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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05424497
Other study ID # N22.025
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 16, 2022
Est. completion date December 31, 2023

Study information

Verified date June 2022
Source Maxima Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background Hindsight bias and outcome bias may play an important role in retrospective law of errors in Emergency Medicine and may affect judgement. In addition, differences in sex and medical history may affect treatment decisions (implicit bias). Aims First, to assess if and to what extent knowledge of an outcome may affect the ability of Emergency Physicians and physicians with experience in disciplinary law to determine the quality of care given. Secondly, to investigate whether a medical history with nonspecific/functional/somatoform complaints and sex differences affect clinical decision making in Emergency Physicians. Study design and analyses A web-based cross-sectional survey using vignettes with six clinical scenarios (four vignettes for outcome/hindsight bias, four vignettes for implicit bias). The survey was sent to all Emergency Physicians and residents in training in the Netherlands. Four scenarios were also sent to physicians with experience in disciplinary law. In four vignettes, participants received a scenario without an outcome, or with a positive or negative outcome. They were asked to rate the quality of care provided as sufficient or insufficient and, in more detail, poor/below average/average/good/outstanding and how likely they thought it would be that the patient would have had a negative outcome (in percent). In the other two vignettes, participants received one vignette describing a scenario of a patient presenting to the ED with acute abdominal pain and one vignette describing a scenario with chest pain. The sex and medical history differed among the participants (e.g. male/female, nonspecific medical history/somatic medical history). Participants were asked whether they would prescribe pain medication, and whether they would do diagnostic imaging. Importance and impact This research may help to understand the impact of knowing the outcome in retrospective laws in Dutch Emergency Physicians and physicians with experience in disciplinary law. If outcome and hindsight bias are present, retrospective judgement may need a different approach in medicine, i.e. blinding judges for the outcome, to prevent wrong justice and adverse effect on clinicians well-being. Also, if implicit bias in sex and medical history is present, a training programme is needed to reduce certain bias and to improve equality in the provided care.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 350
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Emergency physicians or residents, General practitioners, and physicians with experience in disciplinary law. Exclusion Criteria: - others

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Vignettes
Presenting vignettes with fictive cases

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Maxima Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of care The quality of care rated on a likert scale from 1 to 5 will be assessed for 4 fictive cases. The mean will be compared for each case without outcome, with positive outcome, and with negative outcome. Throughout the study, 1day
Primary Diagnostic imaging Whether the physician would perform diagnostic imaging after reading the vignette. The The outcome will be compared for vignettes including a somatic medical history with the vignettes with a nonsomatic medical history. Throughout the study, 1day
Secondary Hindsight bias The estimate of the chance of getting the negative outcome (0 to 100%). Compared between the group of vignettes without outcome, with a positive outcome and with a negative outcome. Throughout the study, 1day
Secondary Pain medication Whether pain medication is prescribed (y/n) and how many milligrams. Compared between group of patients with somatic medical history and nonsomatic medical history. Throughout the study, 1day
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