Clinical trial NCT04123015: Clinical Activity During Night-shift: an Ecological Study
Official title: Clinical Activity During Night-shift: an Ecological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nightshift Work
Handoff Sessions
Stress, Psychological
Regret
Sleep
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 41
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: see above

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* unwilling to participate

Primary outcomes:
measure: Incidence of nightshift interventions
timeFrame: 12 hours
measure: % of patients with nightshift interventions of different intensity
timeFrame: 12 hours
measure: % of patients with different causes of nightshift interventions
timeFrame: 12 hours
measure: Incidence of selected outcomes of nightshift intervention
timeFrame: 24 hours
measure: Incidence of specific interventions during nightshift
timeFrame: 12 hours
measure: Incidence of predictable nightshift emergencies
timeFrame: 12 hours
measure: Incidence of preventable nightshift emergencies
timeFrame: 12 hours
Secondary outcomes:
measure: incidence of sleep problems in nightshift residents
timeFrame: 30 days
measure: severity of sleep problems in nightshift residents
timeFrame: 30 days
measure: incidence of stress symptoms in nightshift residents
timeFrame: 30 days
measure: severity of stress symptoms in nightshift residents
timeFrame: 30 days
measure: incidence of regrets in nightshift residents
timeFrame: 30 days
measure: severity of regrets in nightshift residents
timeFrame: 30 days
measure: incidence of burnout symptoms in nightshift residents
timeFrame: 30 days
measure: severity of burnout symptoms in nightshift residents
timeFrame: 30 days
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: Geneva University Hospitals, General Internal Medicine Department
name: Pauline DARBELLAY FARHOUMAND, MD
role: PRINCIPAL_INVESTIGATOR
References: