Clinical Activity During Night-shift: an Ecological Study
1 other identifier
observational
41
1 country
1
Brief Summary
A convenient sample of internal medicine residents will be observed during their nightshift work in the wards of the department of internal medicine of a university hospital. The epidemiology of night calls and emergencies, including incidence, causes, management, and prognosis, will be assessed prospectively. The impact of nightshift work on sleep, stress, quality of life, regrets, and general well being of the residents observed will be measured through completion of validated questionnaires. Quality of handoff sessions will also be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2019
CompletedStudy Start
First participant enrolled
October 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2020
CompletedSeptember 2, 2020
August 1, 2020
7 months
October 3, 2019
August 31, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
Incidence of nightshift interventions
12 hours
% of patients with nightshift interventions of different intensity
Rated on an ad-hoc scale (from "phone intervention only" to "active resuscitation")
12 hours
% of patients with different causes of nightshift interventions
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
Rated on an ad-hoc scale (from "death" to "problem resolves without further intervention"
24 hours
Incidence of specific interventions during nightshift
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
Rated on an ad-hoc scale, from "Unexpected" to "Expected"
12 hours
Incidence of preventable nightshift emergencies
Rated on an ad-hoc scale, from "Unpreventable" to "Very likely preventable"
12 hours
Secondary Outcomes (8)
incidence of sleep problems in nightshift residents
30 days
severity of sleep problems in nightshift residents
30 days
incidence of stress symptoms in nightshift residents
30 days
severity of stress symptoms in nightshift residents
30 days
incidence of regrets in nightshift residents
30 days
- +3 more secondary outcomes
Eligibility Criteria
see above
You may qualify if:
- resident in training in the internal medicine department, involved in one or more nightshift during the study
You may not qualify if:
- unwilling to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Geneva University Hospitals
Geneva, 1205, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pauline DARBELLAY FARHOUMAND, MD
Geneva University Hospitals, General Internal Medicine Department
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 10, 2019
Study Start
October 3, 2019
Primary Completion
April 21, 2020
Study Completion
April 21, 2020
Last Updated
September 2, 2020
Record last verified: 2020-08