Risk of Wrong-Patient Errors With Multiple Records Open

NCT02876588 | Completed Results DMC

• 2 other identifiers: AAAQ9954R21HS023704
• Study Type: interventional
• Target: 3,356
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to achieve the following aims:

1. 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. 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. 3.The results of this study will help inform decisions on how to safely implement EHR systems.
4. 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.

Conditions

Medical Errors; Medical Order Entry Systems

Keywords

Wrong-Patient Errors; Retract-and-Reorder measure

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (1)

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

  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.

Study Arms (2)

Unrestricted

ACTIVE COMPARATOR

Users have "unrestricted" access to open up to a maximum of 4 patient records at a time in the EHR

Other: Unrestricted

Restricted

ACTIVE COMPARATOR

Users have "restricted" access to open a maximum of 1 patient record at a time in the EHR

Other: Restricted

Interventions

Unrestricted OTHER

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

Unrestricted

Restricted OTHER

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

Restricted

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• \- Clinicians whose workflow requires access to more than one patient record at a time.
• All inpatient, emergency department, and ambulatory patients for whom electronic orders were placed during the study period will be included in the study.

Sponsors & Collaborators

• Columbia University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (9)

• Adelman J, Aschner J, Schechter C, Angert R, Weiss J, Rai A, Berger M, Reissman S, Parakkattu V, Chacko B, Racine A, Southern W. Use of Temporary Names for Newborns and Associated Risks. Pediatrics. 2015 Aug;136(2):327-33. doi: 10.1542/peds.2015-0007. Epub 2015 Jul 13.

  PMID: 26169429 BACKGROUND

• Adelman JS, Kalkut GE, Schechter CB, Weiss JM, Berger MA, Reissman SH, Cohen HW, Lorenzen SJ, Burack DA, Southern WN. Understanding and preventing wrong-patient electronic orders: a randomized controlled trial. J Am Med Inform Assoc. 2013 Mar-Apr;20(2):305-10. doi: 10.1136/amiajnl-2012-001055. Epub 2012 Jun 29.

  PMID: 22753810 BACKGROUND

• Adelman JS, Aschner JL, Schechter CB, Angert RM, Weiss JM, Rai A, Parakkattu V, Goffman D, Applebaum JR, Racine AD, Southern WN. Babyboy/Babygirl: A National Survey on the Use of Temporary, Nondistinct Naming Conventions for Newborns in Neonatal Intensive Care Units. Clin Pediatr (Phila). 2017 Oct;56(12):1157-1159. doi: 10.1177/0009922817701178. Epub 2017 Apr 12. No abstract available.

  PMID: 28403654 BACKGROUND

• Adelman JS, Berger MA, Rai A, Galanter WL, Lambert BL, Schiff GD, Vawdrey DK, Green RA, Salmasian H, Koppel R, Schechter CB, Applebaum JR, Southern WN. A national survey assessing the number of records allowed open in electronic health records at hospitals and ambulatory sites. J Am Med Inform Assoc. 2017 Sep 1;24(5):992-995. doi: 10.1093/jamia/ocx034.

  PMID: 28419267 BACKGROUND

• Adelman JS, Aschner JL, Schechter CB, Angert RM, Weiss JM, Rai A, Berger MA, Reissman SH, Yongue C, Chacko B, Dadlez NM, Applebaum JR, Racine AD, Southern WN. Evaluating Serial Strategies for Preventing Wrong-Patient Orders in the NICU. Pediatrics. 2017 May;139(5):e20162863. doi: 10.1542/peds.2016-2863.

  PMID: 28557730 BACKGROUND

• Kannampallil TG, Manning JD, Chestek DW, Adelman J, Salmasian H, Lambert BL, Galanter WL. Effect of number of open charts on intercepted wrong-patient medication orders in an emergency department. J Am Med Inform Assoc. 2018 Jun 1;25(6):739-743. doi: 10.1093/jamia/ocx099.

  PMID: 29025090 BACKGROUND

• Wachter RM, Murray SG, Adler-Milstein J. Restricting the Number of Open Patient Records in the Electronic Health Record: Is the Record Half Open or Half Closed? JAMA. 2019 May 14;321(18):1771-1773. doi: 10.1001/jama.2019.3835. No abstract available.

  PMID: 31087007 BACKGROUND

• Adelman JS, Applebaum JR, Schechter CB, Berger MA, Reissman SH, Thota R, Racine AD, Vawdrey DK, Green RA, Salmasian H, Schiff GD, Wright A, Landman A, Bates DW, Koppel R, Galanter WL, Lambert BL, Paparella S, Southern WN. Effect of Restriction of the Number of Concurrently Open Records in an Electronic Health Record on Wrong-Patient Order Errors: A Randomized Clinical Trial. JAMA. 2019 May 14;321(18):1780-1787. doi: 10.1001/jama.2019.3698.

  PMID: 31087021 RESULT

• Southern WN, Applebaum JR, Salmasian H, Kneifati-Hayek J, Carter EJ, Sumner JA, Adelman JS. Clinician Experience of Electronic Health Record Configurations Displaying 1 vs 4 Records at a Time. JAMA Intern Med. 2019 Dec 1;179(12):1723-1725. doi: 10.1001/jamainternmed.2019.3688.

  PMID: 31524923 DERIVED

Limitations and Caveats

The outcome measure (Wrong-patient RAR measure) captures only one type of wrong-patient error; the study was conducted in a single health system and EHR platform, and therefore results may not be generalizable.

Results Point of Contact

• Title: Dr. Jason Adelman
• Organization: Columbia University

adelman.jason@columbia.edu

646-317-4803

Study Officials

• Jason Adelman, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 24, 2016
• Study Start: October 1, 2015
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon publication of results.
• Access Criteria: 1. Approval by the researchers' Institutional Review Board. 2. Approval by the PI.

Locations

US (1)