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

NCT ID: NCT07223918

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-06-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

TRACH-Support

Intervention Type: 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

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.

TRACH-Support

Intervention Type: 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/).

Interventions

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/).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Denver Health and Hospital Authority

Denver, Colorado, United States

Countries

United States

Related Links

https://www.patientdecisionaid.org/trachsupport/introduction/

TRACH-SUpport

Other Identifiers

K23HL141704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-0171

Identifier Type: -

Identifier Source: org_study_id