Maternal and Child HealthNCT06013124
Patient/Caregiver Perceived Quality of Care
An observational study of Maternal and Child Health, run by IRCCS Burlo Garofolo at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Maternal and Child Health
- What is being tested?
- Work environment, well-being, customer satisfaction
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jan 2021to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- Child, Adult
Study population: Health workers, patients (adults and school-aged children), caregivers of children
Who may be able to join
- Health workers directly involved in patients care and employed for more than 6 months
- Patients (adults, school-aged children)
- Caregivers of children
Who cannot join
- Health workers employed for less than 6 months
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Burlo Garofolo
Trieste, 34137
Raffaella Dobrina, MS, +390403785, raffaella.dobrina@burlo.trieste.it
About this study
Official title: 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.
- Conditions
- Maternal and Child Health
- Being tested
- Work environment, well-being, customer satisfaction
- Keywords
- Patient safety, occupational health, health care quality assurance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Work environment, well-being, customer satisfactionOther
Evaluation hospital work environment, staff well-being features and patients/caregivers satisfaction and perceived quality of care
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Work environment
Evaluated by validated questionnaire
Measured: Through study completion, an average of 3 year
Staff well-being
Evaluated by validated questionnaire
Measured: Through study completion, an average of 3 year
Patients/caregivers satisfaction
Evaluated by validated questionnaire
Measured: Through study completion, an average of 3 year
Patients/caregivers perceived quality of care
Evaluated by validated questionnaire
Measured: Through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start26 Jan 2021
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal and Child HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raffaella Raffaella, MSC, Principal investigator, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013124
- Sponsor's protocol ID
- RC 46/20
- Status last verified
- Aug 2023
- First submitted
- 24 Mar 2023
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organizational Environment, Staff Well-being and Patient/Caregiver Perceived Quality of Care in a Maternal and Child Health Hospital in Italy
- ClinicalTrials.gov ID
- NCT06013124
- Acronym / sponsor ID
- RC 46/20
- Conditions
- Maternal and Child Health
- Keywords
- Patient safety, occupational health, health care quality assurance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Health workers, patients (adults and school-aged children), caregivers of children
Key inclusion criteria (3 listed)
- Health workers directly involved in patients care and employed for more than 6 months
- Patients (adults, school-aged children)
- Caregivers of children
Key exclusion criteria (1 listed)
- Health workers employed for less than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Work environment, well-being, customer satisfactionEvaluation hospital work environment, staff well-being features and patients/caregivers satisfaction and perceived quality of care | Other | – |
Primary outcome
Hospital Work environment
Time frame: Through study completion, an average of 3 year
Evaluated by validated questionnaire
Staff well-being
Time frame: Through study completion, an average of 3 year
Evaluated by validated questionnaire
Patients/caregivers satisfaction
Time frame: Through study completion, an average of 3 year
Evaluated by validated questionnaire
Patients/caregivers perceived quality of care
Time frame: Through study completion, an average of 3 year
Evaluated by validated questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaella Raffaella, MSC principal investigator
IRCCS materno infantile Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal and Child Health, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raffaella Dobrina, MSC (+39 040 3785111, raffaella.dobrina@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Work environment (time frame: Through study completion, an average of 3 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.