Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867395
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2021-04-28
Brief Title:
A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
The overarching objective of this study is to make it easier for parents of children with medical complexity CMC to take care of their children after discharge home from the hospital and reduce the chance of post-hospitalization morbidity meaning bad outcomes such as readmissions after discharge CMC or those with multiple chronic conditions progressive conditions or technology dependence are at high risk for post-hospitalization morbidity
Detailed Description:
This study will take place in 3 phases at 2 sites Bellevue Hospital Center BHC and Hassenfeld Childrens Hospital HCH Parents of CMC with a prior or current admission will be recruited at these two sites as well as pediatricians who care for these children in the inpatient setting for the following 3 aims
In Aim 1 parents of CMC and pediatricians will be interviewed to understand their views on what makes it challenging and what can make it easier for parents to understand and follow the instructions they get from the hospital about how to take care of their CMC after leaving the hospital The study team will also ask pediatricians what may make it difficult to provide relevant education to families
In Aim 2 a tool will be designed to make it easier for parents to understand and follow the discharge instructions for their CMC The study team will use structure of existing tool findings from Aim 1 and extensive interviews and testing of the tool with parents and pediatricians as the new tool is designed
In Aim 3 a randomized controlled trial RCT will be conducted to study the impact of the tool on parent comprehension and adherence or how well they can follow their childs discharge instructions as well as its impact on post-discharge morbidity such as readmissions and emergency department visits Parents will be randomized to either receive usual hospital care and instructions or the interventiontool in addition to the usual care and instructions The study team will also ask parents who receive the intervention about its usability
In Aim 1 parents of CMC and pediatricians will be interviewed to understand their views on what makes it challenging and what can make it easier for parents to understand and follow the instructions they get from the hospital about how to take care of their CMC after leaving the hospital The study team will also ask pediatricians what may make it difficult to provide relevant education to families
In Aim 2 a tool will be designed to make it easier for parents to understand and follow the discharge instructions for their CMC The study team will use structure of existing tool findings from Aim 1 and extensive interviews and testing of the tool with parents and pediatricians as the new tool is designed
In Aim 3 a randomized controlled trial RCT will be conducted to study the impact of the tool on parent comprehension and adherence or how well they can follow their childs discharge instructions as well as its impact on post-discharge morbidity such as readmissions and emergency department visits Parents will be randomized to either receive usual hospital care and instructions or the interventiontool in addition to the usual care and instructions The study team will also ask parents who receive the intervention about its usability
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