- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04123015
Clinical Activity During Night-shift: an Ecological Study
Study Overview
Status
Detailed Description
Various medical problems of patients admitted to an internal medicine ward can worsen during the stay. Furthermore, new, unidentified problems can develop (complications, medication errors, delirium, acute anxiety or pain, etc). During evenings, nights and week-ends, emergent needs of hospitalized patients are usually cared for by physicians in-training, who are in charge of a large number of patients. Hence, physicians should have a wide range of medical knowledge and procedural skills and know how acute problems are dealt with in the unique environment of the healthcare institution. Training physicians should also be able to obtain information and counseling efficiently, either from clinical guidelines, senior supervisors, or specialists.
These requirements may represent a significant stress for training physicians and may have a major impact on their health, quality of life, and finally on the quality of inpatient care. Nightshift work may lead later to a high burden of regrets among caregivers.
Better knowledge of training needs, organization features, coping strategies, and regrets associated with nightshift duty are important to prepare training physicians to that demanding and necessary task. Understanding of the epidemiology of night-shift ward emergencies could provide guidance concerning the required level of staffing and training of the responding medical team.
Furthermore, efficient transmission of information between day and night staff (so-called handoffs) is a difficult yet important part of care. Systematic observation of handoff sessions between physicians before and after nightshifts may enhance previous knowledge on key components of these topics.
The investigators will evaluate the incidence causes, and prognosis of night-shift emergencies in internal medicine wards by direct observation of the nightshift work of a convenient sample of internal medicine residents. By the means of before-and-after shift completion of various validated questionnaires, the investigators will explore quantitatively and qualitatively the physiological and psychological impact on nightshift work for physicians in training.
The planned study will also provide qualitative and quantitative data concerning handoffs session, and the repercussions on night shift emergencies management.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Geneva, Switzerland, 1205
- Geneva University Hospitals
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- resident in training in the internal medicine department, involved in one or more nightshift during the study
Exclusion Criteria:
- unwilling to participate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of nightshift interventions
Time Frame: 12 hours
|
12 hours
|
|
|
% of patients with nightshift interventions of different intensity
Time Frame: 12 hours
|
Rated on an ad-hoc scale (from "phone intervention only" to "active resuscitation")
|
12 hours
|
|
% of patients with different causes of nightshift interventions
Time Frame: 12 hours
|
Rated on an ad-hoc scale listing the different causes (e.g.
acute confusion; chest pain, etc)
|
12 hours
|
|
Incidence of selected outcomes of nightshift intervention
Time Frame: 24 hours
|
Rated on an ad-hoc scale (from "death" to "problem resolves without further intervention"
|
24 hours
|
|
Incidence of specific interventions during nightshift
Time Frame: 12 hours
|
Rated on an ad-hoc list, from "Provision of CPR or intubation" to "Prescription of any new drug"
|
12 hours
|
|
Incidence of predictable nightshift emergencies
Time Frame: 12 hours
|
Rated on an ad-hoc scale, from "Unexpected" to "Expected"
|
12 hours
|
|
Incidence of preventable nightshift emergencies
Time Frame: 12 hours
|
Rated on an ad-hoc scale, from "Unpreventable" to "Very likely preventable"
|
12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of sleep problems in nightshift residents
Time Frame: 30 days
|
30 days
|
|
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severity of sleep problems in nightshift residents
Time Frame: 30 days
|
measured with the insomnia severity index questionnaire, ISI
|
30 days
|
|
incidence of stress symptoms in nightshift residents
Time Frame: 30 days
|
30 days
|
|
|
severity of stress symptoms in nightshift residents
Time Frame: 30 days
|
Measured with an ad hoc scale (From "no stress at all" to "intense stress most of the time")
|
30 days
|
|
incidence of regrets in nightshift residents
Time Frame: 30 days
|
30 days
|
|
|
severity of regrets in nightshift residents
Time Frame: 30 days
|
Measured with the regret intensity questionnaire(RIS-10)
|
30 days
|
|
incidence of burnout symptoms in nightshift residents
Time Frame: 30 days
|
30 days
|
|
|
severity of burnout symptoms in nightshift residents
Time Frame: 30 days
|
Measured with the Copenhagen Burnout Inventory, CBI
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pauline DARBELLAY FARHOUMAND, MD, Geneva University Hospitals, General Internal Medicine Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMIG_001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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