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Completed

NCT Number: NCT07801911

Feasibility of the Implementation of the SPARKLe Nurse-led Integrated Transitional Care Model for Children With Complex Care Needs

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.

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Key information

Conditions

Children With Complex Care Needs Care Coordination Chronic Conditions Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Transitional Care

Age range

0 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital Zurich

Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

SPARKLe model

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. Acceptability of the SPARKLe care model among community providers

    Time frame: Approximately 2-3 weeks after hospital discharge

    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.

  3. 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.

    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.

  4. Early adoption of the SPARKLe care model assessed through healthcare professional focus group interviews

    Time frame: During the 4-month implementation period

    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.

  5. Proportion of SPARKLe intervention components implemented as intended

    Time frame: From hospital admission through 48 hours after discharge

    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.

  6. Implementation barriers and facilitators identified through qualitative interviews and focus groups

    Time frame: During hospitalization through approximately 3 weeks after discharge

    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.

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Acronym: SPARKLe

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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