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Feasibility of the Comfort Measures Only Time Out (CMOT)

Primary Purpose

End of Life, Respiratory Failure, Ventilatory Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comfort Measures Only Time out (CMOT)
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Check-list Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
February 27, 2023
Last Updated
May 12, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute on Aging (NIA), Hebrew SeniorLife
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1. Study Identification

Unique Protocol Identification Number
NCT05861323
Brief Title
Feasibility of the Comfort Measures Only Time Out (CMOT)
Official Title
Feasibility of the Comfort Measures Only Time Out (CMOT) to Reduce Distress During Palliative Withdrawal of Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute on Aging (NIA), Hebrew SeniorLife

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End of Life, Respiratory Failure, Ventilatory Failure, Coma, Aging

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Check-list Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Comfort Measures Only Time out (CMOT)
Other Intervention Name(s)
CMOT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Study recruitment rate
Description
Recruitment rate will be determined by the number of eligible participants enrolled divided by the total number of eligible participants.
Time Frame
At time of study completion (approximately 1-year)
Title
Protocol adherence
Description
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.
Time Frame
At time of study completion (approximately 1-year)
Secondary Outcome Measure Information:
Title
Recommendation for future use
Description
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.
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)
Other Pre-specified Outcome Measures:
Title
Distressful episodes
Description
The frequency of distressful episodes from the will be measured by trained intensive care unit nurses using the respiratory distress observation scale (RDOS) [Range 0-16, higher scores indicate greater distress] and clinical pain observation tool (CPOT) [Range 0-8, higher scores indicate greater pain]. A composite outcome measure of either RDOS more than 2 or CPOT > 0 will be used to define a distressful episode.
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corey R Fehnel, MD, MPH
Phone
617-667-5345
Email
cfehnel@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey R Fehnel, MD, MPH
Organizational Affiliation
Co-Director, Neuroscience Intensive Care Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Amis
Phone
617-667-1861
Email
eamis@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Corey R Fehnel, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of the Comfort Measures Only Time Out (CMOT)

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