End of LifeNCT05861323
Feasibility of the Comfort Measures Only Time Out (CMOT)
A study testing Comfort Measures Only Time out (CMOT) in people with End of Life and Respiratory Failure, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End of Life, Respiratory Failure, Ventilatory Failure
- What is being tested?
- Comfort Measures Only Time out (CMOT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical center
Boston, Massachusetts, 02215
About this study
Official title: Feasibility of the Comfort Measures Only Time Out (CMOT) to Reduce Distress During Palliative Withdrawal of Mechanical Ventilation
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.
Read the 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
- Being tested
- Comfort Measures Only Time out (CMOT)
- Medical subject headings
- Death, Respiratory Insufficiency, Hypoventilation, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort Measures Only Time out (CMOT)Behavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Comfort Measures Only Time out (CMOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study recruitment rate
Recruitment rate will be determined by the number of eligible participants enrolled divided by the total number of eligible participants.
Measured: 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.
Measured: At time of study completion (approximately 1-year)
Secondary outcomes (1)
Recommendation for future use
Intensive care unit clinicians will complete a brief survey of their experience with the CMOT. The outcome measure will record whether the clinician would "recommend the CMOT be used in the future?" Response options will be recorded in the following categories: Yes, No, Don't Know, Prefer not to answer.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start20 Oct 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End of LifeStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Hebrew SeniorLife
- Responsible party
- Principal investigator, Corey R. Fehnel, Beth Israel Deaconess Medical Center
- Investigators
- Corey R Fehnel, MD, MPH, Principal investigator, Co-Director, Neuroscience Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861323
- Sponsor's protocol ID
- 2023P000160
- Other IDs
- K23AG066929
- Status last verified
- Jun 2026
- First submitted
- 27 Feb 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40804432
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Comfort Measures Only Time Out (CMOT) to Reduce Distress During Palliative Withdrawal of Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05861323
- Acronym / sponsor ID
- 2023P000160
- Conditions
- End of Life, Respiratory Failure, Ventilatory Failure, Coma, Aging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Hebrew SeniorLife
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 16 May 2023 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Check-list Arm | Experimental | Behavioral: Comfort Measures Only Time out (CMOT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Comfort Measures Only Time out (CMOT)Also: CMOTThis 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. | Behavioural | Check-list Arm |
Primary outcome
Study recruitment rate
Time frame: At time of study completion (approximately 1-year)
Recruitment rate will be determined by the number of eligible participants enrolled divided by the total number of eligible participants.
Protocol adherence
Time frame: At time of study completion (approximately 1-year)
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.
1 secondary outcome
Recommendation for future use
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 40804432Fischer 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.
- Individual participant dataSharing planned: No
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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.
Corey R Fehnel, MD, MPH principal investigator
Co-Director, Neuroscience Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comfort Measures Only Time out (CMOT) in people with End of Life and Respiratory Failure, run by Beth Israel Deaconess Medical Center 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?
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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Study recruitment rate (time frame: At time of study completion (approximately 1-year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05861323, which also lists 1 linked publication.
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 18 Jun 2026.