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Completed

NCT Number: NCT07223918

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

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.

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Key information

Conditions

Acute Respiratory Failure Mechanical Ventilation Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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/).

Primary outcomes

  1. System Usability Scale

    Time frame: Baseline

    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.

Secondary outcomes

  1. Acceptability of Intervention Measure

    Time frame: Baseline

    The Acceptability of Intervention Measure (AIM) is a 4 item measure scored on a 5 point Likert scale designed to assess the acceptability of an intervention to a target population. The cumulative score ranges from 4-20. The mean score for all 4 questions for each individual (ranging from 1-5) is also used frequently. In both situations, higher numbers indicate greater Acceptability.

  2. Feasibility of Intervention Measure

    Time frame: Baseline

    The Feasibility of Intervention Measure (FIM) is 4 item measure scored on a 5 point Likert scale designed to assess the feasibility of implementing a new intervention to a target population. The cumulative score ranges from 4-20. The mean score for all 4 questions for each individual (ranging from 1-5) is also used frequently. In both situations, higher numbers indicate greater Feasibility. This outcome was only assessed among members of the healthcare team.

  3. Intervention Appropriateness Measure

    Time frame: Baseline

    The Intervention Appropriateness Measure (IAM) is a 4 item measure scored on a 5 point Likert scale designed to assess the whether an intervention is appropriate in a given context. The cumulative score ranges from 4-20. The mean score for all 4 questions for each individual (ranging from 1-5) is also used frequently. In both situations, higher numbers indicate greater Appropriateness. This measure was only assessed among members of the healthcare team.

  4. Decisional Conflict Scale (low literacy)

    Time frame: Baseline

    The Decisional Conflict Scale (DCS) is a 10-item questionnaire that assess the conflict an individual experiences with a given decision. Each question offers the responses Yes, No, and Unsure. The DCS score ranges from 0-100 with higher numbers indicating greater decisional conflict. The low literacy scale has been validated for individuals with limited reading or response skills. The DCS is the most common outcome assessed in shared decision-making trials. DCS was only assessed among surrogates.

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2025
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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