Feasibility of the Comfort Measures Only Time Out (CMOT)

NCT05861323 | Active Not Recruiting DMC

• 2 other identifiers: 2023P000160K23AG066929
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End of Life; Respiratory Failure; Ventilatory Failure; Coma; Aging

Outcome Measures

Primary Outcomes (2)

• Study recruitment rate

  Recruitment rate will be determined by the number of eligible participants enrolled divided by the total number of eligible participants.

  At time of study completion (approximately 1-year)

• Protocol adherence

  Protocol adherence will be measured by the rate of completed CMOT check-lists among enrolled participants. This measure will be calculated as: the number of ICU clinician participants completing CMOT checklist divided by the number enrolled ICU clinician study participants.

  At time of study completion (approximately 1-year)

Secondary Outcomes (1)

• Recommendation for future use

  Surveys will be completed at three hours of withdrawal of mechanical ventilation, or within 72-hours. The measure will be reported at time of study completion (approximately 1-year)

Other Outcomes (1)

• Distressful episodes

  Measurement will occur at the time of withdrawal of mechanical ventilation (WMV) and until death or three hours after WMV. The measure will be reported at time of study completion (approximately 1-year).

Study Arms (1)

Check-list Arm

EXPERIMENTAL

This feasibility study will test an ICU team-based time and and check-list intervention, the Comfort Measures Only Time Out (CMOT). The CMOT is designed to improve ICU team communication and better address patient comfort at the end of life. Participants in the CMOT are intensive care unit clinicians who are caring for a patient who is about to undergo palliative withdrawal of mechanical ventilation at the end of life. Feasibility will be assessed by: recruitment rates, protocol adherence, and acceptability to clinicians. Patient level outcomes such as distressful episodes/person-time alive will also be collected as a component of routine care in this exploratory analysis. The maximum time any participant (ICU clinician or patient) will be participating in the study is about four hours.

Behavioral: Comfort Measures Only Time out (CMOT)

Interventions

Comfort Measures Only Time out (CMOT) BEHAVIORAL

This is a brief intensive care unit team (nurse, physician, advanced practice provider, respiratory therapist) intervention to improve communication and care of patients at end of life in the intensive care unit setting.

Also known as: CMOT

Check-list Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Decision made for withdrawal of mechanical ventilation (WMV) by patient/surrogate and ICU team
• WMV has not yet occurred

You may not qualify if:

• None
• ICU nurse, Physician/Advance Practice Provider, or respiratory therapist
• Age ≥ 18
• Providing direct care to WMV patient for at least 1-hour pre-extubation
• Unable to communicate in English

Sponsors & Collaborators

• Hebrew SeniorLife: collaborator
• Beth Israel Deaconess Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Beth Israel Deaconess Medical center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Fischer AG, Campbell ML, Hayes MM, Schwartzstein RM, White DB, Mitchell SL, Fehnel CR. Study protocol testing feasibility of the Comfort Measures Only Time out (CMOT) to reduce distress during palliative withdrawal of mechanical ventilation. Pilot Feasibility Stud. 2025 Aug 13;11(1):109. doi: 10.1186/s40814-025-01688-4.

  PMID: 40804432 DERIVED

MeSH Terms

Conditions

Death; Respiratory Insufficiency; Hypoventilation; Coma

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Corey R Fehnel, MD, MPH

  Co-Director, Neuroscience Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief, Neurocritical Care and Hospital Neurology

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: May 16, 2023
• Study Start: October 20, 2023
• Primary Completion: August 27, 2024
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)