Dataset Information

Second Victim Support at the Core of Severe Adverse Event Investigation.

ABSTRACT: There is limited evidence and a lack of standard operating procedures to address the impact of serious adverse events (SAE) on healthcare workers. We aimed to share two years' experience of a second victim support intervention integrated into the SAE management program conducted in a 500-bed University Hospital in Granada, Spain. The intervention strategy, based on the "forYOU" model, was structured into three levels of support according to the degree of affliction and the emotional needs of the professionals. A semi-structured survey of all workers involved in an SAE was used to identify potential second victims. Between 2020 and 2021, the SAE operating procedure was activated 23 times. All healthcare workers involved in an SAE (n = 135) received second-level support. The majority were physicians (51.2%), followed by nurses (26.7%). Only 58 (43.0%) received first-level emotional support and 47 (34.8%) met "second victim" criteria. Seven workers (14.9%) required third-level support. A progressive increase in the notification rates was observed. Acceptance of the procedure by professionals and managers was high. This novel approach improved the number of workers reached by the trained staff; promoted the visibility of actions taken during SAE management and helped foster patient safety culture in our setting.

SUBMITTER: Cobos-Vargas A

PROVIDER: S-EPMC9779208 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Second Victim Support at the Core of Severe Adverse Event Investigation.

Cobos-Vargas Angel A Pérez-Pérez Pastora P Núñez-Núñez María M Casado-Fernández Eloísa E Bueno-Cavanillas Aurora A

International journal of environmental research and public health 20221215 24

There is limited evidence and a lack of standard operating procedures to address the impact of serious adverse events (SAE) on healthcare workers. We aimed to share two years' experience of a second victim support intervention integrated into the SAE management program conducted in a 500-bed University Hospital in Granada, Spain. The intervention strategy, based on the "forYOU" model, was structured into three levels of support according to the degree of affliction and the emotional needs of the ...[more]

PMID: 36554728

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Project description:BackgroundLumateperone has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia in adults since 2019, however, there is still a lack of data report on adverse reactions in real-world settings. Conducting data mining on adverse events (AEs) associated with Lumateperone and investigating the risk factors for serious AEs can provide valuable insights for its clinical practice.MethodsAE reports in the FDA Adverse Event Reporting System (FAERS) from 2019 Q4 (FDA approval of Lumateperone) to 2024 Q1 were collected and analyzed. Disproportionality in Lumateperone-associated AEs was evaluated using the following parameters: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Univariate and multivariate logistic regression analyses were conducted to identify the risk factors for Lumateperone-induced severe AEs.ResultsA total of 2,644 reports defined Lumateperone as the primary suspected drug was collected, including 739 reports classified as severe AEs and 1905 reports as non-severe AEs. The analysis revealed that 130 preferred terms (PTs) with significant disproportionality were based on the four algorithms, 67 (51.53%) of which were not included in the product labeling, affecting 6 systems and organs. In addition, dizziness (81 cases) was the most reported Lumateperone-associated severe AEs, and tardive dyskinesia showed the strongest signal (ROR = 186.24). Logistic regression analysis indicated that gender, bipolar II disorder, and concomitant drug use are independent risk factors for Lumateperone-associated severe AEs. Specifically, female patients had a 1.811-fold increased risk compared with male patients (OR = 1.811 [1.302, 2.519], p = 0.000), while patients with bipolar II disorder had a 1.695-fold increased risk compared with patients diagnosed with bipolar disorder (OR = 1.695 [1.320, 2.178], p = 0.000). Conversely, concomitant use of CYP3A4 inhibitors or drugs metabolized by CYP3A4 was associated with a decreased risk of severe AEs (OR = 0.524 [0.434, 0.633], P = 0.000).ConclusionCollectively, this study provides critical insights into the safety profile of Lumateperone. It highlights the need for cautious use in high-risk populations, such as females and individuals with bipolar II disorder, and emphasizes the importance of monitoring for AEs, including dizziness and tardive dyskinesia. Healthcare also should remain alert to potential AEs not listed in the prescribing information to ensure medical safety.

Project description:BackgroundPsychological support programs can help nurses who involved in patient safety incidents. However, most of these programs are operated internally by healthcare providers and utilize peer supporters, which may take a long time to implement. Therefore, there is a need to develop programs that can be used by healthcare providers in healthcare institutions that have difficulty implementing their own programs. This feasibility study aimed to develop an external support program for nurses as second victims and to examine the feasibility, acceptability, and impact of the program.MethodsThis study was conducted using a single-group pretest-posttest design. Nurses who experienced patient safety incidents were recruited through posters at three advanced general hospitals, as well as open online recruitment and via a research agency panel from September 2020 to April 2021. The 11 participants attended a total of three one-on-one counseling sessions. Feasibility was evaluated based on participant recruitment and retention, resource availability, program procedures, and the practicability of data collection. Acceptability was assessed through program satisfaction and participant feedback. Psychological impact was measured using the Impact of Event Scale-Revised Korean version.ResultsOut of 26 applicants, 11 (42.3%) completed the program, with 10 (38.5%) participants completing both pre and post-program surveys. Most participants responded that they were satisfied with the program and expressed their intention to recommend the program to others and participate in it again if similar situations arise. The participants' median total IES-R-K score decreased significantly from 30.0 to 16.0 (p = 0.028, r = 0.67).ConclusionThis study demonstrates the feasibility of an external second victim support program and provides preliminary data suggesting its potential to alleviate the psychological impact of participants. To overcome the limitations of this study, it is necessary to conduct additional controlled trials with a longer follow-up period and a larger sample size.

Dataset Information

Second Victim Support at the Core of Severe Adverse Event Investigation.

Publications

Second Victim Support at the Core of Severe Adverse Event Investigation.

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