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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06013124
Other study ID # RC 46/20
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 26, 2021
Est. completion date December 15, 2024

Study information

Verified date August 2023
Source IRCCS Burlo Garofolo
Contact Raffaella Dobrina, MSC
Phone +39 040 3785111
Email raffaella.dobrina@burlo.trieste.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hospitals quality, safety, and staff workload problems are common in all countries. Findings from the multicountry Nurse forecasting in Europe (RN4CAST) cross sectional study show that patient risk of mortality within a 30 days of hospital stay increases of 7% when a patient is added to the nurse-patient 1:6 proportion in a surgical unit; in Italy, the ratio was found to be 9.5 patients per nurse. Organizational environment, health workers wellbeing and work satisfaction were also found to impact patient safety and perceived patient satisfaction; hospitals nurses high workload, work dissatisfaction and burnout were found related to poor patients outcomes. In a systematic review and meta-analysis, an association of more than 60% between physicians and nurses development of burnout and patient safety in pediatric settings was found; when health workers wellness and teamwork in wards was poor lower perceptions of safety culture was found. Moreover, occupational exposure to medically complex children and their families along with direct care providers unexpressed grief further increase pediatric settings staff risk of developing burnout syndrome and compassion fatigue. Recent findings of Covid-19 pandemic negative impact on health workers well-being worldwide also enhances the risk of compromising the quality of care provided. The aim of this study is to evaluate factors that affect health workers well-being, their perception of work environment and patient/caregiver satisfaction and perceived quality of care in a maternal and child health hospital.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 15, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers
Gender All
Age group 6 Years to 60 Years
Eligibility Inclusion Criteria: - Health workers directly involved in patients care and employed for more than 6 months - Patients (adults, school-aged children) - Caregivers of children Exclusion Criteria: - Health workers employed for less than 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Work environment, well-being, customer satisfaction
Evaluation hospital work environment, staff well-being features and patients/caregivers satisfaction and perceived quality of care

Locations

Country Name City State
Italy IRCCS Burlo Garofolo Trieste

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Work environment Evaluated by validated questionnaire Through study completion, an average of 3 year
Primary Staff well-being Evaluated by validated questionnaire Through study completion, an average of 3 year
Primary Patients/caregivers satisfaction Evaluated by validated questionnaire Through study completion, an average of 3 year
Primary Patients/caregivers perceived quality of care Evaluated by validated questionnaire Through study completion, an average of 3 year
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