Clinical Activity During Night-shift: an Ecological Study

August 31, 2020 updated by: Pauline Darbellay Farhoumand, University Hospital, Geneva
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.

Study Overview

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

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Geneva, Switzerland, 1205
        • Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

see above

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pauline DARBELLAY FARHOUMAND, MD, Geneva University Hospitals, General Internal Medicine Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2019

Primary Completion (Actual)

April 21, 2020

Study Completion (Actual)

April 21, 2020

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

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

No

Studies a U.S. FDA-regulated device product

No

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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