Feasibility of the Comfort Measures Only Time Out (CMOT) (NCT05861323) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Feasibility of the Comfort Measures Only Time Out (CMOT)
United States184 participantsStarted 2023-10-20
Plain-language summary
Nearly 25% of Americans die in intensive care units (ICUs). Most deaths in ICUs are expected and involve the removal of ventilator support, or palliative withdrawal of mechanical ventilation (WMV). Prior work by the Principal Investigator (PI) found that patient suffering can be common; with 30-59% of patients going through this process experiencing distress. Thus, experts and national organizations have called for evidence to inform guidelines for WMV. This research study will 1) develop and refine a Comfort Measures Only Time out (CMOT) intervention consisting of a structured time out with check-list protocol for the ICU team (nurse, physician, respiratory therapist) to improve the process of WMV. and 2) Pilot test the CMOT intervention in 4 ICUs (2 medical/2 surgical) among 40 WMV patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patient Inclusion Criteria
* Age ≥ 18
* Decision made for withdrawal of mechanical ventilation (WMV) by patient/surrogate and ICU team
* WMV has not yet occurred
Patient Exclusion Criteria
• None
ICU Clinician Inclusion Criteria:
* ICU nurse, Physician/Advance Practice Provider, or respiratory therapist
* Age ≥ 18
* Providing direct care to WMV patient for at least 1-hour pre-extubation
ICU Clinician Exclusion criteria:
• Unable to communicate in English
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is described as a feasibility study — meaning it's testing whether the study itself can be run properly, not yet whether the approach helps patients — so should I understand that we don't yet have strong evidence about whether a 'Comfort Measures Only Time Out' actually improves outcomes for someone in my situation?
2Since the trial involves people facing end-of-life situations, respiratory failure, ventilatory failure, or coma, can you explain what a 'Comfort Measures Only Time Out' actually involves in practice, and how it might affect the care or life-sustaining treatment I or my loved one would receive during the study?
3The trial is listed as active but no longer recruiting new participants — does that mean this specific study is no longer an option for us, and if so, are there similar trials or established comfort-care protocols we should be discussing instead?
4Given that this study is measuring things like recruitment rates and whether staff followed the protocol rather than patient health outcomes, what would my care team actually learn from participating, and how does that weigh against the other treatment paths available to me right now?
5If this trial is focused on end-of-life and serious conditions like coma or ventilatory failure, how would my family be involved in any decisions made during the study, especially if I were unable to speak for myself?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study recruitment rate
Timeframe: At time of study completion (approximately 1-year)
2
Protocol adherence
Timeframe: At time of study completion (approximately 1-year)