Clinical trial NCT06013124: Patient/Caregiver Perceived Quality of Care
Official title: Organizational Environment, Staff Well-being and Patient/Caregiver Perceived Quality of Care in a Maternal and Child Health Hospital in Italy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Maternal and Child Health
Keywords: Patient safety
occupational health
health care quality assurance
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health workers, patients (adults and school-aged children), caregivers of children

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hospital Work environment
timeFrame: Through study completion, an average of 3 year
measure: Staff well-being
timeFrame: Through study completion, an average of 3 year
measure: Patients/caregivers satisfaction
timeFrame: Through study completion, an average of 3 year
measure: Patients/caregivers perceived quality of care
timeFrame: Through study completion, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
Study officials:
affiliation: IRCCS materno infantile Burlo Garofolo
name: Raffaella Raffaella, MSC
role: PRINCIPAL_INVESTIGATOR
References: