ParentsNCT05919589
Evaluating Care Integration for Children with Special Health Care Needs V1.0
An observational study of Parents and Staff Attitude, run by King's College London at 1 site in United Kingdom.
Trial summary
The Evelina London Children's Hospital (ELCH) is planning to integrate care for children with special health care needs (CSHCN) using a package of support, including 1) family support workers to manage care coordination and support parents, and 2) 'navigation' packs outlining key services, for both the services users… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parents, Staff Attitude, Healthy
- What is being tested?
- Care Integration for Children With Special Health Care Needs
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2023to 31 Mar 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents/carers of children with special health care needs (CSHCN) attending/referred to paediatric settings of Evelina London Children's Hospital (ELCH), clinical care team members from the paediatrics settings of ELCH, commissioners from Lambeth and Southwark, community health team involving CSHCN in Lambeth and Southwark, and other key stakeholders from the local NHS trust and other organisations
Who may be able to join
- Parents/care givers of CSHCN
- Staff and professional stakeholders involved (either directly or indirectly) with CSHCN
Who cannot join
- Participants under the age of 18 years
- Participants who are unable to speak and understand English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Thomas' Hospital
London, London
Ingrid Wolfe
About this study
Official title: Evaluating Care Integration for Children with Special Health Care Needs
The Evelina London Children's Hospital (ELCH) is planning to integrate care for children with special health care needs (CSHCN) using a package of support, including 1) family support workers to manage care coordination and support parents, and 2) 'navigation' packs outlining key services, for both the services users and providers.
This study aims to explore the views and experiences of key stakeholders involved with these services, including the parents/caregivers of CSHCN, and professionals/staff team members. These will be explored using semi-structured qualitative interviews.
Read the detailed description
There has been a push at the policy level to implement integrated care approaches in the USA and the UK. However, few integrated care models have been evaluated, particularly for children with special health care needs (CSHCN). This is an important group with high levels of needs, and complex and intensive use of services, and which the research team hypothesize could benefit immensely from care integration. This project aims to qualitatively evaluate care integration implementation for CSHCN, to understand how and why integrated services do (or do not) work to improve integration of care.
This research gap was confirmed by a systematic literature review on these topics, conducted by the research team (in final draft stages). The research team also facilitated workshops with local families of CSHCN and professionals to understand their experiences of care delivery, current concerns, and what should be improved.
Synthesizing information from both the systematic literature review and the workshops led to the development of this research project, which will investigate how care can be better integrated for CSHCN and their families.
The themes to be investigated will include:
- To explore the perceptions of key stakeholders on the overall quality of life, wellbeing, and community inclusion of CSHCN and their parents/caregivers. ii. To explore the perceptions of key stakeholders on CSHCN and family satisfaction with care, and care integration, including equity of access and how this is impacted by integration. iii. To explore the views of key stakeholders on the impact of the new key worker/care-coordinator service on the CSHCN and family, including school, work, family, and healthcare use.
With the learning from this project, the research team also aim to develop a model of care that can be evaluated at a larger scale in a later study and, if shown to be successful, delivered throughout the NHS and internationally.
- Conditions
- Parents, Staff Attitude, Healthy
- Being tested
- Care Integration for Children With Special Health Care Needs
- Keywords
- Children with special healthcare needs, CSHCN, Parents, Carer, Professionals, Staff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Integration for Children With Special Health Care NeedsOther
The Evelina London Children's Hospital (ELCH) is planning to integrate care for children with special health care needs (CSHCN) using a package of support, including 1) family support workers to manage care coordination and support parents, and 2) 'navigation' packs outlining key services, for both the services users and providers
| Study group | Role | What they receive |
|---|---|---|
| Parents and Carers | Parents and carers of children with special healthcare needs Receives: Other: Care Integration for Children With Special Health Care Needs | |
| Staff and professionals | Staff and professionals involved (either directly or indirectly in healthcare and other services) with children with special healthcare needs Receives: Other: Care Integration for Children With Special Health Care Needs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in perceptions of care integration for children with special healthcare needs (CSHCN) identified though qualitative interviews from baseline to follow-up
Exploring views and experiences of participants on how can care be better integrated for children with special healthcare needs (CSHCN), and their families using a 'Topic guide' through a semi-structured qualitative interview. The topic guide was developed based on present available literature on the role of a care coordinator for CSHCN and discussions with families, colleagues from paediatrics clinical team at ELCH, and the community health team for Lambeth and Southwark.
Measured: Baseline at the start of the intervention, and follow-up after at least 1 month of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Nov 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentsStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919589
- Sponsor's protocol ID
- IRAS - 317445
- Status last verified
- Mar 2024
- First submitted
- 9 Jun 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goodwin N. Understanding Integrated Care. Int J Integr Care. 2016 Oct 28;16(4):6. doi: 10.5334/ijic.2530. No abstract available.
PubMed 28316546
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Care Integration for Children with Special Health Care Needs
- ClinicalTrials.gov ID
- NCT05919589
- Acronym / sponsor ID
- IRAS - 317445
- Conditions
- Parents, Staff Attitude, Healthy
- Keywords
- Children with special healthcare needs, CSHCN, Parents, Carer, Professionals, Staff
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Jun 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.
The Evelina London Children's Hospital (ELCH) is planning to integrate care for children with special health care needs (CSHCN) using a package of support, including 1) family support workers to manage care coordination and support parents, and 2) 'navigation' packs outlining key services, for both the services users and providers.
This study aims to explore the views and experiences of key stakeholders involved with these services, including the parents/caregivers of CSHCN, and professionals/staff team members. These will be explored using semi-structured qualitative interviews.
Detailed description
There has been a push at the policy level to implement integrated care approaches in the USA and the UK. However, few integrated care models have been evaluated, particularly for children with special health care needs (CSHCN). This is an important group with high levels of needs, and complex and intensive use of services, and which the research team hypothesize could benefit immensely from care integration. This project aims to qualitatively evaluate care integration implementation for CSHCN, to understand how and why integrated services do (or do not) work to improve integration of care.
This research gap was confirmed by a systematic literature review on these topics, conducted by the research team (in final draft stages). The research team also facilitated workshops with local families of CSHCN and professionals to understand their experiences of care delivery, current concerns, and what should be improved.
Synthesizing information from both the systematic literature review and the workshops led to the development of this research project, which will investigate how care can be better integrated for CSHCN and their families.
The themes to be investigated will include:
- To explore the perceptions of key stakeholders on the overall quality of life, wellbeing, and community inclusion of CSHCN and their parents/caregivers. ii. To explore the perceptions of key stakeholders on CSHCN and family satisfaction with care, and care integration, including equity of access and how this is impacted by integration. iii. To explore the views of key stakeholders on the impact of the new key worker/care-coordinator service on the CSHCN and family, including school, work, family, and healthcare use.
With the learning from this project, the research team also aim to develop a model of care that can be evaluated at a larger scale in a later study and, if shown to be successful, delivered throughout the NHS and internationally.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents and Carers | – | Other: Care Integration for Children With Special Health Care NeedsParents and carers of children with special healthcare needs |
| Staff and professionals | – | Other: Care Integration for Children With Special Health Care NeedsStaff and professionals involved (either directly or indirectly in healthcare and other services) with children with special healthcare needs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents/carers of children with special health care needs (CSHCN) attending/referred to paediatric settings of Evelina London Children's Hospital (ELCH), clinical care team members from the paediatrics settings of ELCH, commissioners from Lambeth and Southwark, community health team involving CSHCN in Lambeth and Southwark, and other key stakeholders from the local NHS trust and other organisations
Key inclusion criteria (2 listed)
- Parents/care givers of CSHCN
- Staff and professional stakeholders involved (either directly or indirectly) with CSHCN
Key exclusion criteria (2 listed)
- Participants under the age of 18 years
- Participants who are unable to speak and understand English
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 |
|---|---|---|
| Care Integration for Children With Special Health Care NeedsThe Evelina London Children's Hospital (ELCH) is planning to integrate care for children with special health care needs (CSHCN) using a package of support, including 1) family support workers to manage care coordination and support parents, and 2) 'navigation' packs outlining key services, for both the services users and providers | Other | Parents and Carers, Staff and professionals |
Primary outcome
Changes in perceptions of care integration for children with special healthcare needs (CSHCN) identified though qualitative interviews from baseline to follow-up
Time frame: Baseline at the start of the intervention, and follow-up after at least 1 month of the intervention.
Exploring views and experiences of participants on how can care be better integrated for children with special healthcare needs (CSHCN), and their families using a 'Topic guide' through a semi-structured qualitative interview. The topic guide was developed based on present available literature on the role of a care coordinator for CSHCN and discussions with families, colleagues from paediatrics clinical team at ELCH, and the community health team for Lambeth and Southwark.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 28316546Goodwin N. Understanding Integrated Care. Int J Integr Care. 2016 Oct 28;16(4):6. doi: 10.5334/ijic.2530. No abstract available.
- Integrated Care: Our Shared Commitment. A framework that outlines ways to improve health and social care integration. From: Department of Health \& Social CareLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
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 Parents and Staff Attitude, run by King's College London at 1 site in United Kingdom.
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 2 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 17 Mar 2025. 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 United Kingdom. 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 Ingrid Wolfe, PhD (+447740148900, ingrid.wolfe@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in perceptions of care integration for children with special healthcare needs (CSHCN) identified though qualitative interviews from baseline to follow-up (time frame: Baseline at the start of the intervention, and follow-up after at least 1 month of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05919589, which also lists 1 linked publication.
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 17 Mar 2025.