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RecruitingNCT06013124Updated Jun 14, 2024

Patient/Caregiver Perceived Quality of Care

An observational study in Maternal and Child Health, sponsored by IRCCS Burlo Garofolo. Recruiting at 1 site in Italy. Open to participants aged 6 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by IRCCS Burlo Garofolo · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
100
Ages
6 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Maternal and Child Health

Keywords

  • Patient safety
  • occupational health
  • health care quality assurance
03

Who can participate

Ages eligible
6 Years to 60 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Health workers, patients (adults and school-aged children), caregivers of children

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

Exclusion Criteria:

  • Health workers employed for less than 6 months
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherWork environment, well-being, customer satisfaction

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

05

What researchers measure

Primary outcomes

  1. Hospital Work environment

    Evaluated by validated questionnaire

    Time frame: Through study completion, an average of 3 year

  2. Staff well-being

    Evaluated by validated questionnaire

    Time frame: Through study completion, an average of 3 year

  3. Patients/caregivers satisfaction

    Evaluated by validated questionnaire

    Time frame: Through study completion, an average of 3 year

  4. Patients/caregivers perceived quality of care

    Evaluated by validated questionnaire

    Time frame: Through study completion, an average of 3 year

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06013124
Lead sponsor
IRCCS Burlo Garofolo
Responsible party
Sponsor
First posted
Aug 28, 2023
Start date
Jan 26, 2021
Primary completion
Dec 15, 2024 (estimated)
Completion
Dec 15, 2024 (estimated)
Last update
Jun 14, 2024

Study contacts

Raffaella Dobrina, MSC
Contact
raffaella.dobrina@burlo.trieste.it
+39 040 3785111
Raffaella Raffaella, MSC
principal investigator · IRCCS materno infantile Burlo Garofolo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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