NCT04434755

Brief Summary

Burnout, fatigue, distress and negative issues are in health care providers with different percentages. To date, little is known about the experience of burnout, fatigue and distress related with end of life and bioethical issues. The main aim of this study is to quantify burnout and identify a set of variables (meaning of life, stress, moral distress, ethical climate, resilience, positive and negative affects) that may impact on professionals dealing with end-of-life and bioethics issues in their working life. The project is an observational multicentre cross-sectional study, population-based. The target population is composed by psychologists, nurses and other healthcare providers dealing with end-of-life/palliative care and other conditions. The study will be conducted using a mixed methods, using both quantitative and qualitative approaches. Regarding the quantitative approaches, standardized questionnaires will be administered anonymously to each participant in one time only. Concerning the qualitative approaches, semi-structured interviews will be carried out until the saturation of categories is reached according to the Grounded Theory methodology It is mainly attended that this project may shed light on wellness and distress related to end-of-life and bioethical issues faced in working life by health care providers, considering not only risk factors but also protective and positive ones. The quantitative part of the research is supposed to identify the dimension of burnout in this health-care professionals category and to better clarify the role of some variables (meaning of life, stress, moral distress, ethical climate, resilience, positive and negative affects) that may modulate and affect wellness and distress experienced by this category of workers. The qualitative part of the study will help to frame better the issue, detecting the main demanding aspects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
Last Updated

July 25, 2023

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

June 8, 2020

Last Update Submit

July 24, 2023

Conditions

Keywords

burnoutdistresswellnessend of lifebioethics

Outcome Measures

Primary Outcomes (1)

  • to estimate the prevalence of the subjective perception of burnout among health-care professionals dealing with end-of-life and bioethical issues.

    Prevalence of the subjective perception of burnout among health-care professionals dealing with end-of-life and bioethcial issues

    2018-2020

Study Arms (2)

health care professionals in palliative care

health care professionals in palliative care

Other: health care professionals' exposure to bioethical issues

health care professionals in neurorehabiliation

health care professionals in neurorehabiliation

Other: health care professionals' exposure to bioethical issues

Interventions

health care professionals were differentiated considering the work context and the type of patients cured

health care professionals in neurorehabiliationhealth care professionals in palliative care

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the healthcare professionals working in unit of end-of-life/palliative care and other conditions characterized by bioethical problems in three private Institutions (IRCCS): Istituti Clinici Scientifici Maugeri Spa SB, Humanitas Research Hospital - Rozzano (Milan) and I.R.C.C.S. Santa Lucia - Centro Riabilitativo - Roma (Roma) will be eligible and invited to participate at the study.

You may qualify if:

  • psychologists, nurses and other healthcare providers dealing with end-of-life/palliative care and other conditions possibly characterized by bioethical problems.

You may not qualify if:

  • not signing the consent to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Istituto Clinico Humanitas

Milan, Italy

Location

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, Italy

Location

Fondazione Santa Lucia IRCCS

Roma, Italy

Location

Related Publications (6)

  • Hynes J, Maffoni M, Argentero P, Giorgi I, Giardini A. Palliative medicine physicians: doomed to burn? BMJ Support Palliat Care. 2019 Mar;9(1):45-46. doi: 10.1136/bmjspcare-2018-001731. No abstract available.

    PMID: 30782969BACKGROUND
  • Maffoni M, Argentero P, Giorgi I, Hynes J, Giardini A. Healthcare professionals' moral distress in adult palliative care: a systematic review. BMJ Support Palliat Care. 2019 Sep;9(3):245-254. doi: 10.1136/bmjspcare-2018-001674. Epub 2019 Jan 12.

    PMID: 30636204BACKGROUND
  • Zanatta F, Maffoni M, Giardini A. Resilience in palliative healthcare professionals: a systematic review. Support Care Cancer. 2020 Mar;28(3):971-978. doi: 10.1007/s00520-019-05194-1. Epub 2019 Dec 6.

    PMID: 31811483BACKGROUND
  • Maffoni M, Argentero P, Giorgi I, Giardini A. Healthcare professionals' perceptions about the Italian law on advance directives. Nurs Ethics. 2020 May;27(3):796-808. doi: 10.1177/0969733019878831. Epub 2019 Oct 20.

    PMID: 31631774BACKGROUND
  • Maffoni M, Argentero P, Giorgi I, Giardini A. Underneath the White Coat: Risk and Protective Factors for Palliative Care Providers in Their Daily Work. J Hosp Palliat Nurs. 2020 Apr;22(2):108-114. doi: 10.1097/NJH.0000000000000623.

    PMID: 31977533BACKGROUND
  • Maffoni M, Sommovigo V, Giardini A, Paolucci S, Setti I. Dealing with ethical issues in rehabilitation medicine: The relationship between managerial support and emotional exhaustion is mediated by moral distress and enhanced by positive affectivity and resilience. J Nurs Manag. 2020 Jul;28(5):1114-1125. doi: 10.1111/jonm.13059. Epub 2020 Jun 23.

    PMID: 32495373BACKGROUND

MeSH Terms

Conditions

Burnout, ProfessionalBurnout, PsychologicalDeath

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 17, 2020

Study Start

June 20, 2018

Primary Completion

April 26, 2019

Study Completion

April 26, 2019

Last Updated

July 25, 2023

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations