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Palliative Care in the ICU

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ClinicalTrials.gov Identifier: NCT03263143
Recruitment Status : Not yet recruiting
First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Palliative Care Other: Palliative Care

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.

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Palliative Care in the Medical Intensive Care Unit
Anticipated Study Start Date : September 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Standard of Care
Early Palliative Care Consultation Other: Palliative Care
Palliative Care Consultation within 24 to 48 hours after admission


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: August 28, 2017    Key Record Dates
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