- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06013124
Patient/Caregiver Perceived Quality of Care
June 13, 2024 updated by: IRCCS Burlo Garofolo
Organizational Environment, Staff Well-being and Patient/Caregiver Perceived Quality of Care in a Maternal and Child Health Hospital in Italy
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Raffaella Dobrina, MSC
- Phone Number: +39 040 3785111
- Email: raffaella.dobrina@burlo.trieste.it
Study Locations
-
-
-
Trieste, Italy, 34137
- Recruiting
- IRCCS Burlo Garofolo
-
Contact:
- Raffaella Dobrina, MS
- Phone Number: +390403785
- Email: raffaella.dobrina@burlo.trieste.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Health workers, patients (adults and school-aged children), caregivers of children
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Work environment
Time Frame: Through study completion, an average of 3 year
|
Evaluated by validated questionnaire
|
Through study completion, an average of 3 year
|
|
Staff well-being
Time Frame: Through study completion, an average of 3 year
|
Evaluated by validated questionnaire
|
Through study completion, an average of 3 year
|
|
Patients/caregivers satisfaction
Time Frame: Through study completion, an average of 3 year
|
Evaluated by validated questionnaire
|
Through study completion, an average of 3 year
|
|
Patients/caregivers perceived quality of care
Time Frame: Through study completion, an average of 3 year
|
Evaluated by validated questionnaire
|
Through study completion, an average of 3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raffaella Raffaella, MSC, IRCCS Materno Infantile Burlo Garofolo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2021
Primary Completion (Estimated)
December 15, 2024
Study Completion (Estimated)
December 15, 2024
Study Registration Dates
First Submitted
March 24, 2023
First Submitted That Met QC Criteria
August 23, 2023
First Posted (Actual)
August 28, 2023
Study Record Updates
Last Update Posted (Actual)
June 14, 2024
Last Update Submitted That Met QC Criteria
June 13, 2024
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- RC 46/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Maternal and Child Health
-
Bahir Dar UniversityNot yet recruitingMaternal and Child Health | Maternal NutritionEthiopia
-
Mbarara University of Science and TechnologyMassachusetts General Hospital; University of Alabama at BirminghamCompletedMaternal Child HealthUganda
-
Gadjah Mada UniversityNot yet recruitingMaternal and Child Health
-
National University of SingaporeSaglik Bilimleri UniversitesiRecruitingMaternal and Child HealthCambodia
-
University of California, DavisUniversity of Michigan; University of California, Riverside; Lahore University...TerminatedMaternal and Child HealthPakistan
-
Healthy Child UgandaCompleted
-
Onyango SangoroUniversity College, London; Safe Water and Aids Project, Kenya; NaiLab, Kenya; Safaricom...UnknownMaternal and Child HealthKenya
-
Karnataka Health Promotion TrustUniversity of Manitoba; Bill and Melinda Gates FoundationCompleted
-
Vanderbilt UniversityCompletedMidwifery | Prenatal Care | Maternal Health Services | Perinatal Care | Maternal-child Health ServicesUnited States
-
United Arab Emirates UniversityRecruitingChild and Maternal HealthUnited Arab Emirates
Clinical Trials on Work environment, well-being, customer satisfaction
-
University of AarhusCentral Denmark RegionRecruitingStress | Well-being | Burn OutDenmark
-
IRCCS Policlinico S. DonatoRecruitingThoracic Aortic Aneurysm (TAA)Italy
-
Institut de Recherches Cliniques de MontrealCompletedType 1 Diabetes | Hypoglycemia UnawarenessCanada
-
Memorial Sloan Kettering Cancer CenterUniversity of Texas Southwestern Medical Center; Wake Forest UniversityActive, not recruitingBreast CancerUnited States