Aging Clinical Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Hebrew SeniorLife, National Institute on Aging (NIA) |
United States,
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) |
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