Feasibility of the Comfort Measures Only Time Out (CMOT)

Aging Clinical Trial

Official title:

Feasibility of the Comfort Measures Only Time Out (CMOT) to Reduce Distress During Palliative Withdrawal of Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861323
• Other study ID #: 2023P000160
• Secondary ID: K23AG066929
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Corey R Fehnel, MD, MPH
• Phone: 617-667-5345
• Email: cfehnel[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Coma
• Death
• End of Life
• Hypoventilation
• Respiratory Failure
• Respiratory Insufficiency
• Ventilatory Failure

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Hebrew SeniorLife, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Distressful episodes	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.	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).
Primary	Study recruitment rate	Recruitment rate will be determined by the number of eligible participants enrolled divided by the total number of eligible participants.	At time of study completion (approximately 1-year)
Primary	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.	At time of study completion (approximately 1-year)
Secondary	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.	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)