Acute Respiratory FailureNCT07223918
Personalized Decision-Aid to Guide Tracheostomy and Prolonged Mechanical Ventilation Decision-Making
An observational study of Acute Respiratory Failure and Mechanical Ventilation, run by Denver Health and Hospital Authority at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Failure, Mechanical Ventilation, Tracheostomy
- What is being tested?
- TRACH-Support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health and Hospital Authority
Denver, Colorado, 80204
About this study
Official title: Pilot Testing for a 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:
- Is TRACH-Support usable and acceptable to people who make decisions for patients on breathing machines.
- 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.
Read the 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.
- Being tested
- TRACH-Support
- Keywords
- acute respiratory failure, prolonged mechanical ventilation, tracheostomy, shared decision-making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRACH-SupportBehavioural
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/).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: TRACH-Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
Acceptability of Intervention Measure
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.
Measured: Baseline
Feasibility of Intervention Measure
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.
Measured: Baseline
Intervention Appropriateness Measure
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.
Measured: Baseline
Decisional Conflict Scale (low literacy)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start1 Jan 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223918
- Sponsor's protocol ID
- 23-0171
- Other IDs
- K23HL141704
- Status last verified
- Oct 2025
- First submitted
- 29 Oct 2025
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As an observational study we do not plan on sharing individual participant data outside of the research team other than de-identified quotes from qualitative interviews.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing for a Personalized Decision-Aid to Guide Tracheostomy and Prolonged Mechanical Ventilation Decision-Making
- ClinicalTrials.gov ID
- NCT07223918
- Acronym / sponsor ID
- 23-0171
- Keywords
- acute respiratory failure, prolonged mechanical ventilation, tracheostomy, shared decision-making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is TRACH-Support usable and acceptable to people who make decisions for patients on breathing machines.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surrogates | – | Behavioral: TRACH-SupportSurrogate 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. |
| Healthcare Team Members | – | Behavioral: TRACH-SupportHealthcare 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- Surrogates
- Age < 18 years
- Non-English or Non-Spanish speaking
- Prisoner
- Healthcare Team Members
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRACH-SupportTRACH-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/). | Behavioural | Healthcare Team Members, Surrogates |
Primary outcome
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.
4 secondary outcomes
Acceptability of Intervention Measure
Time frame: Baseline
Feasibility of Intervention Measure
Time frame: Baseline
Intervention Appropriateness Measure
Time frame: Baseline
Decisional Conflict Scale (low literacy)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- TRACH-SUpportLink provided by the sponsor.
- Individual participant dataSharing planned: No. As an observational study we do not plan on sharing individual participant data outside of the research team other than de-identified quotes from qualitative interviews.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Mechanical Ventilation, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.