NCT02876588

Risk of Wrong-Patient Errors With Multiple Records Open

Completed NA Results posted Last updated 10 February 2025

What this trial tests

NA trial testing Unrestricted in Medical Errors in 3,356 participants. Completed in 30 April 2017.

Timeline

1 October 2015

Primary endpoint
30 April 2017

30 April 2017

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	3,356
Start date	1 October 2015
Primary completion	30 April 2017
Estimated completion	30 April 2017
Sites	1 location across United States

Drugs / interventions tested

• Unrestricted
• Restricted

Conditions studied

• Medical Errors — all drugs for Medical Errors →
• Medical Order Entry Systems — all drugs for Medical Order Entry Systems →

Sponsor

Columbia University

Who can join

Adults 21 to 100, any sex, with Medical Errors or Medical Order Entry Systems. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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 the

Group	Value	95% CI
Unrestricted	3015
Restricted	3058

Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, as Treated Analysis Secondary · 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.

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

Group	Value	95% CI
Unrestricted	3091
Restricted	2982

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

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

Group	Value	95% CI
Unrestricted, 1 Record Open	52.0
Unrestricted, 2 Records Open	132.0
Unrestricted, 3 Records Open	165.7
Unrestricted, 4 Records Open	184.5

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Reducing medication errors for adults in hospital settings.
   Ciapponi A, Fernandez Nievas SE, Seijo M, Rodríguez MB, et al · · 2021 · cited 41× · PMID 34822165 · DOI 10.1002/14651858.cd009985.pub2
2. Effect of Restriction of the Number of Concurrently Open Records in an Electronic Health Record on Wrong-Patient Order Errors: A Randomized Clinical Trial.
   Adelman JS, Applebaum JR, Schechter CB, Berger MA, et al · · 2019 · cited 30× · PMID 31087021 · DOI 10.1001/jama.2019.3698
3. Clinician Experience of Electronic Health Record Configurations Displaying 1 vs 4 Records at a Time.
   Southern WN, Applebaum JR, Salmasian H, Kneifati-Hayek J, et al · · 2019 · cited 3× · PMID 31524923 · DOI 10.1001/jamainternmed.2019.3688
4. Effect of restricting electronic health records on clinician efficiency: substudy of a randomized clinical trial.
   Kneifati-Hayek JZ, Applebaum JR, Schechter CB, Dal Col A, et al · · 2023 · cited 2× · PMID 37011638 · DOI 10.1093/jamia/ocad025