Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599398
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-09-15
Brief Title:
Bridging Hospital to Home for Children with Medical Complexity and Their Families
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bridging Hospital to Home for Children with Medical Complexity and Their Families the Effectiveness of a Transitional Care Unit the Jeroen Pit Huis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRIDGE
Brief Summary:
The goal of this observational study is to evaluate an innovative pediatric transitional care unit called the Jeroen Pit Huis JPH The primary objective of our study is to investigate whether an intermediate stay between hospital and home in the JPH have a favourable effect on healthcare consumption patient parent and family-relevant quantitative outcome measures compared to discharge directly from a hospital ward Parents will be asked to complete several questionnaires on three different time points at discharge 3 and 12 months of follow up
Detailed Description:
Rationale Children with Medical Complexities CMC often require 247 expert care for which often prolonged readmissions in a university medical centre UMC are necessary which in turn impedes discharge home Hospital to home transitions of CMC is a multi-faceted process with many challenges and obstacles This protocol describes the evaluation of an innovative Transitional Care Unit TCU called the Jeroen Pit Huis JPH that aims to supports this transition
Hypothesis We hypothesize that an intermediate stay between hospital and home in the JPH will have a favourable effect on healthcare consumption patient parent and family-relevant quantitative outcome measures compared to discharge directly from a hospital ward
Objective The primary objective of our study is to investigate whether an intermediate stay between hospital and home in the JPH lowers parental distress compared to discharge directly from a hospital ward Furthermore the effect on quality of life QoL in children and parents growth family functioning impact on parental employment parental self-efficacy anxiety depression sleep disturbance posttraumatic stress PTSD care satisfaction and healthcare consumption will be assessed with and without an intermediate stay in the JPH
Study design Multicenter quasi-experimental prospective cohort study
Study population Patients term newborns up to the age of 18 years who 1 are admitted in the hospital with a deterioration of a chronic complex condition CCC andor have expected continuous dependence on technology after discharge 2 require specialized medical andor allied health care after discharge 3 are medically stable andor have a set treatment regime and 4 are not yet ready to be discharged home due organization- care- or family circumstances
Intervention if applicable Not applicable since the JPH is the standard of transitional care in the Amsterdam UMC
Main study parametersendpoints
Primary outcome measure at TCUhospital discharge 3 and 12 months of follow-up
1 Parental distress
Secondary outcome measures
2 Quality of Life of children at JPHhospital discharge 3 and 12 months of follow-up
3 Growth parameters weight length head circumference at study inclusion JPHhospital discharge 3 and 12 months of follow-up
4 Impact of having a CMC on parents Quality of Life and family functioning at JPHhospital discharge 3 and 12 months of follow-up
5 Impact on parental employment at 12 months of follow-up
6 Parental self-efficacy anxiety depression sleep disturbance at JPHhospital discharge 3 and 12 months of follow-up
7 Parental Posttraumatic Stress Disorder PTSD at 3 and 12 months of follow-up
8 Satisfaction of the parents with the received care at JPHhospital discharge
9 Healthcare consumption during 12 months of follow-up
Nature and extent of the burden and risks associated with participation benefit and group relatedness Subjects do not benefit personally from study participation This non-therapeutic research with minors will have negligible risks The main burden of participation in this study is the need to complete several questionnaires in total on three different time points The expected required time-investment of the children and their caregivers is approximately 25 hours in total around 50 minutes at 3 different time points Furthermore it requires time and effort from physicians to screen and patients for inclusion
Hypothesis We hypothesize that an intermediate stay between hospital and home in the JPH will have a favourable effect on healthcare consumption patient parent and family-relevant quantitative outcome measures compared to discharge directly from a hospital ward
Objective The primary objective of our study is to investigate whether an intermediate stay between hospital and home in the JPH lowers parental distress compared to discharge directly from a hospital ward Furthermore the effect on quality of life QoL in children and parents growth family functioning impact on parental employment parental self-efficacy anxiety depression sleep disturbance posttraumatic stress PTSD care satisfaction and healthcare consumption will be assessed with and without an intermediate stay in the JPH
Study design Multicenter quasi-experimental prospective cohort study
Study population Patients term newborns up to the age of 18 years who 1 are admitted in the hospital with a deterioration of a chronic complex condition CCC andor have expected continuous dependence on technology after discharge 2 require specialized medical andor allied health care after discharge 3 are medically stable andor have a set treatment regime and 4 are not yet ready to be discharged home due organization- care- or family circumstances
Intervention if applicable Not applicable since the JPH is the standard of transitional care in the Amsterdam UMC
Main study parametersendpoints
Primary outcome measure at TCUhospital discharge 3 and 12 months of follow-up
1 Parental distress
Secondary outcome measures
2 Quality of Life of children at JPHhospital discharge 3 and 12 months of follow-up
3 Growth parameters weight length head circumference at study inclusion JPHhospital discharge 3 and 12 months of follow-up
4 Impact of having a CMC on parents Quality of Life and family functioning at JPHhospital discharge 3 and 12 months of follow-up
5 Impact on parental employment at 12 months of follow-up
6 Parental self-efficacy anxiety depression sleep disturbance at JPHhospital discharge 3 and 12 months of follow-up
7 Parental Posttraumatic Stress Disorder PTSD at 3 and 12 months of follow-up
8 Satisfaction of the parents with the received care at JPHhospital discharge
9 Healthcare consumption during 12 months of follow-up
Nature and extent of the burden and risks associated with participation benefit and group relatedness Subjects do not benefit personally from study participation This non-therapeutic research with minors will have negligible risks The main burden of participation in this study is the need to complete several questionnaires in total on three different time points The expected required time-investment of the children and their caregivers is approximately 25 hours in total around 50 minutes at 3 different time points Furthermore it requires time and effort from physicians to screen and patients for inclusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None