- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07801911
Feasibility of the Implementation of the SPARKLe Nurse-led Integrated Transitional Care Model for Children With Complex Care Needs (SPARKLe)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Zurich, Sveits, 8008
- University Children's Hospital Zurich
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: SPARKLe intervention
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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of the SPARKLe care model among community providers
Tidsramme: Approximately 2-3 weeks after hospital discharge.
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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.
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Approximately 2-3 weeks after hospital discharge.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Qualitative perceptions of feasibility of the SPARKLe care model
Tidsramme: During the 4-month feasibility evaluation period, with family caregiver interviews conducted approximately 2 weeks after hospital discharge.
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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.
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During the 4-month feasibility evaluation period, with family caregiver interviews conducted approximately 2 weeks after hospital discharge.
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Acceptability of the SPARKLe care model among community providers
Tidsramme: Approximately 2-3 weeks after hospital discharge
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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.
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Approximately 2-3 weeks after hospital discharge
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Qualitative perceptions of acceptability of the SPARKLe care model
Tidsramme: During the 4-month feasibility evaluation period, with family caregiver interviews conducted approximately 2 weeks after hospital discharge.
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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.
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During the 4-month feasibility evaluation period, with family caregiver interviews conducted approximately 2 weeks after hospital discharge.
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Early adoption of the SPARKLe care model assessed through healthcare professional focus group interviews
Tidsramme: During the 4-month implementation period
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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.
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During the 4-month implementation period
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Proportion of SPARKLe intervention components implemented as intended
Tidsramme: From hospital admission through 48 hours after discharge
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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.
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From hospital admission through 48 hours after discharge
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Implementation barriers and facilitators identified through qualitative interviews and focus groups
Tidsramme: During hospitalization through approximately 3 weeks after discharge
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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.
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During hospitalization through approximately 3 weeks after discharge
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Suzanne Dhaini, PhD, RN, University Children's Hospital, Zurich
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SPARKLe_2024_Feasibility
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