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      Effectiveness of a ‘do not interrupt’ vest intervention to reduce medication errors during medication administration: a multicenter cluster randomized controlled trial

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          Abstract

          Background

          The use of a ‘do not interrupt’ vest during medication administration rounds is recommended but there have been no controlled randomized studies to evaluate its impact on reducing administration errors. We aimed to evaluate the impact of wearing such a vest on reducing such errors. The secondary objectives were to evaluate the types and potential clinical impact of errors, the association between errors and several risk factors (such as interruptions), and nurses’ experiences.

          Methods

          This was a multicenter, cluster, controlled, randomized study (March–July 2017) in 29 adult units (4 hospitals). Data were collected by direct observation by trained observers. All nurses from selected units were informed. A ‘Do not interrupt’ vest was implemented in all units of the experimental group. A poster was placed at the entrance of these units to inform patients and relatives. The main outcome was the administration error rate (number of Opportunities for Error (OE), calculated as one or more errors divided by the Total Opportunities for Error (TOE) and multiplied by 100).

          Results

          We enrolled 178 nurses and 1346 patients during 383 medication rounds in 14 units in the experimental group and 15 units in the control group. During the intervention period, the administration error rates were 7.09% (188 OE with at least one error/2653 TOE) for the experimental group and 6.23% (210 OE with at least one error/3373 TOE) for the control group ( p = 0.192). Identified risk factors (patient age, nurses’ experience, nurses’ workload, unit exposition, and interruption) were not associated with the error rate. The main error type observed for both groups was wrong dosage-form. Most errors had no clinical impact for the patient and the interruption rates were 15.04% for the experimental group and 20.75% for the control group.

          Conclusions

          The intervention vest had no impact on medication administration error or interruption rates. Further studies need to be performed taking into consideration the limitations of our study and other risk factors associated with other interventions, such as nurse’s training and/or a barcode system.

          Trial registration

          The PERMIS study protocol (V2–1, 11/04/2017) was approved by institutional review boards and ethics committees (CPP Ile de France number 2016-A00211–50, CNIL 21/03/2017, CCTIRS 11/04/2016). It is registered at ClinicalTrials.gov (registration number: NCT03062852, date of first registration: 23/02/2017).

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12912-021-00671-7.

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          Most cited references41

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          Designing Difference in Difference Studies: Best Practices for Public Health Policy Research

          The difference in difference (DID) design is a quasi-experimental research design that researchers often use to study causal relationships in public health settings where randomized controlled trials (RCTs) are infeasible or unethical. However, causal inference poses many challenges in DID designs. In this article, we review key features of DID designs with an emphasis on public health policy research. Contemporary researchers should take an active approach to the design of DID studies, seeking to construct comparison groups, sensitivity analyses, and robustness checks that help validate the method's assumptions. We explain the key assumptions of the design and discuss analytic tactics, supplementary analysis, and approaches to statistical inference that are often important in applied research. The DID design is not a perfect substitute for randomized experiments, but it often represents a feasible way to learn about casual relationships. We conclude by noting that combining elements from multiple quasi-experimental techniques may be important in the next wave of innovations to the DID approach.
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            Association of interruptions with an increased risk and severity of medication administration errors.

            Interruptions have been implicated as a cause of clinical errors, yet, to our knowledge, no empirical studies of this relationship exist. We tested the hypothesis that interruptions during medication administration increase errors. We performed an observational study of nurses preparing and administering medications in 6 wards at 2 major teaching hospitals in Sydney, Australia. Procedural failures and interruptions were recorded during direct observation. Clinical errors were identified by comparing observational data with patients' medication charts. A volunteer sample of 98 nurses (representing a participation rate of 82%) were observed preparing and administering 4271 medications to 720 patients over 505 hours from September 2006 through March 2008. Associations between procedural failures (10 indicators; eg, aseptic technique) and clinical errors (12 indicators; eg, wrong dose) and interruptions, and between interruptions and potential severity of failures and errors, were the main outcome measures. Each interruption was associated with a 12.1% increase in procedural failures and a 12.7% increase in clinical errors. The association between interruptions and clinical errors was independent of hospital and nurse characteristics. Interruptions occurred in 53.1% of administrations (95% confidence interval [CI], 51.6%-54.6%). Of total drug administrations, 74.4% (n = 3177) had at least 1 procedural failure (95% CI, 73.1%-75.7%). Administrations with no interruptions (n = 2005) had a procedural failure rate of 69.6% (n = 1395; 95% CI, 67.6%-71.6%), which increased to 84.6% (n = 148; 95% CI, 79.2%-89.9%) with 3 interruptions. Overall, 25.0% (n = 1067; 95% CI, 23.7%-26.3%) of administrations had at least 1 clinical error. Those with no interruptions had a rate of 25.3% (n = 507; 95% CI, 23.4%-27.2%), whereas those with 3 interruptions had a rate of 38.9% (n = 68; 95% CI, 31.6%-46.1%). Nurse experience provided no protection against making a clinical error and was associated with higher procedural failure rates. Error severity increased with interruption frequency. Without interruption, the estimated risk of a major error was 2.3%; with 4 interruptions this risk doubled to 4.7% (95% CI, 2.9%-7.4%; P < .001). Among nurses at 2 hospitals, the occurrence and frequency of interruptions were significantly associated with the incidence of procedural failures and clinical errors.
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              The impact of interruptions on clinical task completion.

              Interruptions and multitasking are implicated as a major cause of clinical inefficiency and error. The aim was to measure the association between emergency doctors' rates of interruption and task completion times and rates. The authors conducted a prospective observational time and motion study in the emergency department of a 400-bed teaching hospital. Forty doctors (91% of medical staff) were observed for 210.45 h on weekdays. The authors calculated the time on task (TOT); the relationship between TOT and interruptions; and the proportion of time in work task categories. Length-biased sampling was controlled for. Doctors were interrupted 6.6 times/h. 11% of all tasks were interrupted, 3.3% more than once. Doctors multitasked for 12.8% of time. The mean TOT was 1:26 min. Interruptions were associated with a significant increase in TOT. However, when length-biased sampling was accounted for, interrupted tasks were unexpectedly completed in a shorter time than uninterrupted tasks. Doctors failed to return to 18.5% (95% CI 15.9% to 21.1%) of interrupted tasks. It appears that in busy interrupt-driven clinical environments, clinicians reduce the time they spend on clinical tasks if they experience interruptions, and may delay or fail to return to a significant portion of interrupted tasks. Task shortening may occur because interrupted tasks are truncated to 'catch up' for lost time, which may have significant implications for patient safety.
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                Author and article information

                Contributors
                sarah.berdot@aphp.fr
                aurelie.vilfaillot@aphp.fr
                ybezie@hpsj.fr
                germain.perrin@aphp.fr
                marion.berge@aphp.fr
                jcorny@hpsj.fr
                TTPhanThi@hpsj.fr
                mathieu.depoisson@aphp.fr
                claudine.guihaire@aphp.fr
                nathalie.valin@aphp.fr
                claudine.decelle@aphp.fr
                alexandre.karras@aphp.fr
                pierdurieux@gmail.com
                laetitia.le@aphp.fr
                brigitte.sabatier@aphp.fr
                Journal
                BMC Nurs
                BMC Nurs
                BMC Nursing
                BioMed Central (London )
                1472-6955
                24 August 2021
                24 August 2021
                2021
                : 20
                : 153
                Affiliations
                [1 ]GRID grid.414093.b, Pharmacy Department, , Hôpital européen Georges-Pompidou, APHP, ; 20 rue Leblanc, 75015 Paris, France
                [2 ]GRID grid.10988.38, ISNI 0000 0001 2173 743X, INSERM, UMRS1138, Centre de Recherche des Cordeliers, Sorbonne Université, Université de Paris, ; Paris, France
                [3 ]GRID grid.414093.b, Clinical Research Department, , Hôpital européen Georges-Pompidou, APHP, ; 20 rue Leblanc, 75015 Paris, France
                [4 ]Pharmacy Department, Paris Saint Joseph Hôpital, Paris, France
                [5 ]GRID grid.50550.35, ISNI 0000 0001 2175 4109, Pharmacy Department, , Hôpital Vaugirard and Hôpital Corentin Celton, APHP, ; Paris, France
                [6 ]GRID grid.414093.b, DSAP, Hôpital européen Georges-Pompidou, APHP, 20 rue Leblanc, 75015, ; Paris, France
                [7 ]GRID grid.414093.b, Department of Nephrology, , Hôpital européen Georges-Pompidou, APHP, 20 rue Leblanc, 75015, ; Paris, France
                [8 ]GRID grid.508487.6, ISNI 0000 0004 7885 7602, Paris Descartes University, ; Paris, France
                [9 ]GRID grid.462416.3, ISNI 0000 0004 0495 1460, INSERM, PARCC, ; Paris, France
                [10 ]GRID grid.460789.4, ISNI 0000 0004 4910 6535, Lip(Sys)2, EA7357, UFR Pharmacie, U-Psud, , University of Paris-Saclay, ; Paris, France
                Article
                671
                10.1186/s12912-021-00671-7
                8383384
                34429095
                347f1457-5f23-4578-8952-de3283d9c369
                © The Author(s) 2021

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 19 March 2021
                : 16 July 2021
                Categories
                Research
                Custom metadata
                © The Author(s) 2021

                Nursing
                interruptions,vest,medication errors/nursing* (mesh),medication errors/prevention and control (mesh),nursing staff,hospital / organization & administration (mesh),safety management / organization & administration* (mesh)

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