Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT07223918
Status:
COMPLETED
Last Update Posted:
2025-11-03
First Post:
2025-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Decision-Aid to Guide Tracheostomy and Prolonged Mechanical Ventilation Decision-Making
Sponsor:
Denver Health and Hospital Authority
Organization:
Study Overview
Official Title:
Pilot Testing for a Personalized Decision-Aid to Guide Tracheostomy and Prolonged Mechanical Ventilation Decision-Making
Status:
COMPLETED
Status Verified Date:
2025-10
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 goal of this study is to determine the Usability and Acceptability of a personalized online decision support tool for patients, families, and providers considering long-term breathing support options for patients who cannot breathe by themselves. The tool is called TRACH-Support. The key questions are:
1. Is TRACH-Support usable and acceptable to people who make decisions for patients on breathing machines.
2. Is TRACH-Support usable, acceptable, appropriate, and feasible for medical providers, nurses, and respiratory therapists who care for patients on breathing machines.
In this study, family members of patients on a breathing machine and members of the medical team will review the tool and fill out an online survey describing their thoughts about the tool. A subgroup of individuals who fill out the survey will also be asked to participate in qualitative interviews about their experience with the tool.
1. Is TRACH-Support usable and acceptable to people who make decisions for patients on breathing machines.
2. Is TRACH-Support usable, acceptable, appropriate, and feasible for medical providers, nurses, and respiratory therapists who care for patients on breathing machines.
In this study, family members of patients on a breathing machine and members of the medical team will review the tool and fill out an online survey describing their thoughts about the tool. A subgroup of individuals who fill out the survey will also be asked to participate in qualitative interviews about their experience with the tool.
Detailed Description:
This study is primarily designed to assess the Usability and Acceptability of TRACH-Support, a personalized online decision support tool for tracheostomy and prolonged mechanical ventilation, among surrogate decision makers, physicians, advanced practice providers (APPs), nurses, and respiratory therapists. The secondary aim of this study is to determine Appropriateness and Feasibility of implementing TRACH-Support in critical care settings among the healthcare team (physicians, APPs, nurses, and respiratory therapists) and to determine preliminary efficacy at reducing Decisional Conflict among surrogates who use TRACH-Support as compared to historical controls.
The investigators will present TRACH-Support to the above mentioned groups and have them fill out online surveys describing their experience and thoughts with TRACH-Support. A subgroup of individuals will be asked to participate in qualitative interviews to dive deeper into the experience with TRACH-Support and explore potential adaptations prior to wider scale testing.
The investigators will present TRACH-Support to the above mentioned groups and have them fill out online surveys describing their experience and thoughts with TRACH-Support. A subgroup of individuals will be asked to participate in qualitative interviews to dive deeper into the experience with TRACH-Support and explore potential adaptations prior to wider scale testing.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23HL141704 | NIH | None | https://reporter.nih.gov/quic… | View |