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Palliative Care in the ICU

This study is not yet open for participant recruitment.
Verified August 2017 by Marin Kollef, Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03263143
First Posted: August 28, 2017
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Marin Kollef, Washington University School of Medicine
  Purpose
The study compares early palliative care consultation to standard of care in the medical intensive care unit (ICU). The study will assess if the intervention leads to an increased proportion of clearly delineated goals of care and quality of life and examine if this intervention leads to decreased length of days in the ICU, Hospital, and on mechanical ventilation.

Condition Intervention
Palliative Care Other: Palliative Care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Palliative Care in the Medical Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Marin Kollef, Washington University School of Medicine:

Primary Outcome Measures:
  • ICU Length of Stay [ Time Frame: Through study completion, an average of 6 months ]
  • Hospital Length of Stay [ Time Frame: Through study completion, an average of 6 months ]
  • Number of participants with Cardiopulmonary Resuscitation (CPR) performed [ Time Frame: Through study completion, an average of 6 months ]
  • Days on Mechanical Ventilation [ Time Frame: Through study completion, an average of 6 months ]

Secondary Outcome Measures:
  • Number of participants that transition to comfort care or discharge to hospice [ Time Frame: Through study completion, an average of 6 months ]
  • Total hospital stay cost [ Time Frame: Through study completion, an average of 6 months ]

Estimated Enrollment: 400
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Standard of Care
Early Palliative Care Consultation Other: Palliative Care
Palliative Care Consultation within 24 to 48 hours after admission

Detailed Description:
  • The medical intensive care unit will be split into two groups, assigned as either early palliative care consultation or standard of care. Current standard of care in the ICU is that primary clinician providers determine the need and time for palliative care consultation, which can occur approximately 5 - 14 days after admission.
  • A palliative care screening tool will be used to determine if a newly admitted patient is eligible for palliative care consultation. For patients in the standard of care group, medical records will be reviewed.
  • The two medical ICU groups will be crossed over to the after 3 months for a total of 6 months of study.
  • Participants will be followed through his or her hospitalization.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically-ill patients admitted to the ICU
Criteria

Inclusion Criteria:

  • Admitted to the ICU in the last 24 hours
  • Admitted from Skilled nursing facility (SNF), long term acute care (LTAC)facility, long term ventilator care (vent LTC) unit, or home care with private duty nursing with activity of daily living (ADL) dependencies
  • End-stage dementia, amyotrophic lateral sclerosis, Parkinson's, multiple sclerosis
  • Advanced or Metastatic Cancer
  • Cardiac or respiratory arrest with neurological compromise
  • Multi- organ system failure (more than 2 organ failures)
  • Known diagnosis of end stage organ disease including cirrhosis, end-stage renal disease, congestive heart failure New York Heart Association >III, chronic obstructive pulmonary disease on home O2
  • Shock requiring > 6 hours of vasopressors or inotropes
  • Acute Respiratory failure requiring intubation or BiPAP
  • Admitted to ICU with hospital length of stay of more than 5 days or ICU readmission with the same diagnosis in 30 days.

Exclusion Criteria:

  • Solid Organ or Stem cell transplant patients
  • Patients who do not speak English if interpreter is unavailable
  • Patients without capacity to participate in palliative care discussions without a surrogate available
  • Patients or patient surrogate refusal of palliative care consultation
  • Prior Palliative Care Consultation during the same hospitalization
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263143


Contacts
Contact: Jessica Ma (314) 362-8065 maje@wustl.edu

Locations
United States, Missouri
Barnes Jewish Hospital Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jessica Ma, MD         
Sponsors and Collaborators
Washington University School of Medicine
  More Information

Publications:

Responsible Party: Marin Kollef, Professor, Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03263143     History of Changes
Obsolete Identifiers: NCT03210116
Other Study ID Numbers: 201707067
First Submitted: July 26, 2017
First Posted: August 28, 2017
Last Update Posted: August 28, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No