NCT06013124

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 26, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

June 14, 2024

Status Verified

August 1, 2023

Enrollment Period

3.9 years

First QC Date

March 24, 2023

Last Update Submit

June 13, 2024

Conditions

Keywords

Patient safetyoccupational healthhealth care quality assurance

Outcome Measures

Primary Outcomes (4)

  • Hospital Work environment

    Evaluated by validated questionnaire

    Through study completion, an average of 3 year

  • Staff well-being

    Evaluated by validated questionnaire

    Through study completion, an average of 3 year

  • Patients/caregivers satisfaction

    Evaluated by validated questionnaire

    Through study completion, an average of 3 year

  • Patients/caregivers perceived quality of care

    Evaluated by validated questionnaire

    Through study completion, an average of 3 year

Interventions

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

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Health workers directly involved in patients care and employed for more than 6 months
  • Patients (adults, school-aged children)
  • Caregivers of children

You may not qualify if:

  • Health workers employed for less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

MeSH Terms

Interventions

Working ConditionsHealth

Intervention Hierarchy (Ancestors)

WorkplaceEmploymentSocioeconomic FactorsPopulation CharacteristicsPersonnel ManagementOrganization and AdministrationHealth Services Administration

Study Officials

  • Raffaella Raffaella, MSC

    IRCCS materno infantile Burlo Garofolo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 24, 2023

First Posted

August 28, 2023

Study Start

January 26, 2021

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

June 14, 2024

Record last verified: 2023-08

Locations