Children With Complex Care NeedsSPARKLeNCT07801911
Feasibility of the Implementation of the SPARKLe Nurse-led Integrated Transitional Care Model for Children With Complex Care Needs
A study testing SPARKLe model in people with Children With Complex Care Needs and Chronic Conditions, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
Children with complex care needs often experience fragmented care during transitions from hospital to home, leading to unmet needs and increased burden on families. The SPARKLe project aims to address this gap through a nurse-led integrated transitional care model. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Children With Complex Care Needs, Chronic Conditions, Care Coordination
- What is being tested?
- SPARKLe model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- 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 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 0 to 16 years with complex care needs
- Admitted to a general pediatric unit at the University Children's Hospital Zurich for more than 24 hours
- Families of eligible children willing to participate in study procedures
- Hospital healthcare professionals involved in the care of included children
- Community healthcare providers involved in post-discharge care of included children
Who cannot join
- Children receiving care within an already established specialized care program at the hospital (e.g., palliative care or oncology care programs) Families declining participation Hospital professionals not directly involved in the care of included children Community providers not involved in the child's post-discharge care
Trial locations and contacts
1 site in 1 country.
About this study
Children with complex care needs often experience fragmented care during transitions from hospital to home, leading to unmet needs and increased burden on families. The SPARKLe project aims to address this gap through a nurse-led integrated transitional care model. This study evaluates the feasibility of implementing the SPARKLe model in a real-world hospital setting using a mixed-methods design, focusing on implementation outcomes including feasibility, acceptability, adoption, and fidelity.
Read the detailed description
Children with complex care needs (CCN) often require coordinated care across multiple healthcare providers and settings. Transitions from hospital to home represent particularly vulnerable periods and are frequently characterized by fragmented care, communication gaps, and unclear responsibilities. These challenges can result in unmet needs, duplication of services, increased burden on families, and preventable hospital readmissions.
To address these challenges, the SPARKLe project developed a nurse-led integrated transitional care model designed to improve coordination and continuity of care for children with complex care needs. The model was informed by contextual analysis and stakeholder engagement and is aligned with international frameworks on integrated care as well as national healthcare strategies in Switzerland.
This study evaluates the feasibility of implementing the SPARKLe model in a real-world hospital setting at the University Children's Hospital Zurich. The model includes key components such as early identification of eligible patients, structured needs assessment, active family engagement, standardized information transfer, and follow-up care coordination across settings.
A mixed-methods design was used to assess implementation outcomes, including feasibility, acceptability, adoption, and fidelity. Quantitative data were collected through medical chart reviews, while qualitative data were obtained through interviews with families, focus groups with healthcare professionals, and surveys among community care providers.
The study aims to generate insights into the implementation process, identify barriers and facilitators, and inform further refinement and potential scale-up of the SPARKLe model.
- Conditions
- Children With Complex Care Needs, Chronic Conditions, Care Coordination, Transitional Care
- Being tested
- SPARKLe model
- Keywords
- SPARKLe, Children with complex care needs, Integrated Care, Tranisitional Care, Implementation, Care Coordination, Feasibility Study
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARKLe modelBehavioural
The SPARKLe model is a nurse-led integrated transitional care intervention for children with complex care needs. It includes key components such as early identification of eligible patients, structured needs assessment, active family engagement, standardized information transfer, and coordination of follow-up care across healthcare settings.
| Study group | Role | What they receive |
|---|---|---|
| SPARKLe intervention | Experimental | Participants receive the SPARKLe nurse-led integrated transitional care model designed to improve coordination and continuity of care for children with complex care needs during the transition from hospital to home. Receives: Behavioral: SPARKLe model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the SPARKLe care model among community providers
Feasibility of the SPARKLe care model from the perspective of community providers was assessed using four survey items adapted from the Feasibility of Intervention Measure (FIM), together with selected items informed by the Normalization Measure Development (NoMAD) instrument. NoMAD-informed items assessed coherence, cognitive participation, and collective action related to implementation and integration of the SPARKLe care model into routine practice. Survey items were rated on a five-point Likert scale ranging from strongly disagree to strongly agree.
Measured: Approximately 2-3 weeks after hospital discharge.
Secondary outcomes (6)
Qualitative perceptions of feasibility of the SPARKLe care model
Feasibility was explored among family caregivers and hospital health professionals through semi-structured individual interviews and interprofessional focus group interviews. Questions examined the practicality of implementing individual SPARKLe care model components, including identification of children with complex care needs, needs assessment and transition planning, family engagement, communication with community providers, and post-discharge follow-up. Qualitative data were analyzed using rapid qualitative analysis and summarized as themes related to perceived feasibility.
Measured: During the 4-month feasibility evaluation period, with family caregiver interviews conducted approximately 2 weeks after hospital discharge.
Acceptability of the SPARKLe care model among community providers
Acceptability of the SPARKLe care model from the perspective of community providers was assessed using four survey items adapted from the Acceptability of Intervention Measure (AIM). Survey items were rated on a five-point Likert scale ranging from strongly disagree to strongly agree.
Measured: Approximately 2-3 weeks after hospital discharge
Qualitative perceptions of acceptability of the SPARKLe care model
Acceptability was explored among family caregivers and hospital health professionals through semi-structured individual interviews and interprofessional focus group interviews. Questions examined satisfaction with and perceptions of the usefulness, appropriateness, and overall experience of the SPARKLe care model. Qualitative data were analyzed using rapid qualitative analysis and summarized as themes related to perceived acceptability.
Measured: During the 4-month feasibility evaluation period, with family caregiver interviews conducted approximately 2 weeks after hospital discharge.
Early adoption of the SPARKLe care model assessed through healthcare professional focus group interviews
Early adoption was explored among hospital health professionals through semi-structured interprofessional focus group interviews. Questions adapted from the Evidence-Based Practice Attitude Scale (EBPAS) examined initial uptake, engagement with the intervention, willingness to use the SPARKLe care model, perceived value of the intervention, and intentions to continue SPARKLe-related care coordination activities in routine practice. Qualitative data were analyzed using rapid qualitative analysis and summarized as themes related to early adoption.
Measured: During the 4-month implementation period
Proportion of SPARKLe intervention components implemented as intended
Implementation fidelity was assessed using a structured fidelity assessment evaluating whether individual SPARKLe intervention components were implemented as intended for each participating child with complex care needs. The assessment covered the five core components of the SPARKLe care model: (1) identification of children with complex care needs, (2) needs assessment and individualized transition planning, (3) family engagement, (4) structured information transfer to community providers, and (5) post-discharge follow-up within 48 hours. Implementation of each component was assessed and summarized descriptively as the number and proportion of participating cases in which the respective component was implemented as intended.
Measured: From hospital admission through 48 hours after discharge
Implementation barriers and facilitators identified through qualitative interviews and focus groups
Implementation barriers and facilitators related to the SPARKLe care model were explored qualitatively through semi-structured individual interviews with family caregivers and interprofessional focus group interviews with hospital health professionals. Questions addressed experiences with individual SPARKLe intervention components, interdisciplinary collaboration, communication across care settings, family involvement, care coordination processes, and organizational factors influencing implementation. Qualitative data were analyzed using rapid qualitative analysis to identify barriers and facilitators relevant to implementation and intervention refinement.
Measured: During hospitalization through approximately 3 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Apr 2024
- Primary completion31 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Complex Care 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group feasibility study in which all participants receive the SPARKLe nurse-led integrated transitional care model. The study evaluates the implementation of the model in a real-world hospital setting without a comparison group.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Dhaini, PhD, RN, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801911
- Sponsor's protocol ID
- SPARKLe_2024_Feasibility
- Acronym
- SPARKLe
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 3 Sep 2026
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Implementation of the SPARKLe Nurse-led Integrated Transitional Care Model for Children With Complex Care Needs
- ClinicalTrials.gov ID
- NCT07801911
- Acronym / sponsor ID
- SPARKLe / SPARKLe_2024_Feasibility
- Conditions
- Children With Complex Care Needs, Chronic Conditions, Care Coordination, Transitional Care
- Keywords
- SPARKLe, Children with complex care needs, Integrated Care, Tranisitional Care, Implementation, Care Coordination, Feasibility Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Sep 2026 (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 with complex care needs often experience fragmented care during transitions from hospital to home, leading to unmet needs and increased burden on families. The SPARKLe project aims to address this gap through a nurse-led integrated transitional care model. This study evaluates the feasibility of implementing the SPARKLe model in a real-world hospital setting using a mixed-methods design, focusing on implementation outcomes including feasibility, acceptability, adoption, and fidelity.
Detailed description
Children with complex care needs (CCN) often require coordinated care across multiple healthcare providers and settings. Transitions from hospital to home represent particularly vulnerable periods and are frequently characterized by fragmented care, communication gaps, and unclear responsibilities. These challenges can result in unmet needs, duplication of services, increased burden on families, and preventable hospital readmissions.
To address these challenges, the SPARKLe project developed a nurse-led integrated transitional care model designed to improve coordination and continuity of care for children with complex care needs. The model was informed by contextual analysis and stakeholder engagement and is aligned with international frameworks on integrated care as well as national healthcare strategies in Switzerland.
This study evaluates the feasibility of implementing the SPARKLe model in a real-world hospital setting at the University Children's Hospital Zurich. The model includes key components such as early identification of eligible patients, structured needs assessment, active family engagement, standardized information transfer, and follow-up care coordination across settings.
A mixed-methods design was used to assess implementation outcomes, including feasibility, acceptability, adoption, and fidelity. Quantitative data were collected through medical chart reviews, while qualitative data were obtained through interviews with families, focus groups with healthcare professionals, and surveys among community care providers.
The study aims to generate insights into the implementation process, identify barriers and facilitators, and inform further refinement and potential scale-up of the SPARKLe model.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group feasibility study in which all participants receive the SPARKLe nurse-led integrated transitional care model. The study evaluates the implementation of the model in a real-world hospital setting without a comparison group.
| Arm | Type | Receives |
|---|---|---|
| SPARKLe intervention | Experimental | Behavioral: SPARKLe modelParticipants receive the SPARKLe nurse-led integrated transitional care model designed to improve coordination and continuity of care for children with complex care needs during the transition from hospital to home. |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 0 to 16 years with complex care needs
- Admitted to a general pediatric unit at the University Children's Hospital Zurich for more than 24 hours
- Families of eligible children willing to participate in study procedures
- Hospital healthcare professionals involved in the care of included children
- Community healthcare providers involved in post-discharge care of included children
Key exclusion criteria (1 listed)
- Children receiving care within an already established specialized care program at the hospital (e.g., palliative care or oncology care programs) Families declining participation Hospital professionals not directly involved in the care of included children Community providers not involved in the child's post-discharge care
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 |
|---|---|---|
| SPARKLe modelThe SPARKLe model is a nurse-led integrated transitional care intervention for children with complex care needs. It includes key components such as early identification of eligible patients, structured needs assessment, active family engagement, standardized information transfer, and coordination of follow-up care across healthcare settings. | Behavioural | SPARKLe intervention |
Primary outcome
Feasibility of the SPARKLe care model among community providers
Time frame: Approximately 2-3 weeks after hospital discharge.
Feasibility of the SPARKLe care model from the perspective of community providers was assessed using four survey items adapted from the Feasibility of Intervention Measure (FIM), together with selected items informed by the Normalization Measure Development (NoMAD) instrument. NoMAD-informed items assessed coherence, cognitive participation, and collective action related to implementation and integration of the SPARKLe care model into routine practice. Survey items were rated on a five-point Likert scale ranging from strongly disagree to strongly agree.
6 secondary outcomes
Qualitative perceptions of feasibility of the SPARKLe care model
Time frame: During the 4-month feasibility evaluation period, with family caregiver interviews conducted approximately 2 weeks after hospital discharge.
Acceptability of the SPARKLe care model among community providers
Time frame: Approximately 2-3 weeks after hospital discharge
Qualitative perceptions of acceptability of the SPARKLe care model
Time frame: During the 4-month feasibility evaluation period, with family caregiver interviews conducted approximately 2 weeks after hospital discharge.
Early adoption of the SPARKLe care model assessed through healthcare professional focus group interviews
Time frame: During the 4-month implementation period
Proportion of SPARKLe intervention components implemented as intended
Time frame: From hospital admission through 48 hours after discharge
Implementation barriers and facilitators identified through qualitative interviews and focus groups
Time frame: During hospitalization through approximately 3 weeks after discharge
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 3 Sep 2026.
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.
Suzanne Dhaini, PhD, RN principal investigator
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARKLe model in people with Children With Complex Care Needs and Chronic Conditions, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 5 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 3 Sep 2026. 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 Switzerland. 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?
Feasibility of the SPARKLe care model among community providers (time frame: Approximately 2-3 weeks after hospital discharge.). 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 3 Sep 2026.