Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428175
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-05-20
Brief Title:
Hospital-to-Home Transitional Care Interventions H2H-TCI ChildrenYouth With Special Health Care Needs CYSHCN
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Hospital-to-Home Care Coordination for Children and Youth With Special Health Care Needs
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
H2H-CYSHCN
Brief Summary:
Aim 1 Compare the effectiveness of focused dose vs extended dose hospital-to-home Transitional Care Interventions H2H-TCI on health service use and parent-reported confidence for hospitalized CYSHCN Aim 2 Compare the effectiveness of focused and extended dose H2H-TCI among vulnerable CYSHCN subgroups Hypothesis Both H2H-TCI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity while extended H2H-TCI will better mitigate racialethnic outcome disparities than focused H2H-TCI Aim 3 Evaluate implementation context processes and mechanisms via a multi-phase mixed methods study design
Detailed Description:
Primary Aims Aim 1 Compare the effectiveness of focused dose vs extended dose hospital-to-home Transitional Care Interventions H2H-TCI on health service use and parent-reported confidence for hospitalized CYSHCN
Hypothesis Extended H2H-TCI will be associated with lower acute care use and higher confidence than focused H2H-TCI
Secondary Aims Aim 2 Compare the effectiveness of focused and extended dose H2H-TCI among vulnerable CYSHCN subgroups
Hypothesis Both H2H-TCI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity while extended H2H-TCI will better mitigate racialethnic outcome disparities than focused H2H-TCI
Aim 3 Evaluate implementation context processes and mechanisms via a multi-phase mixed methods study design
The study populations consist of adult parentcaregivers dyad and childrenyouth with special health care needs Participants will be randomized to focused dose intervention after discharge or an extended dose intervention the single dose will receive one phone call from an interventionist post discharge the extended dose group will receive weekly phone calls for one month from an interventionist
Analysis of data from the confidence-mediated and vulnerable patientfamily characteristics-moderated pathways will address Aims 1 and 2 respectively
During extraction of data from each sites Electronic Health Record EHR data security risks will be mitigated by following established standard operating procedures at Duke and the University of North Carolina UNC During preparation of site-based analytical datasets risks will be mitigated by limiting Protected Health Information PHI as much as and as early as is practical All datasets will be stored and reviewed on a secure cloud-based Protected Analytical and Computing Environment PACE at Duke and at UNC in the Secure Research Workspace SRW
The investigators will plan to create a Data Safety and Monitoring Board DSMB that includes expert clinicians who are not active study team members and are independent of the study sponsor The DSMB will oversee the safety of volunteers participating in the study as needed
Hypothesis Extended H2H-TCI will be associated with lower acute care use and higher confidence than focused H2H-TCI
Secondary Aims Aim 2 Compare the effectiveness of focused and extended dose H2H-TCI among vulnerable CYSHCN subgroups
Hypothesis Both H2H-TCI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity while extended H2H-TCI will better mitigate racialethnic outcome disparities than focused H2H-TCI
Aim 3 Evaluate implementation context processes and mechanisms via a multi-phase mixed methods study design
The study populations consist of adult parentcaregivers dyad and childrenyouth with special health care needs Participants will be randomized to focused dose intervention after discharge or an extended dose intervention the single dose will receive one phone call from an interventionist post discharge the extended dose group will receive weekly phone calls for one month from an interventionist
Analysis of data from the confidence-mediated and vulnerable patientfamily characteristics-moderated pathways will address Aims 1 and 2 respectively
During extraction of data from each sites Electronic Health Record EHR data security risks will be mitigated by following established standard operating procedures at Duke and the University of North Carolina UNC During preparation of site-based analytical datasets risks will be mitigated by limiting Protected Health Information PHI as much as and as early as is practical All datasets will be stored and reviewed on a secure cloud-based Protected Analytical and Computing Environment PACE at Duke and at UNC in the Secure Research Workspace SRW
The investigators will plan to create a Data Safety and Monitoring Board DSMB that includes expert clinicians who are not active study team members and are independent of the study sponsor The DSMB will oversee the safety of volunteers participating in the study as needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None