START: Evaluation of the Satisfaction and Relevance of Leadership Training for Residents

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05561283
Collaborator
(none)
24
1
1
17
1.4

Study Details

Study Description

Brief Summary

Health students are the future actors of the health system. They are exposed to many stressors in their journey. The quality of life of medical students is alarming worldwide: 11.1% of undergraduate and postgraduate residents reportedly have suicidal ideation and 27.2% have depressive symptoms. In addition, 44.2% suffer from burn-out syndrome. In the third cycle, 28.8% suffer from depressive symptoms and 35.1% from burn-out syndrome. This finding is shared internationally among medical residents. Health professionals are facing a global problem which it is crucial to act.

At national level, a survey on the mental health of young doctors carried out in 2017 found, among the 7603 residents who responded a prevalence: 22.8% of depressive symptoms, 59.7% of anxiety symptoms, 23.4% of suicidal thoughts, including 5.0% in the month prior to the survey. In 2018, a French report on the quality of life of health by Dr Donata Marra highlighted a real malaise affecting residents and the need to intervene "for residents, for carers and for patients", through the implementation of specific recommendations. The proposal 6 of the report emphasises the prevention of psychosocial risks through educational interventions such as training in collaborative management. On a personal level, the aim is to the leadership of each individual, in terms of stress management, communication, cross-disciplinary skills or even the introduction of relational simulations in the teaching of an awareness of deviant behaviour and harassment. The stress factors are indeed multiple during health studies confrontation with death, competition, increasing responsibilities… Perceived stress has a negative impact on the quality of life and burnout. Effective stress management strategies could therefore help to improve the quality of life of residents.

In this context, the analysis of the literature highlights three main areas of intervention that could contribute to resident leadership in favour of their quality of life: stress management, healthy living and the construction of a professional identity.

The Junior Leadership programme for residents from the beginning of their professional formation designed to provide basic knowledge and skills in healthcare leadership and to develop cross-disciplinary skills. The aim is to provide the necessary support for the success of the resident's professional project by participating in the improvement of their quality of life and the prevention of psycho-social risks.

The study therefore propose to evaluate the feasibility of training in leadership and meditation on the satisfaction of resident.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Self-questionnaires
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of the Satisfaction and Relevance of Leadership Training for Residents - START Study
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort of residents

Medical residents undergoing the leadership and meditation training

Diagnostic Test: Self-questionnaires
Self-questionnaires on satisfaction, burn-out, depression, anxiety, relational skills and sleep quality

Outcome Measures

Primary Outcome Measures

  1. Description of the satisfaction on the Junior Leadership programme for residents evaluated by the questionnaire recommanded by the HAS [At 4 months (at the end of the training that lasts around 4 months)]

    The satisfaction of the residents will be evaluated by a self-questionnaire according to model recommended by the Haute Autorité de Santé (HAS)and used in the framework of the SAMSEI programme (SAMSEI="Stratégies d'Apprentissage des Métiers de Santé en Environnement Immersif" that means in English "Learning Strategies for Healthcare Professions in an Immersive Environment") and the Lyon South Health Simulation Centre. The questionnaire will evaluate the interest, practical usefulness, density of information information, conformity with the objectives, the material conditions of the training, the activity of the participants and the motivation to continue the training.

Secondary Outcome Measures

  1. Change of proportion of burn-out evaluated the Maslach's burn-out inventory scale [Before training (baseline) and 3 months, 6 months and 1 year after training]

    The proportion of residents showing symptoms of burn-out will be assessed by the Maslach's burn-out inventory before training and 3 months, 6 months and 1 year after training.

  2. Change int he presence of symptoms of anxiety and depression evaluated by the HADS scale [Before training (baseline) and 3 months, 6 months and 1 year after training]

    Anxiety and depression symptoms will be assessed by Hospital Anxiety and Depression Scale (HADS) before training and at 3 months, 6 months and 1 year after training.

  3. Change of the real-life stress levels in the professional environment of residents evaluated by the Karasek scale [Before training (baseline) and 3 months, 6 months and 1 year after training]

    The stress of residents in their work environment will be assessed using the Karasek scale, which evaluates psychosocial risk factors at work before training and at 3 months, 6 months and and 1 year after the training

  4. Change of relational skills evaluated by Cungi and Rey's communication scale [Before training (baseline) and 3 months, 6 months and 1 year after training]

    Caregivers' interpersonal skills will be assessed by Cungi and Rey's communication scale at 3 months, 6 months and 1 year after the training.

  5. Change of sleep quality of the residents evaluated by the LEEDS scale [Before training (baseline) and 3 months, 6 months and 1 year after training]

    The sleep quality of the residents will be assessed by the LEEDS scale before training and at 3 months, 6 months and 1 year after training

  6. Change of the use of psychoactive substances by residents collected by questionnaire [Before training (baseline) and 3 months, 6 months and 1 year after training]

    The use of psychoactive substances will be collected from residents before the training and at 3 months, 6 months and 1 year after the training

  7. Change of the use of medical/psychological by residents collected by questionnaire [Before training (baseline) and 3 months, 6 months and 1 year after training]

    The use of medical/psychological support will be collected from residents before the training and at 3 months, 6 months and 1 year after the training.

  8. Change of the number of days off for sikness collected by questionnaire [Before training (baseline) and 3 months, 6 months and 1 year after training]

    The number of days off sick will be collected from the residents before the training and at 3 months, 6 months and 1 year after the training.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • residents assigned to the Hospices Civils de Lyon

  • Informed consent given by the resident

Exclusion Criteria:
  • Pregnant women, women in labour or nursing mothers

  • Persons deprived of their liberty by a judicial or administrative decision

  • Persons under psychiatric care

  • Persons of full age who are subject to a legal protection measure (guardianship, curatorship)

  • Persons who are not affiliated to a social security scheme or who are beneficiaries of a similar scheme

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pôle de simulation en Santé de Lyon Sud (PL3S) Oullins France 69921

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05561283
Other Study ID Numbers:
  • 69HCL21_1273
First Posted:
Sep 30, 2022
Last Update Posted:
Sep 30, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon

Study Results

No Results Posted as of Sep 30, 2022