Children With Special Health NeedsNCT05803291
Evaluation of Continuity of Care of Children With Special Health Needs
An observational study of Children With Special Health Needs, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Children and adolescents with special health care needs represent a small but relevant subset of the pediatric population due to high costs for the health care system, risk of lower quality of care, unmet health care needs, and negative health outcomes. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Children With Special Health Needs
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 26 Sep 2018to 31 Oct 2021
- 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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The study involves pediatric patients with special health care needs recruited at IRCCS Burlo Garofolo over a 12-month period and followed prospectively for the next 12 months (follow-up)
Who may be able to join
- Subjects with special health care needs requiring continuity of care and integrated home care
- Age between 0 to 17 years
- Residence in FVG region
- Outpatient, inpatient or emergency care admission at the IRCCS Burlo Garofolo hospital, Trieste, Italy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Children With Special Health Needs. Evaluation of Continuity of Care and Integrated Hospital-territory Care Pathways in Friuli Venezia Giulia
Children and adolescents with special health care needs represent a small but relevant subset of the pediatric population due to high costs for the health care system, risk of lower quality of care, unmet health care needs, and negative health outcomes. Coordination of care and continuity of care are essential issues of appropriate care for these patients, as showed also by the "Special Needs Kids" project, carried out in Emilia Romagna. This project showed the potential for family pediatricians (FP) in Italy to serve as care coordinators and facilitate the implementation of integrated care pathways for children with special health care needs. In Friuli-Venezia Giulia (FVG), a system of "continuity of care" for patients with special needs was developed and implemented. This system integrate hospital and community care in a network involving also FPs, General Practitioner and different actors of social and health services. The aim of this study is to prospectively evaluate the continuity of care provided to children and adolescents with special health needs residing in the FVG region.
- Conditions
- Children With Special Health Needs
- Keywords
- Special health needs, Continuity of care, Care coordination, Children
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess health care providers activities using the Special Needs Kids instrument
The Special Needs Kids (SpeNK)-FP instrument includes eight descriptive items aiming to collect information about the activity performed by the FP for the patients, involving the child or the family and including visit at the clinic, phone contact, ecc. In particular, SpeNK-FP evaluates: patient's clinical and social complexity on a three levels scale; requests or problems addressed; needs for care coordination; activities carried out by the FP; involvement of any other professionals in the care coordination activity; time spent for care coordination; FP's appraisal about the outcomes occurred and prevented with the care coordination activity.
Measured: Through study completion, an average of 12 months
To assess parents' perspective on continuity of care using the Special Needs Kids Questionnaire
The Special Needs Kids Questionnaire (SpeNK-Q) is a 20 items (with 5-point response option) questionnaire, evaluating parents' perspective about their relationship and interactions with: 1) the FP; 2) the main care coordinator; 3) the network of health care providers and services. SpeNK-Q includes two open questions aiming at identifying: 1) the person who is in charge of most of the child's health; (2) the person who coordinates the child's health care. The 5-point response option are: from "fully disagree" to "fully agree" for questions 1-7 concerning FP (lower scores indicates a worse outcome); form "never or almost never" to "always or almost always" for questions 8-20 concerning the network of health care providers and services.
Measured: At 10 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start26 Sep 2018
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Special Health NeedsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Zanello, MSC, Principal investigator, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803291
- Sponsor's protocol ID
- RC 17/16
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 7 Apr 2023
- 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 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children With Special Health Needs. Evaluation of Continuity of Care and Integrated Hospital-territory Care Pathways in Friuli Venezia Giulia
- ClinicalTrials.gov ID
- NCT05803291
- Acronym / sponsor ID
- RC 17/16
- Conditions
- Children With Special Health Needs
- Keywords
- Special health needs, Continuity of care, Care coordination, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 7 Apr 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.
Children and adolescents with special health care needs represent a small but relevant subset of the pediatric population due to high costs for the health care system, risk of lower quality of care, unmet health care needs, and negative health outcomes. Coordination of care and continuity of care are essential issues of appropriate care for these patients, as showed also by the "Special Needs Kids" project, carried out in Emilia Romagna. This project showed the potential for family pediatricians (FP) in Italy to serve as care coordinators and facilitate the implementation of integrated care pathways for children with special health care needs. In Friuli-Venezia Giulia (FVG), a system of "continuity of care" for patients with special needs was developed and implemented. This system integrate hospital and community care in a network involving also FPs, General Practitioner and different actors of social and health services. The aim of this study is to prospectively evaluate the continuity of care provided to children and adolescents with special health needs residing in the FVG region.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study involves pediatric patients with special health care needs recruited at IRCCS Burlo Garofolo over a 12-month period and followed prospectively for the next 12 months (follow-up)
Key inclusion criteria (4 listed)
- Subjects with special health care needs requiring continuity of care and integrated home care
- Age between 0 to 17 years
- Residence in FVG region
- Outpatient, inpatient or emergency care admission at the IRCCS Burlo Garofolo hospital, Trieste, Italy
Key exclusion criteria (1 listed)
- -
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
To assess health care providers activities using the Special Needs Kids instrument
Time frame: Through study completion, an average of 12 months
The Special Needs Kids (SpeNK)-FP instrument includes eight descriptive items aiming to collect information about the activity performed by the FP for the patients, involving the child or the family and including visit at the clinic, phone contact, ecc. In particular, SpeNK-FP evaluates: patient's clinical and social complexity on a three levels scale; requests or problems addressed; needs for care coordination; activities carried out by the FP; involvement of any other professionals in the care coordination activity; time spent for care coordination; FP's appraisal about the outcomes occurred and prevented with the care coordination activity.
To assess parents' perspective on continuity of care using the Special Needs Kids Questionnaire
Time frame: At 10 months after enrollment
The Special Needs Kids Questionnaire (SpeNK-Q) is a 20 items (with 5-point response option) questionnaire, evaluating parents' perspective about their relationship and interactions with: 1) the FP; 2) the main care coordinator; 3) the network of health care providers and services. SpeNK-Q includes two open questions aiming at identifying: 1) the person who is in charge of most of the child's health; (2) the person who coordinates the child's health care. The 5-point response option are: from "fully disagree" to "fully agree" for questions 1-7 concerning FP (lower scores indicates a worse outcome); form "never or almost never" to "always or almost always" for questions 8-20 concerning the network of health care providers and services.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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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.
Elisa Zanello, 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 Children With Special Health Needs, 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 4 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: finished, as of the sponsor's last update on 7 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess health care providers activities using the Special Needs Kids instrument (time frame: Through study completion, an average of 12 months). The study lists 2 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 7 Apr 2023.