Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283953
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-20
First Post:
2024-02-21
Brief Title:
Boosting Resources for Tracheostomy Care at Home
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Boosting Resources and Caregiver Empowerment for Trach Care at Home A Pragmatic Randomized Trial
Status:
ENROLLING_BY_INVITATION
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:
BREATHE
Brief Summary:
The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home The main questions it aims to answer are
What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life work and family activities while safely caring for their child with a tracheostomy at home
How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge
Caregiver participants will be randomly assigned to receive Trach Me Home gold standard discharge program or Trach Me Home with additional components Caregiver participants will complete three surveys over the course of 6 months Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge primary outcome and fewer hospital readmissions at 6 months than those in Trach Me Home arm
What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life work and family activities while safely caring for their child with a tracheostomy at home
How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge
Caregiver participants will be randomly assigned to receive Trach Me Home gold standard discharge program or Trach Me Home with additional components Caregiver participants will complete three surveys over the course of 6 months Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge primary outcome and fewer hospital readmissions at 6 months than those in Trach Me Home arm
Detailed Description:
The study is focused on a rare and medically complex population of children with tracheostomies The study is a Type I hybrid effectiveness-implementation study using a pragmatic randomized trial at six participating sites The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home The main questions it aims to answer are
What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life work and family activities while safely caring for their child with a tracheostomy at home
How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge
Caregiver participants will randomly assigned to the Comparator arm gold standard discharge program or to the Intervention arm gold standard program with other components Caregiver participants will complete three surveys over the course of 6 months The investigators will test two main hypotheses the Intervention arm will have 1 significantly lower caregiver burden at 4 weeks post discharge primary outcome and 2 significantly lower readmissions or emergency room visits at 6 months post discharge than the Comparator arm
The investigators will also survey pediatricians of participating patients at 6 months post discharge and examine whether intervention arm pediatricians have higher satisfaction with discharge communication than those in comparator arm
What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life work and family activities while safely caring for their child with a tracheostomy at home
How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge
Caregiver participants will randomly assigned to the Comparator arm gold standard discharge program or to the Intervention arm gold standard program with other components Caregiver participants will complete three surveys over the course of 6 months The investigators will test two main hypotheses the Intervention arm will have 1 significantly lower caregiver burden at 4 weeks post discharge primary outcome and 2 significantly lower readmissions or emergency room visits at 6 months post discharge than the Comparator arm
The investigators will also survey pediatricians of participating patients at 6 months post discharge and examine whether intervention arm pediatricians have higher satisfaction with discharge communication than those in comparator arm
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IHS-2022C1-26100 | OTHER_GRANT | Patient Centered Outcomes Research Institute PCORI | None |