Pediatric Hospital CareCHOICENCT06007287
WHO Standards for Improving the Quality of Child Hospital Care
An observational study of Pediatric Hospital Care, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Even in high-income countries, quality of pediatric health care has been described as substandard in many settings, resulting in worst health outcomes and increased cost for the health system. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pediatric Hospital Care
- How many people
- 880 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2019to 1 Mar 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Service users (ie, parents of children hospitalized and their children) and service providers (ie, clinical staff working providing care to children).
Who may be able to join
- Service Users: parents/ other caretakers of children hospitalised in the Pediatric ward (ordinary hospitalization) and the pediatric emergency unit (brief intensive observation) between 0-15 years in all participating hospital
- Service Providers: all healthcare providers routinely assisting children in the participating units of the hospitals, namely: doctors, doctors in training, nurses
Who cannot join
- Service Users
- Parents/ caretakers with age < 18 years
- Parents/caretakers of a child > 15 years of age (WHO standards cover up to 15 years)
- Parents/ caretakers of deceased child or of a child admitted to intensive care at the time of administration of the questionnaire
- Parents/caretakers with concomitant serious psychiatric disorders
- Parents/caretakers of a child hospitalized at Child Neuropsychiatry or Surgery Department
Show all 14Show fewer
- Parents/caretakers of a child hospitalized as a Day Hospital
- Parents/caretakers in surgery department/beds of neuro/psychiatric department/beds
- Parents//caretakers with primarily surgery serious psychiatric disorders
- Refusal to participate.
- Service Providers
- Personnel not routinely involved in the overall clinical care
- Prolonged absence from work (eg maternity leave) and/or unavailability during the study period
- Personnel working only on surgical conditions or neuro/psychiatric, or other special
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Burlo Garofolo
Trieste, 34137
Marzia Lazzerini, MD, +390403785555, marzia.lazzerini@burlo.trieste.it
About this study
Official title: Implementation of World Health Organization Standards for Improving the Quality of Pediatric Hospital Care
Even in high-income countries, quality of pediatric health care has been described as substandard in many settings, resulting in worst health outcomes and increased cost for the health system. Nevertheless, still there is a paucity of studies documenting the quality of care for children in a comprehensive and systematic manner, using international standards, and validated data collection tools. The World Health Organization (WHO) developed three sets standards for improving the quality of maternal newborn and child health care. The aim of this study is to test the use of the WHO Pediatric standards for improving the quality of child hospital care, as summarized by a score of total mean quality score for patients (range 0-100 points).
Read the detailed description
Achieving the Sustainable Development Goal (SDG) goal 3 targets as elaborated in the WHO Global Strategy for Women's, Children's, and Adolescent's Health (2016-2030) will require ensuring universal access to safe, effective, quality and affordable care for women, children and adolescents. Despite the progress made in the last two decades, an estimated 6.6 million infants, children and young adults still died in 2016 (5.6 million children under five and 1 million children aged 5-14) mostly from preventable causes. To provide universal health coverage with quality, every woman, child and adolescent should receive quality care throughout their life course and during care. This requires institutionalization of safe, effective, quality service delivery.
Studies have shown that most often children do not receive basic elements of care or are often inappropriately managed, and their rights as patients are not respected. Therefore, urgent actions are required to ensure that the care given to all children in health facilities is evidence-based, safe, effective, timely, efficient, equitable and appropriate for their age and stage of development, and that care provided is child and family centred, and that all rights of children are respected. WHO recently launched (May 2018) the "Standards for improving quality of care for children and young adolescents in health facilities", to address the quality of care for children 0-15 years of age in health facilities. These pediatric Standards complement previous standards addressing quality of maternal and newborn care.
The WHO standards are based on a WHO paediatric quality of care framework, which highlights 8 specific domains of care that are critical to providing quality care for children (Fig. 1). These domains are organized into three main categories: provision of care (including: 1. Evidenced based practices; 2. Actionable information system; 3. Functioning referral system), experience of care (including: 4. Effective communication; 5. Respect, protection and fulfilment of child rights; 6. Emotional and psychological support) and availability of child- and adolescent-friendly resources (including 7. Competent, motivated, empathetic human resources and 8. Essential child and adolescent-friendly physical resources). The framework takes into account children's right to health and recognizes that their needs are different from those of adults.
Currently there is very limited field experience in the use of the WHO Standards for improving Quality of Care. More in general, routine use of data to improve case management and organization of care is still not a common practice, even in countries with well-established data collection systems. Despite there are some good examples of how routine data collection systems are used to shape health policies and strategies in the pediatric field in low and middle-income countries, these are quite limited in number, with most of the experience being conducted in a research/project setting.
he aim of this study is to test the use of the WHO Pediatric standards for improving the quality of child hospital care, as summarized by a score of total mean quality score for patients (range 0-100 points).
- Conditions
- Pediatric Hospital Care
- Keywords
- Quality of Care, WHO standards, Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Maternal and Newborn Care Index
Evaluation of total mean quality score for patients (range 0-100 points)
Measured: At hospital discharge (assessed up to day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start7 Jan 2019
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Hospital CareStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marzia Lazzerini, MD, Study chair, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007287
- Sponsor's protocol ID
- RC 15/19
- Acronym
- CHOICE
- Status last verified
- Aug 2023
- First submitted
- 28 Mar 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of World Health Organization Standards for Improving the Quality of Pediatric Hospital Care
- ClinicalTrials.gov ID
- NCT06007287
- Acronym / sponsor ID
- CHOICE / RC 15/19
- Conditions
- Pediatric Hospital Care
- Keywords
- Quality of Care, WHO standards, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 23 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.
Even in high-income countries, quality of pediatric health care has been described as substandard in many settings, resulting in worst health outcomes and increased cost for the health system. Nevertheless, still there is a paucity of studies documenting the quality of care for children in a comprehensive and systematic manner, using international standards, and validated data collection tools. The World Health Organization (WHO) developed three sets standards for improving the quality of maternal newborn and child health care. The aim of this study is to test the use of the WHO Pediatric standards for improving the quality of child hospital care, as summarized by a score of total mean quality score for patients (range 0-100 points).
Detailed description
Achieving the Sustainable Development Goal (SDG) goal 3 targets as elaborated in the WHO Global Strategy for Women's, Children's, and Adolescent's Health (2016-2030) will require ensuring universal access to safe, effective, quality and affordable care for women, children and adolescents. Despite the progress made in the last two decades, an estimated 6.6 million infants, children and young adults still died in 2016 (5.6 million children under five and 1 million children aged 5-14) mostly from preventable causes. To provide universal health coverage with quality, every woman, child and adolescent should receive quality care throughout their life course and during care. This requires institutionalization of safe, effective, quality service delivery.
Studies have shown that most often children do not receive basic elements of care or are often inappropriately managed, and their rights as patients are not respected. Therefore, urgent actions are required to ensure that the care given to all children in health facilities is evidence-based, safe, effective, timely, efficient, equitable and appropriate for their age and stage of development, and that care provided is child and family centred, and that all rights of children are respected. WHO recently launched (May 2018) the "Standards for improving quality of care for children and young adolescents in health facilities", to address the quality of care for children 0-15 years of age in health facilities. These pediatric Standards complement previous standards addressing quality of maternal and newborn care.
The WHO standards are based on a WHO paediatric quality of care framework, which highlights 8 specific domains of care that are critical to providing quality care for children (Fig. 1). These domains are organized into three main categories: provision of care (including: 1. Evidenced based practices; 2. Actionable information system; 3. Functioning referral system), experience of care (including: 4. Effective communication; 5. Respect, protection and fulfilment of child rights; 6. Emotional and psychological support) and availability of child- and adolescent-friendly resources (including 7. Competent, motivated, empathetic human resources and 8. Essential child and adolescent-friendly physical resources). The framework takes into account children's right to health and recognizes that their needs are different from those of adults.
Currently there is very limited field experience in the use of the WHO Standards for improving Quality of Care. More in general, routine use of data to improve case management and organization of care is still not a common practice, even in countries with well-established data collection systems. Despite there are some good examples of how routine data collection systems are used to shape health policies and strategies in the pediatric field in low and middle-income countries, these are quite limited in number, with most of the experience being conducted in a research/project setting.
he aim of this study is to test the use of the WHO Pediatric standards for improving the quality of child hospital care, as summarized by a score of total mean quality score for patients (range 0-100 points).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Service users (ie, parents of children hospitalized and their children) and service providers (ie, clinical staff working providing care to children).
Key inclusion criteria (2 listed)
- Service Users: parents/ other caretakers of children hospitalised in the Pediatric ward (ordinary hospitalization) and the pediatric emergency unit (brief intensive observation) between 0-15 years in all participating hospital
- Service Providers: all healthcare providers routinely assisting children in the participating units of the hospitals, namely: doctors, doctors in training, nurses
Key exclusion criteria (14 listed)
- Service Users
- Parents/ caretakers with age < 18 years
- Parents/caretakers of a child > 15 years of age (WHO standards cover up to 15 years)
- Parents/ caretakers of deceased child or of a child admitted to intensive care at the time of administration of the questionnaire
- Parents/caretakers with concomitant serious psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Maternal and Newborn Care Index
Time frame: At hospital discharge (assessed up to day 5)
Evaluation of total mean quality score for patients (range 0-100 points)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
Marzia Lazzerini, MD study chair
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 Pediatric Hospital Care, 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 2 inclusion and 14 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 26 Mar 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 Marzia Lazzerini, MD (+390403785555, marzia.lazzerini@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Maternal and Newborn Care Index (time frame: At hospital discharge (assessed up to day 5)). 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 26 Mar 2024.