NCT07223918

Personalized Decision-Aid to Guide Tracheostomy and Prolonged Mechanical Ventilation Decision-Making

Pilot Testing for a Personalized Decision-Aid to Guide Tracheostomy and Prolonged Mechanical Ventilation Decision-Making

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 105 (actual)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Acute Respiratory Failure
• Mechanical Ventilation
• Tracheostomy

Interventions

Type	Name	Description
BEHAVIORAL	TRACH-Support	TRACH-Support is a newly developed personalized online decision-support tool designed to support shared decision-making for tracheostomy and prolonged mechanical ventilation decision-making (https://www.patientdecisionaid.org/trachsupport/introduction/).

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2025-11-03
• Last updated: 2025-11-03

Locations

1 site across 1 country: United States