Clinical trial NCT02876588: Risk of Wrong-Patient Errors With Multiple Records Open
Official title: Assessing the Risk of Wrong-Patient Errors in an Electronic Health Record That Allows Multiple Records Open
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Errors
Medical Order Entry Systems
Keywords: Wrong-Patient Errors
Retract-and-Reorder measure
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2016-08-24
Enrollment: 3356
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, As-randomized Analysis
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.
Secondary outcomes:
measure: Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, as Treated Analysis
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.
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Jason Adelman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.