Clinical Activity During Night-shift: an Ecological Study

Sleep Clinical Trial

Official title:

Clinical Activity During Night-shift: an Ecological Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123015
• Other study ID #: SMIG_001
• Status: Completed
• Start date: October 3, 2019
• Est. completion date: April 21, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 21, 2020
• Est. primary completion date: April 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

• resident in training in the internal medicine department, involved in one or more nightshift during the study

Exclusion Criteria:

• unwilling to participate

Related Conditions & MeSH terms

• Handoff Sessions
• Nightshift Work
• Regret
• Sleep
• Stress, Psychological

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of nightshift interventions		12 hours
Primary	% of patients with nightshift interventions of different intensity	Rated on an ad-hoc scale (from "phone intervention only" to "active resuscitation")	12 hours
Primary	% 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
Primary	Incidence of selected outcomes of nightshift intervention	Rated on an ad-hoc scale (from "death" to "problem resolves without further intervention"	24 hours
Primary	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
Primary	Incidence of predictable nightshift emergencies	Rated on an ad-hoc scale, from "Unexpected" to "Expected"	12 hours
Primary	Incidence of preventable nightshift emergencies	Rated on an ad-hoc scale, from "Unpreventable" to "Very likely preventable"	12 hours
Secondary	incidence of sleep problems in nightshift residents		30 days
Secondary	severity of sleep problems in nightshift residents	measured with the insomnia severity index questionnaire, ISI	30 days
Secondary	incidence of stress symptoms in nightshift residents		30 days
Secondary	severity of stress symptoms in nightshift residents	Measured with an ad hoc scale (From "no stress at all" to "intense stress most of the time")	30 days
Secondary	incidence of regrets in nightshift residents		30 days
Secondary	severity of regrets in nightshift residents	Measured with the regret intensity questionnaire(RIS-10)	30 days
Secondary	incidence of burnout symptoms in nightshift residents		30 days
Secondary	severity of burnout symptoms in nightshift residents	Measured with the Copenhagen Burnout Inventory, CBI	30 days