Overseen ByCorey R Fehnel, MD, MPH
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Beth Israel Deaconess Medical Center
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a new method called Comfort Measures Only Time Out (CMOT) for ICU teams. It involves a structured pause and checklist to ensure patients are comfortable when their ventilator is removed. The goal is to reduce distress in patients during this process.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It focuses on the process of withdrawing mechanical ventilation in ICU patients.
What data supports the effectiveness of the treatment Comfort Measures Only Time out (CMOT) for end-of-life care?
Research shows that using standardized protocols like the comfort measures order set (CMOS) can help manage symptoms and needs of patients who are nearing the end of life, improving their care in hospitals.
12345Is Comfort Measures Only (CMO) safe for end-of-life care?
The research does not provide specific safety data for Comfort Measures Only (CMO) in end-of-life care, but it is a commonly used approach in hospitals to focus on comfort for patients who are likely to die.
12346How does the CMOT Protocol for End of Life Care differ from other treatments?
The CMOT Protocol for End of Life Care is unique because it uses a standardized framework to focus on comfort and symptom management for patients who are likely to die soon. Unlike other treatments that may not have a clear or consistent approach, this protocol aims to ensure that comfort measures are applied in a timely and effective manner, addressing the specific needs of imminently dying patients.
12347Eligibility Criteria
This trial is for adults over 18 involved in ICU care, including nurses, physicians, and respiratory therapists who will be providing at least one hour of pre-extubation care to patients facing the end of life due to conditions like respiratory failure. Participants must speak English and be part of a team where the decision for withdrawal of mechanical ventilation has been made.Inclusion Criteria
I or my surrogate and the ICU team have decided to stop using the breathing machine.
I am 18 years old or older.
I have cared for a ventilated patient for at least 1 hour before they were taken off the ventilator.
Exclusion Criteria
I cannot communicate in English.
Participant Groups
The study is testing a new protocol called Comfort Measures Only Time Out (CMOT), which involves a structured time out with a checklist for ICU teams. This aims to improve patient comfort during the process of withdrawing from ventilator support at the end-of-life stage in ICUs.
1Treatment groups
Experimental Treatment
Group I: Check-list ArmExperimental Treatment1 Intervention
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Beth Israel Deaconess Medical centerBoston, MA
Loading ...
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
National Institute on Aging (NIA)Collaborator
Hebrew SeniorLifeCollaborator
References
The meaning of comfort measures only order sets for hospital-based palliative care providers. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE"> Comfort Measures Only (CMO) is a label commonly used in the USA that guides the care of a hospitalized patient who is likely to die. The CMO label has unclear and inconsistent meaning, calling to question the experiences and practices of hospital-basedalliative care providers. The purpose of this study was to understand the meaning of CMO as experienced by hospital-based palliative care providers.
Missed opportunities: use of an end-of-life symptom management order protocol among inpatients dying expected deaths. [2021]When a patient is expected to die, the ideal plan of care focuses on comfort. Prior investigation of application of one institution's end-of-life symptom management order (ESMO) protocol suggested that comfort measures were often instituted too late and sometimes not at all. We studied patient factors associated with missed opportunities for use of an ESMO protocol and protocol adherence in order to identify areas for quality improvement.
Impact of writing "comfort measures only" orders in a community teaching hospital. [2010]We compared end-of-life care for patients with and without orders for "comfort measures only" (CMO) and evaluated whether standards for palliative medicine were met.
The Comfort Measures Order Set at a Tertiary Care Academic Hospital: Is There a Comparable Difference in End-of-Life Care Between Patients Dying in Acute Care When CMOS Is Utilized? [2018]Standardized protocols have been previously shown to be helpful in managing end-of-life (EOL) care in hospital. The comfort measures order set (CMOS), a standardized framework for assessing imminently dying patients' symptoms and needs, was implemented at a tertiary academic hospital.
Capture, transfer, and feedback of patient-centered outcomes data in palliative care populations: does it make a difference? A systematic review. [2022]Patient-centered outcome measures (PCOMs) are an important way of promoting patient-professional communication. However, evidence regarding their implementation in palliative care is limited, as is evidence of the impact on care quality and outcomes.
Comfort measures only: agreeing on a common definition through a survey. [2012]Despite how frequently we say "comfort measures only" (CMO) in the hospital setting, review of the medical literature yields poor representation and definition of the term. Through a survey in our hospital center, we aimed at understanding what doctors understand as CMO. A total of 176 physicians responded to the survey. We asked them about the moment in the patient care timeline when to use it and what degree of respiratory support, laboratory draws, antibiotic therapy, level of care, and code status should be a part of it. Disparities in responses were the norm, and common defining characteristics were the exception.
Assessment of implementation of an order protocol for end-of-life symptom management. [2021]Designing comfort care plans to treat symptoms at the end-of-life in the hospital is challenging. We evaluated the implementation of an inpatient end-of-life symptom management order (ESMO) protocol that guides the use of opiate medications and other modalities to provide palliation.