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

NCT07223918 | Completed

• 2 other identifiers: 23-0171K23HL141704
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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. 1.Is TRACH-Support usable and acceptable to people who make decisions for patients on breathing machines.
2. 2.Is TRACH-Support usable, acceptable, appropriate, and feasible for medical providers, nurses, and respiratory therapists who care for patients on breathing machines.

Conditions

Acute Respiratory Failure; Mechanical Ventilation; Tracheostomy

Keywords

acute respiratory failure; prolonged mechanical ventilation; tracheostomy; shared decision-making

Outcome Measures

Primary Outcomes (1)

• System Usability Scale

  The System Usability Scale is a 10-item questionnaire using a 5-level Likert scale designed to assess the usability of systems and interventions. The score ranges from 0-100 with higher numbers indicating greater usability.

  Baseline

Secondary Outcomes (4)

• Acceptability of Intervention Measure

  Baseline

• Feasibility of Intervention Measure

  Baseline

• Intervention Appropriateness Measure

  Baseline

• Decisional Conflict Scale (low literacy)

  Baseline

Study Arms (2)

Surrogates

Surrogate decision-makers are individuals who the primary medical team has determined to be the decision-maker for incapacitated patients on ventilators. Surrogates will be asked to review TRACH-Support if the patient has been receiving mechanical ventilation for \>7 days or has been asked to consider a tracheostomy.

Behavioral: TRACH-Support

Healthcare Team Members

Healthcare team members will include critical care and palliative care physicians, APPs, nurses, and respiratory therapists who work in critical care units and routinely engage in discussions with surrogates about tracheostomy and prolonged mechanical ventilation.

Behavioral: TRACH-Support

Interventions

TRACH-Support BEHAVIORAL

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/).

Healthcare Team Members; Surrogates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will focus on 2 broad groups. Surrogates - Almost all patients receiving mechanical ventilation lack decisional capacity. Therefore, all key medical decisions are made by surrogate decision-makers including decisions related to tracheostomy and PMV. We will recruit surrogate decision-makers identified by the primary medical team to evaluate TRACH-Support for patients who have received MV for 7 days or more or for whom a tracheostomy discussion is planned. Healthcare Team Members - early qualitative data indicates that decision-making often involves the entire healthcare team. Therefore, we will recruit providers, nurses, and respiratory therapists routinely involved in the care of patients receiving MV to evaluate TRACH-Support.

You may qualify if:

• Surrogates
• Age \>18 years
• English or Spanish speaking
• Surrogate decision-maker for a patient who has been receiving mechanical ventilation for greater than or equal to 7 days or in whom a tracheostomy discussion is planned. The role of surrogate decision-maker will be determined by the medical team (can be either a medical decision power of attorney (MDPOA) or proxy decision-maker).
• As many decisions are made by a group of surrogates rather than a single surrogate, up to 3 surrogates per patient will be enrolled.
• Healthcare Team Members
• Age \> 18 years
• A critical care or palliative care physician (MD/DO), advanced practice provider (APP), nurse, or respiratory therapist who routinely engages in tracheostomy and PMV discussions

You may not qualify if:

• Surrogates
• Age \< 18 years
• Non-English or Non-Spanish speaking
• Prisoner
• Healthcare Team Members
• Age \< 18 years
• refuses to evaluate TRACH-Support
• refuses to discuss alternatives to tracheostomy with families

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Related Links

• TRACH-SUpport

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: November 3, 2025
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)