ACTIVE_NOT_RECRUITING

Feasibility of the Comfort Measures Only Time Out (CMOT)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-20
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05861323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ICU nurse, Physician/Advance Practice Provider, or respiratory therapist
  2. * Age ≥ 18
  3. * Providing direct care to WMV patient for at least 1-hour pre-extubation
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Corey R Fehnel, MD, MPH
PRINCIPAL_INVESTIGATOR
Co-Director, Neuroscience Intensive Care Unit

Study Locations (Sites)

Beth Israel Deaconess Medical center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • Corey R Fehnel, MD, MPH, PRINCIPAL_INVESTIGATOR, Co-Director, Neuroscience Intensive Care Unit

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-20
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-10-20
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • End of Life
  • Respiratory Failure
  • Ventilatory Failure
  • Coma
  • Aging