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Clinical Activity During Night-shift: an Ecological Study

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ClinicalTrials.gov Identifier: NCT04123015
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Pauline Darbellay Farhoumand, University Hospital, Geneva

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.

Condition or disease
Nightshift Work Handoff Sessions Stress, Psychological Regret Sleep

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.


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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Clinical Activity During Night-shift: an Ecological Study
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020



Primary Outcome Measures :
  1. Incidence of nightshift interventions [ Time Frame: 12 hours ]
  2. % 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")

  3. % 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)

  4. 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"

  5. 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"

  6. Incidence of predictable nightshift emergencies [ Time Frame: 12 hours ]
    Rated on an ad-hoc scale, from "Unexpected" to "Expected"

  7. Incidence of preventable nightshift emergencies [ Time Frame: 12 hours ]
    Rated on an ad-hoc scale, from "Unpreventable" to "Very likely preventable"


Secondary Outcome Measures :
  1. incidence of sleep problems in nightshift residents [ Time Frame: 30 days ]
  2. severity of sleep problems in nightshift residents [ Time Frame: 30 days ]
    measured with the insomnia severity index questionnaire, ISI

  3. incidence of stress symptoms in nightshift residents [ Time Frame: 30 days ]
  4. 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")

  5. incidence of regrets in nightshift residents [ Time Frame: 30 days ]
  6. severity of regrets in nightshift residents [ Time Frame: 30 days ]
    Measured with the regret intensity questionnaire(RIS-10)

  7. incidence of burnout symptoms in nightshift residents [ Time Frame: 30 days ]
  8. severity of burnout symptoms in nightshift residents [ Time Frame: 30 days ]
    Measured with the Copenhagen Burnout Inventory, CBI



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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
see above
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123015


Contacts
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Contact: Pauline DARBELLAY FARHOUMAND, MD +41223729050 Pauline.Darbellay@hcuge.ch
Contact: Nicolas Garin, MD +41223729050 Nicolas.Garin@hcuge.ch

Locations
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Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland, 1205
Contact: Pauline DARBELLAY FARHOUMAND, MD    +4122372950    Pauline.Darbellay@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Pauline DARBELLAY FARHOUMAND, MD Geneva University Hospitals, General Internal Medicine Department

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Responsible Party: Pauline Darbellay Farhoumand, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04123015     History of Changes
Other Study ID Numbers: SMIG_001
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms