- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07450339
Compassion Fatigue in Healthcare Workers Working in the Emergency Department, Emergency Room, and General Intensive Care Units. (EMERGENCY)
Compassion Fatigue in Healthcare Workers Working in the Emergency Department, Emergency Room, and General Intensive Care Units. A PRE-POST Participatory Action Research Study
Compassion Fatigue can be conceptualized as consisting of two components (Gentry, 2015): (1) burnout, and (2) secondary traumatic stress (STS), also referred to as vicarious trauma.
The study includes a quantitative assessment through the administration of the Professional Quality of Life Scale (Professional Quality of Life: Compassion Satisfaction and Fatigue, Version 5; Stamm, 2009) at two time points, baseline (T0) and follow-up (T1), to measure levels of Compassion Fatigue among healthcare professionals working within the Emergency Department, specifically in the Emergency Room and General Intensive Care Unit.
In the interval between the two quantitative assessments, following T0 and preceding T1, a Participatory Action Research (PAR) approach will be conducted. The study will also explore potential protective and risk factors related to Compassion Fatigue specific to the Emergency Room and General Intensive Care Unit settings. The Participatory Action Research will be carried out using focus group methodology.
The primary objective of the study is to assess Compassion Fatigue (Larsen & Stamm, 2008) among healthcare professionals working in the Emergency Department, specifically in the Emergency Room and General Intensive Care Unit of the Fondazione IRCCS Policlinico San Matteo in Pavia, before (T0) and after (T1) the implementation of the Participatory Action Research conducted through focus groups. The second assessment (T1) will be carried out 18 months after the baseline assessment (T0)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lombardy
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Pavia, Lombardy, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Minimum age of 18 years at the time of questionnaire completion;
- Employment in the Emergency Room or General Intensive Care Unit of the Fondazione IRCCS Policlinico San Matteo as a physician, nurse, or healthcare assistant at the time of questionnaire completion;
- Provision of written informed consent. Exclusion Criteria
- Individuals who, although employed at the Policlinico San Matteo at the time of questionnaire completion, do not work as physicians, nurses, or healthcare assistants or do not reside in Italy at the time of questionnaire completion;
- Individuals who, although employed at the Policlinico San Matteo at the time of questionnaire completion and working as physicians, nurses, or healthcare assistants, are not assigned to one of the departments involved in the study (Emergency Room or General Intensive Care Unit).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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16groups composed of different healthcare professionals from the Emergency Department and ICU
Participants were stratified according to clinical department (Emergency Department and Intensive Care Unit) and professional role (physician, medical residents, nurses, and healthcare assistants), resulting in a total of 16 groups.
Each group was invited to participate in a series of focus groups aimed at exploring topics such as burnout, secondary traumatic stress, coping strategies, and related psychological experiences.
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The focus groups were organized into five modules: (1) compassion fatigue, burnout, and secondary traumatic stress; (2) coping strategies (problem-focused and emotion-focused coping); (3) work motivation and work-related stress; (4) work-life balance; and (5) advice and work organization
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The primary endpoint will be the change in the Professional Quality of Life: Compassion Satisfaction and Fatigue, Version 5 (Stamm, 2009) score measured before (T0) and after (T1) the focus group sessions.
Time Frame: from enrollment to the end of treatment at 18 months
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The primary objective will be measured using the following psychological instrument: the Professional Quality of Life: Compassion Satisfaction and Fatigue, Version 5 (ProQOL; Stamm, 2009), a self-report questionnaire consisting of 20 items designed to assess Compassion Fatigue in caregiving activities. The primary endpoint will be the difference between the Professional Quality of Life scores measured at the 18-month follow-up (T1) after the Participatory Action Research (focus groups) and the baseline assessment (T0), both overall and stratified by clinical department. |
from enrollment to the end of treatment at 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in score on the professional burnout subscale
Time Frame: from the enrollment to the end of treatment at 18 months
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The Student's t-test (or its non-parametric equivalent, the Wilcoxon signed-rank test) will be used for paired data to compare the score on the professional burnout scale recorded at T1 with that recorded at T0.
The analyses will be repeated for each UOC.
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from the enrollment to the end of treatment at 18 months
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Change in the Secondary Traumatic Stress sub scale score
Time Frame: from the enrollment to the end of treatment at 18 months
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Change in the Secondary Traumatic Stress sub scale score: The higher the score, the higher the level of secondary traumatization. |
from the enrollment to the end of treatment at 18 months
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Association between participants' characteristics and level of participation with changes in scale scores
Time Frame: From the enrollment to the end of treatment at 18 months
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Association between participants' characteristics and level of participation with changes in scale scores
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From the enrollment to the end of treatment at 18 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Occupational Stress
- Behavioral Symptoms
- Stress, Psychological
- Fatigue
- Mental Fatigue
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Burnout, Psychological
- Compassion Fatigue
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Focus Groups
Other Study ID Numbers
- EMERGENCY FATIGUE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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