Feasibility of the Comfort Measures Only Time Out (CMOT)

NCT ID: NCT05861323

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2026-08-31

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.

Detailed Description

This study will field test an ICU team-based timeout and checklist intervention, the Comfort Measures Only Time Out (CMOT), in 6 cases with 2 ICU teams (3 cases/team) and then further refine based on ICU team and expert feedback to create a final version of the CMOT. Then pilot testing of the final CMOT intervention will occur in 4 ICUs (2 medical/2 surgical) among 40 WMV patients (20/ICU sub-type). There are two groups of human subjects for this study: 1) Patients (n=46)- eligibility criteria are: 1. age ≥ 18, 2. decision made for WMV by extubation (but not yet extubated). and 2) ICU clinicians (n= approximately 138) (ICU nurses, physicians/APPs, and respiratory therapists)- eligibility will include: 1. Age > 18, and 2. provision of direct care to the patient for at least 1-hour pre-extubation. Verbal consent will be obtained from ICU clinicians by the RA. During the preparation period, the research team will conduct seminars to inform the ICU team about the study recruitment and data collection procedures. Each morning during the 12-month recruitment period, a research assistant (RA) will ask the ICU team to identify potentially eligible patients.

Study Procedures:

Pilot-testing of the CMOT will be in 4 ICUs (2 medical/2 surgical) among 40 WMV patients (20 patients/ICU type). Feasibility will be assessed by: recruitment, protocol adherence, acceptability to providers (e.g. helpfulness, endorse future use), and outcome measurement: rates of distressful episodes/person time alive (primary outcome). Outcomes will be compared with OBSERVE-WMV historical controls to help inform the design of a larger trial.

ICU sites: The CMOT intervention will be delivered at the ICU team level in 2 medical ICUs (16 beds), and 2 surgical ICUs at BIDMC (22 beds). Each ICU will have a designated CMOT champion.

ICU provider training:

The RA will collaborate with the CMOT Champion to compile a list of 'targeted' providers for training including ICU nurses, physicians, residents/fellows, mid-level providers, and respiratory therapists expected to provide care in the ICU over the next 13 months. The list will be refreshed every 2 months to reach new staff. The goal will be to have all targeted providers complete either the in-person or online training seminar (see below) within one month from the initial start-up for "prevalent" providers, or from start time in the ICU for new providers. The RA will track provider participation based on seminar sign-in logs or online training completion (see below). Weekly reminders will be emailed to non-compliant providers. It is estimated there will be ~50-60 targeted providers per ICU (20-25 nurses, 10-15 physicians, 10-15 fellows/resident physicians/mid-level providers, and 5 respiratory therapists). Provider involvement will be voluntary with verbal informed consent obtained during orientation.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Check-list Arm

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.

Group Type: EXPERIMENTAL

Comfort Measures Only Time out (CMOT)

Intervention Type: 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.

Interventions

Comfort Measures Only Time out (CMOT)

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CMOT

Eligibility Criteria

Inclusion Criteria

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

• ICU nurse, Physician/Advance Practice Provider, or respiratory therapist
• Age ≥ 18
• Providing direct care to WMV patient for at least 1-hour pre-extubation

Exclusion Criteria

• None

• Unable to communicate in English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Hebrew SeniorLife

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Corey R. Fehnel

Division Chief, Neurocritical Care and Hospital Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Corey R Fehnel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Co-Director, Neuroscience Intensive Care Unit

Locations

Beth Israel Deaconess Medical center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40804432 (View on PubMed)

Other Identifiers

K23AG066929

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023P000160

Identifier Type: -

Identifier Source: org_study_id