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Quality of Life and Addiction Among Hospital Night Workers (ALADDIN)

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ClinicalTrials.gov Identifier: NCT04291534
Recruitment Status : Recruiting
First Posted : March 2, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Dr Martin Duracinsky, University Paris 7 - Denis Diderot

Study Description
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Brief Summary:

The current context of the Covid-19 health crisis leads to an over-solicitation of health systems, with hospital staff in the front line. These personnel are undergoing high levels of stress, an alteration of their life rhythm, but also of their health status and quality of life at work. In addition, night work, through the disruption of circadian rhythms, has consequences on physical and mental health. The more frequent worsening of the condition of certain patients at night increases the burden and responsibilities of night staff. Increasing the use of psychoactive substances (SPAs) can become a solution for managing stress, work rhythms, sleep disorders and their consequences. This self-medication behaviour is not without risks, neither for staff nor for patients.

The ALADDIN study is a project made up of 2 waves of questionnaires - one during and the other after the Covid "hospital" crisis - filled in by the hospital night staff of AP-HP. This project will assess the impact of the Covid-19 epidemic on the quality of work life, mental health disorders, post-traumatic stress and substance use of hospital night staff.

The main objectives of this study is to evaluate the prevalence of psychoactive substance consumption among the night shift healthcare workers of the AP-HP and to describe the participants' quality of working life.

Methods The study is prospective study using an online self-completed questionnaire. The questionnaire was elaborated on the basis of the validated scales ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test), AUDIT-C (Alcohol Use Disorder Test, shortened version) and HAD (for anxiety and depression) and on qualitative interviews conducted among care staff working the night shift.

The questionnaire will be completed at t0 (baseline) and 18 months after. This study will provide data on the consumption psychoactive substances by night hospital workers adn their quality of working life. It will also allow us to compare their consumption with the general population, and to describe the risk factors influencing the consumption.


Condition or disease
Health Services Research Quality of Life Addiction Substance-Related Disorders Health Personnel

Study Design
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Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Quality of Life and Addiction Among Hospital Night Workers - Descriptive Study of APHP Workers in Paris
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Substance use prevalence [ Time Frame: at T0 month : baseline ]
    Prevalence in APHP health workers of psychoactive substance consumption during the Covid 19 outbreak

  2. Quality of working life scale [ Time Frame: at T0 month : baseline ]
    Evaluation of the quality of working life during the Covid 19 outbreak using a validated scale


Secondary Outcome Measures :
  1. Intervention preference [ Time Frame: at T0 month ]
    Identify the preferences for intervention to improve the quality of life or change the addictive risk of night hospital staff at the APHP. Preferences for intervention methods and ranking of the least preferred.

  2. Psychoactive substance consumption and associated factors [ Time Frame: at T0 month ]

    Describe the risk factors associated with the consumption of psychoactive substances (PAS).

    Logistic or fish linear regression depending on the type of variable taken into account.


  3. Impact of substance consumption on quality of life at work [ Time Frame: at T0 month ]
    Evaluate the impact of substance use on quality of life at work Principal component analysis and classification to see if there are consumer groups for the night and / or day population. Method for taking into account missing, unused or invalid data

  4. Risk factors associated with tobacco use [ Time Frame: at T0 month ]
    Describe the risk factors associated with tobacco use among night hospital workers,

  5. Impact of sleep quality on quality of working life and perceived health [ Time Frame: at T0 month ]
    Evaluate the impact of sleep quality on the quality of working life and perceived health of night staff

  6. Impact of anxiety and depressive symptoms on sleep and QWL. [ Time Frame: at T0 month ]
    Describe the links between QWL and sleep, anxiety, depressive syndromes, and workplace upheaval.

  7. Impact of sleep and workplace upheaval on anxiety and depressives symptoms [ Time Frame: at T month ]
    Describe the links between anxiety/depressive syndromes and workplace disruption, sleep, and the Covid epidemic.

  8. Modification of quality of working life score and psychoactive substances consumption prevalences [ Time Frame: T18 months ]
    Comparison between the baseline score and prevalences and the score and prevalences 18 months after

  9. Comparison of modification of quality of life score and declared quality of life modification after 18 month [ Time Frame: T18 months ]
    Analysis of the relation between declared change and evolution of the quality of life score


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 67 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
As night workers are more prone to impaired health and to addictions, the study focuses on hospital night workers who represent a population particularly at risk.
Criteria

Inclusion Criteria:

- hospital workers at APHP, working at night or night and day alternance (working at least 3 hours between 9 p.m and 6 a.m, 2 times a week)

Exclusion Criteria:

  • Hospital workers working during the day
  • Workers working less than 3 hours a night two time a week
  • Doctors
Contacts and Locations
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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): NCT04291534


Contacts
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Contact: Lorraine COUSIN, PhDc 0683586227 cousinlorraine@gmail.comlorraine.cousin-ext@aphp.fr
Contact: Olivia Rousset Torrente, MD 0140274689 olivia.rousset-torrente-ext@aphp.fr

Locations
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France
Hôpital de Bicêtre Recruiting
Le Kremlin-Bicêtre, France, 94275
Contact: Françoise Churaqui    0145217438 ext 33    francoise.churaqui@aphp.fr   
Contact: Aïchata F Dara, MD    0140275544 ext 33    adara.proqol@gmail.com   
Assistance Publique des Hopitaux de Paris Recruiting
Paris, France, 75004
Contact: Lorraine COUSIN, PhDc    0144841777    lorraine.cousin-ext@aphp.fr   
Sponsors and Collaborators
University Paris 7 - Denis Diderot
Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Dr Martin Duracinsky, Principal Investigator, University Paris 7 - Denis Diderot
ClinicalTrials.gov Identifier: NCT04291534    
Other Study ID Numbers: ALADDIN-QoLHospWork
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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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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Substance-Related Disorders
Behavior, Addictive
Compulsive Behavior
 Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders