Study protocol testing feasibility of the Comfort Measures Only Time out (CMOT) to reduce distress during palliative withdrawal of mechanical ventilation

doi:10.1186/s40814-025-01688-4

. 2025 Aug 13;11(1):109.

doi: 10.1186/s40814-025-01688-4.

Study protocol testing feasibility of the Comfort Measures Only Time out (CMOT) to reduce distress during palliative withdrawal of mechanical ventilation

Abigail G Fischer¹, Margaret L Campbell², Margaret M Hayes^{1

3

4}, Richard M Schwartzstein^{1

3}, Douglas B White⁵, Susan L Mitchell^{1

3

6}, Corey R Fehnel^{7

8

9}

Affiliations

¹ Beth Israel Deaconess Medical Center, 110 Francis St, Lowry 9A, Boston, 02215, MA , USA.
² Wayne State University, College of Nursing, Detroit, USA.
³ Harvard Medical School, Boston, USA.
⁴ Center for Humanizing the ICU, BIDMC, Boston, USA.
⁵ University of Pittsburgh School of Medicine, Pittsburgh, USA.
⁶ Hebrew SeniorLife, Marcus Institute for Aging Research,, Boston, USA.
⁷ Beth Israel Deaconess Medical Center, 110 Francis St, Lowry 9A, Boston, 02215, MA , USA. cfehnel@bidmc.hardvard.edu.
⁸ Harvard Medical School, Boston, USA. cfehnel@bidmc.hardvard.edu.
⁹ Hebrew SeniorLife, Marcus Institute for Aging Research,, Boston, USA. cfehnel@bidmc.hardvard.edu.

PMID: 40804432
PMCID: PMC12345127
DOI: 10.1186/s40814-025-01688-4

Study protocol testing feasibility of the Comfort Measures Only Time out (CMOT) to reduce distress during palliative withdrawal of mechanical ventilation

Abigail G Fischer et al. Pilot Feasibility Stud. 2025.

. 2025 Aug 13;11(1):109.

doi: 10.1186/s40814-025-01688-4.

Authors

Abigail G Fischer¹, Margaret L Campbell², Margaret M Hayes^{1

3

4}, Richard M Schwartzstein^{1

3}, Douglas B White⁵, Susan L Mitchell^{1

3

6}, Corey R Fehnel^{7

8

9}

Affiliations

¹ Beth Israel Deaconess Medical Center, 110 Francis St, Lowry 9A, Boston, 02215, MA , USA.
² Wayne State University, College of Nursing, Detroit, USA.
³ Harvard Medical School, Boston, USA.
⁴ Center for Humanizing the ICU, BIDMC, Boston, USA.
⁵ University of Pittsburgh School of Medicine, Pittsburgh, USA.
⁶ Hebrew SeniorLife, Marcus Institute for Aging Research,, Boston, USA.
⁷ Beth Israel Deaconess Medical Center, 110 Francis St, Lowry 9A, Boston, 02215, MA , USA. cfehnel@bidmc.hardvard.edu.
⁸ Harvard Medical School, Boston, USA. cfehnel@bidmc.hardvard.edu.
⁹ Hebrew SeniorLife, Marcus Institute for Aging Research,, Boston, USA. cfehnel@bidmc.hardvard.edu.

PMID: 40804432
PMCID: PMC12345127
DOI: 10.1186/s40814-025-01688-4

Abstract

Introduction: Distress is experienced by more than 30% of patients during palliative withdrawal of mechanical ventilation at the end of life in the intensive care unit. There is a lack of high-quality evidence for specific approaches to risk factor identification and management of distress during this process. Structured "time-outs" and checklist interventions improve surgical outcomes and have been widely adopted in procedural care, but they have not been tested for use at end-of-life in intensive care unit settings.

Methods: We describe the development and planned testing of a novel time-out checklist intervention, the Comfort Measures Only Time Out (CMOT) in a non-randomized single arm pilot study. Intervention development was guided by published literature and a structured inter-professional advisory panel. The intervention will be tested by clinical teams caring for 46 patients undergoing palliative withdrawal of mechanical ventilation. Nurses, physicians, advanced practice providers, and respiratory therapists will convene within an hour before withdrawal of mechanical ventilation to complete the checklist. Implementation outcomes, including feasibility, will be measured by a 12-question survey and by clinician protocol adherence. Effect size calculations will determine power for future randomized controlled trials testing efficacy of the CMOT in reducing patient distress.

Discussion: This protocol will pilot test the feasibility of the CMOT, a structured time-out and checklist intervention, for WMV in the ICU. The study will inform potential changes to the protocol and intervention for a future randomized control trial. The CMOT is grounded in a quality and safety framework already adopted in procedural and critical care settings. Given high rates of distress, the CMOT will fill an identified gap in evidence surrounding the process of WMV.

Trial registration: Clinical trials.gov ( NCT05861323 ); 16 May 2023.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The Beth Israel Deaconess Medical Center Committee on Clinical Investigations (CCI/IRB) approved this study (#2023P000160) and will review any protocol changes. The trial is registered on ClinicalTrials.gov (NCT05861323) and with the National Institute on Aging CROMS database (DGCG-10874). Participants will be assigned a unique identifier to protect confidentiality. All study databases will be de-identified and archived at the end of the study. All data are encrypted and stored in secure, password protected research virtual environment accessible only to approved study staff. Consent for publication: All authors read and approved the final manuscript. Competing interests: The authors declare that they have no competing interests.

Figures

**Fig. 1**
Timing of CMOT events and data collection. Legend: The intensive care unit (ICU) team will convene within 1 h of palliative withdrawal of mechanical ventilation (WMV) to complete the Comfort Measures Only Time out (CMOT) check list. The ICU nurse will assess the patient for distress at 10 designated time points (1-h pre-WMV, immediately before and after WMV, every 20 min for 1 h post-WMV, then every 30-min up to 3-h post-WMV). Abbreviations: advanced practice provider (*APP*), Comfort Measures Only Time out (*CMOT*), intensive care unit (*ICU*), withdrawal of mechanical ventilation (*WMV*)

**Fig. 2**
The Comfort Measures Only Time out. Legend: The Comfort Measures Only Time out will be completed by clinical teams caring for patients undergoing palliative withdrawal of mechanical ventilation

See this image and copyright information in PMC

References

1. Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, et al. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004;32:638–43. - PubMed
1. Fulton AT, Gozalo P, Mitchell SL, Mor V, Teno JM. Intensive care utilization among nursing home residents with advanced cognitive and severe functional impairment. J Palliat Med. 2014;17:313–7. - PMC - PubMed
1. Wang SY, Aldridge MD, Gross CP, Canavan M, Cherlin E, Johnson-Hurzeler R, et al. End-of-life care intensity and hospice use. Med Care. 2016;54:672–8. - PMC - PubMed
1. Cook D, Rocker G. Dying with dignity in the intensive care unit. N Engl J Med. 2014;370:2506–14. - PubMed
1. Aslakson RA, Reinke LF, Cox C, Kross EK, Benzo RP, Curtis JR. Developing a research agenda for integrating palliative care into critical care and pulmonary practice to improve patient and family outcomes. J Palliat Med. 2017;20:329–43. - PMC - PubMed

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[1] Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, et al. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004;32:638–43. - PubMed

[2] Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, et al. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004;32:638–43. - PubMed

[3] Fulton AT, Gozalo P, Mitchell SL, Mor V, Teno JM. Intensive care utilization among nursing home residents with advanced cognitive and severe functional impairment. J Palliat Med. 2014;17:313–7. - PMC - PubMed

[4] Fulton AT, Gozalo P, Mitchell SL, Mor V, Teno JM. Intensive care utilization among nursing home residents with advanced cognitive and severe functional impairment. J Palliat Med. 2014;17:313–7. - PMC - PubMed

[5] Wang SY, Aldridge MD, Gross CP, Canavan M, Cherlin E, Johnson-Hurzeler R, et al. End-of-life care intensity and hospice use. Med Care. 2016;54:672–8. - PMC - PubMed

[6] Wang SY, Aldridge MD, Gross CP, Canavan M, Cherlin E, Johnson-Hurzeler R, et al. End-of-life care intensity and hospice use. Med Care. 2016;54:672–8. - PMC - PubMed

[7] Cook D, Rocker G. Dying with dignity in the intensive care unit. N Engl J Med. 2014;370:2506–14. - PubMed

[8] Cook D, Rocker G. Dying with dignity in the intensive care unit. N Engl J Med. 2014;370:2506–14. - PubMed

[9] Aslakson RA, Reinke LF, Cox C, Kross EK, Benzo RP, Curtis JR. Developing a research agenda for integrating palliative care into critical care and pulmonary practice to improve patient and family outcomes. J Palliat Med. 2017;20:329–43. - PMC - PubMed

[10] Aslakson RA, Reinke LF, Cox C, Kross EK, Benzo RP, Curtis JR. Developing a research agenda for integrating palliative care into critical care and pulmonary practice to improve patient and family outcomes. J Palliat Med. 2017;20:329–43. - PMC - PubMed

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Study protocol testing feasibility of the Comfort Measures Only Time out (CMOT) to reduce distress during palliative withdrawal of mechanical ventilation

Affiliations

Study protocol testing feasibility of the Comfort Measures Only Time out (CMOT) to reduce distress during palliative withdrawal of mechanical ventilation

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

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References

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Miscellaneous