted
Users have "restricted" access to open a maximum of 1 patient record at a time in the EHR
Overall Study
STARTED
1687
1669
Overall Study
Received Assigned Intervention
1556
1400
Overall Study
Assigned to Opposite Group at Start of Trial Period
120
185
Overall Study
Switched Groups During Trial Period
11
84
Overall Study
COMPLETED
1687
1669
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Unrestricted
n=1687 Participants
Users have "unrestricted" access to open a maximum of 4 patient records at a time in the EHR
Restricted
n=1669 Participants
Users have "restricted" access to open a maximum of 1 patient record at a time in the EHR
Total
n=3356 Participants
Total of all reporting groups
Age, Continuous
43.2 years
STANDARD_DEVIATION 12.3 • n=1687 Participants
42.9 years
STANDARD_DEVIATION 12.7 • n=1669 Participants
43.1 years
STANDARD_DEVIATION 12.5 • n=3356 Participants
Sex: Female, Male
Female
959 Participants
n=1687 Participants
935 Participants
n=1669 Participants
1894 Participants
n=3356 Participants
Sex: Female, Male
Male
728 Participants
n=1687 Participants
734 Participants
n=1669 Participants
1462 Participants
n=3356 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Experience at Study Site
6.6 years
STANDARD_DEVIATION 6.0 • n=1687 Participants
6.4 years
STANDARD_DEVIATION 6.0 • n=1669 Participants
6.5 years
STANDARD_DEVIATION 6.0 • n=3356 Participants
Provider Type
Attending Physician
814 Participants
n=1687 Participants
806 Participants
n=1669 Participants
1620 Participants
n=3356 Participants
Provider Type
House staff
542 Participants
n=1687 Participants
529 Participants
n=1669 Participants
1071 Participants
n=3356 Participants
Provider Type
Mid-level
331 Participants
n=1687 Participants
334 Participants
n=1669 Participants
665 Participants
n=3356 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Unrestricted
n=6283306 Order sessions
Users have "unrestricted" access to open up to a maximum of 4 patient records at a time in the EHR Unrestricted: Users may open up to 4 patient records at a time.
Restricted
n=5856992 Order sessions
Users have "restricted" access to open a maximum of 1 patient record at a time in the EHR Restricted: Users are restricted to open 1 patient record at a time.
Unrestricted, 3 Records Open
Users have "unrestricted" access to open up to a maximum of 4 patient records at a time in the EHR Unrestricted, 1 record open: Users only opened 3 records at a time
Unrestricted, 4 Records Open
Users have "unrestricted" access to open up to a maximum of 4 patient records at a time in the EHR Unrestricted, 4 records open: Users opened up to 4 records 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
3015 Wrong-patient order sessions
3058 Wrong-patient order sessions

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Unrestricted
n=6415909 Order sessions
Users have "unrestricted" access to open up to a maximum of 4 patient records at a time in the EHR Unrestricted: Users may open up to 4 patient records at a time.
Restricted
n=5724389 Order sessions
Users have "restricted" access to open a maximum of 1 patient record at a time in the EHR Restricted: Users are restricted to open 1 patient record at a time.
Unrestricted, 3 Records Open
Users have "unrestricted" access to open up to a maximum of 4 patient records at a time in the EHR Unrestricted, 1 record open: Users only opened 3 records at a time
Unrestricted, 4 Records Open
Users have "unrestricted" access to open up to a maximum of 4 patient records at a time in the EHR Unrestricted, 4 records open: Users opened up to 4 records at a time
Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, as Treated Analysis
3091 Wrong-patient order sessions
2982 Wrong-patient order sessions

POST_HOC outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Unrestricted
n=1523585 Order sessions
Users have "unrestricted" access to open up to a maximum of 4 patient records at a time in the EHR Unrestricted: Users may open up to 4 patient records at a time.
Restricted
n=303080 Order sessions
Users have "restricted" access to open a maximum of 1 patient record at a time in the EHR Restricted: Users are restricted to open 1 patient record at a time.
Unrestricted, 3 Records Open
n=168387 Order sessions
Users have "unrestricted" access to open up to a maximum of 4 patient records at a time in the EHR Unrestricted, 1 record open: Users only opened 3 records at a time
Unrestricted, 4 Records Open
n=267697 Order sessions
Users have "unrestricted" access to open up to a maximum of 4 patient records at a time in the EHR Unrestricted, 4 records open: Users opened up to 4 records at a time
Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, Unrestricted Group
52.0 wrong order sessions / 100,000 sessions
132.0 wrong order sessions / 100,000 sessions
165.7 wrong order sessions / 100,000 sessions
184.5 wrong order sessions / 100,000 sessions

Adverse Events

Unrestricted

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Restricted

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jason Adelman

Columbia University

Phone: 646-317-4803

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place