CMOT Protocol for End of Life Care

Overseen By Corey R Fehnel, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Unable to communicate in English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve patient care when removing ventilators at the end of life in the ICU. It tests a new approach called Comfort Measures Only Time Out (CMOT), which uses a checklist to help doctors, nurses, and therapists collaborate effectively and focus on patient comfort. Potential participants include those in an ICU where the decision to remove ventilator support has already been made. The trial seeks better ways to reduce patient distress during this difficult process. As an unphased trial, it offers patients the chance to contribute to important research that could enhance end-of-life care practices.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on the process of withdrawing mechanical ventilation in ICU patients.

What prior data suggests that this protocol is safe for end-of-life care?

Research has shown that the Comfort Measures Only Time Out (CMOT) improves communication among ICU staff and enhances patient comfort at the end of life. The CMOT includes a planned "time-out" and a checklist for the ICU team to follow. While specific safety data on CMOT is not available, hospitals commonly use similar checklists to improve care, and they are generally well-accepted.

The study aims to determine if CMOT can help reduce distress in patients gently taken off life support. Since this trial focuses on improving communication and processes, it does not involve new drugs or invasive procedures, resulting in low safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CMOT Protocol for End of Life Care because it aims to enhance communication among ICU teams, which is crucial when making palliative care decisions. Unlike traditional end-of-life care that often focuses solely on patient comfort through medication and support, CMOT introduces a structured "time out" and checklist process. This method encourages ICU teams to pause, discuss, and align on the best ways to ensure patient comfort during the palliative withdrawal of mechanical ventilation. By potentially reducing distressful episodes and improving protocol adherence among clinicians, CMOT could lead to more compassionate and coordinated care for patients at the end of life.

What evidence suggests that the CMOT protocol is effective for end-of-life care?

Research has shown that Comfort Measures Only Time out (CMOT), tested in this trial, can improve care for ICU patients at the end of life. This trial evaluates a checklist and a structured pause with the ICU team to enhance staff communication. Better communication helps make patients more comfortable when withdrawing life support. Palliative care approaches like CMOT aim to ease distressing symptoms patients often face at the end of life. Early findings suggest CMOT may make the withdrawal process less distressing for patients. Overall, CMOT appears promising for creating a more comfortable and supportive environment during these critical moments. ^{1 5 6 7 8}

Who Is on the Research Team?

Corey R Fehnel, MD, MPH

Principal Investigator

Co-Director, Neuroscience Intensive Care Unit

Are You a Good Fit for This Trial?

This trial is for adults over 18 involved in ICU care, including nurses, physicians, and respiratory therapists who will be providing at least one hour of pre-extubation care to patients facing the end of life due to conditions like respiratory failure. Participants must speak English and be part of a team where the decision for withdrawal of mechanical ventilation has been made.

Inclusion Criteria

You are an ICU nurse, doctor, advance practice provider, or respiratory therapist.

I or my surrogate and the ICU team have decided to stop using the breathing machine.

The medical event being studied has not happened yet.

Exclusion Criteria

I cannot communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation and Training

ICU providers are trained on the CMOT intervention and study procedures

1 month

In-person or online training sessions

Pilot Testing

Pilot test the CMOT intervention in 4 ICUs among 40 WMV patients

12 months

Follow-up

Participants are monitored for protocol adherence and distressful episodes

3 hours post-WMV

What Are the Treatments Tested in This Trial?

Interventions

• Comfort Measures Only Time out (CMOT)

Trial Overview The study is testing a new protocol called Comfort Measures Only Time Out (CMOT), which involves a structured time out with a checklist for ICU teams. This aims to improve patient comfort during the process of withdrawing from ventilator support at the end-of-life stage in ICUs.

How Is the Trial Designed?

Group I: Check-list Arm Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Hebrew SeniorLife

Collaborator

Trials

52

Recruited

273,000+

Published Research Related to This Trial

The study involved interviews with eight palliative care experts to explore their experiences and practices regarding Comfort Measures Only (CMO) in hospital settings, revealing significant differences in understanding and implementation of end-of-life care.

Four key themes emerged from the analysis, highlighting the complexities of CMO practices, including the reliance on morphine for comfort, a binary approach to care, and the evolving culture of end-of-life care that emphasizes better support for patients and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The meaning of comfort measures only order sets for hospital-based palliative care providers. Dickerson, SS., Khalsa, SG., McBroom, K., et al.[2022]

A survey of 176 physicians revealed significant disparities in their understanding of 'comfort measures only' (CMO) in patient care, indicating a lack of consensus on its definition and application.

The study highlighted that there is no clear agreement among doctors on the specifics of CMO, such as the level of respiratory support or interventions like laboratory tests and antibiotics, which could lead to inconsistent patient care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comfort measures only: agreeing on a common definition through a survey. Zanartu, C., Matti-Orozco, B.[2012]

Feedback from patient-centered outcome measures (PCOMs) in palliative care significantly enhances processes of care, such as better symptom recognition and increased discussions about quality of life, based on a review of 184 articles involving 70,466 patients.

While PCOMs feedback positively impacts emotional and psychological outcomes for patients, it does not appear to affect overall quality of life or symptom burden, indicating a need for further research in diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capture, transfer, and feedback of patient-centered outcomes data in palliative care populations: does it make a difference? A systematic review. Etkind, SN., Daveson, BA., Kwok, W., et al.[2022]

The Comfort Measures Order Set (CMOS) significantly improved the involvement of spiritual care for dying patients, with 66% of those using CMOS receiving this support compared to only 19% without it (P < .05).

Patients under the CMOS experienced fewer adjustments to symptom management (1.7 adjustments per patient) compared to those not using CMOS (3.3 adjustments per patient), indicating a more stable approach to care, although it did not significantly reduce patient distress at the time of death (P = .11).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Comfort Measures Order Set at a Tertiary Care Academic Hospital: Is There a Comparable Difference in End-of-Life Care Between Patients Dying in Acute Care When CMOS Is Utilized? Lau, C., Stilos, K., Nowell, A., et al.[2018]

Only half of the patients who died in the study were placed on the end-of-life symptom management order (ESMO) protocol, indicating significant missed opportunities for providing comfort care during terminal hospitalization.

Certain patient factors, such as being uninsured or admitted from a nursing home, were associated with a lower likelihood of receiving ESMO protocol care, highlighting areas for quality improvement in end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Missed opportunities: use of an end-of-life symptom management order protocol among inpatients dying expected deaths. Walling, AM., Ettner, SL., Barry, T., et al.[2021]

The implementation of the End-of-Life Symptom Management Order (ESMO) protocol in a hospital setting effectively guided the use of opiate medications for 127 patients, primarily those with a very short life expectancy, enhancing comfort care at the end of life.

While most healthcare providers found the ESMO protocol valuable, some expressed concerns about its timing and their comfort with opiate use, indicating that further improvements are needed to fully optimize end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of implementation of an order protocol for end-of-life symptom management. Walling, AM., Brown-Saltzman, K., Barry, T., et al.[2021]

Patients with 'comfort measures only' (CMO) orders received significantly more family consultations and had a higher rate of do-not-resuscitate/do-not-intubate (DNR/DNI) status compared to those without CMO orders, indicating a shift towards more palliative care practices.

Despite these differences, CMO orders did not lead to significant changes in medication prescribing or treatment interventions, suggesting that simply having a CMO order is not enough to ensure comprehensive end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of writing "comfort measures only" orders in a community teaching hospital. Walker, KA., Peltier, H., Mayo, RL., et al.[2010]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12345127/

Study protocol testing feasibility of the Comfort Measures Only ... This study is designed to improve end of life care in the Intensive Care Unit (ICU) by pilot testing an inter-professional team-based checklist ...

2. trialx.com trialx.com/clinical-trials/listings/257782/feasibility-of-the-comfort-measures-only-time-out-cmot/

Feasibility of the Comfort Measures Only Time Out (CMOT) The RA will collaborate with the CMOT Champion to compile a list of 'targeted' providers for training including ICU nurses, physicians, ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMra1411746

Comfort Care for Patients Dying in the Hospital For hospitalized patients whose death is imminent, palliative care can alleviate distressing symptoms that are common during the last few days or weeks of life.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2564022/

Improving comfort and communication in the ICU A practical set of measures for routine monitoring, performance feedback, and improvement in the quality of palliative care in the intensive care unit (ICU).

5. repository.arizona.edu repository.arizona.edu/handle/10150/668115

Comfort Measures Only Time-Out with a Checklist The CMO time-out with a checklist consisted of an educational session followed by a presurvey and a postsurvey design.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05861323

Feasibility of 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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40804432/

Study protocol testing feasibility of the Comfort Measures Only ... Structured "time-outs" and checklist interventions improve surgical outcomes and have been widely adopted in procedural care, but they have not ...

8. researchgate.net researchgate.net/publication/394472356_Study_protocol_testing_feasibility_of_the_Comfort_Measures_Only_Time_out_CMOT_to_reduce_distress_during_palliative_withdrawal_of_mechanical_ventilation

Study protocol testing feasibility of the Comfort Measures ... Structured “time-outs” and checklist interventions improve surgical outcomes and have been widely adopted in procedural care, but they have not ...