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Palliative Care in the ICU

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ClinicalTrials.gov Identifier: NCT03263143
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Marin Kollef, Washington University School of Medicine

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 Phase
Palliative Care Other: Palliative Care Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Early Palliative Care in the Medical Intensive Care Unit
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : May 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

Arm Intervention/treatment
No Intervention: Standard of Care
Early Palliative Care Consultation Other: Palliative Care
Palliative Care Consultation within 24 to 48 hours after admission



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 that transition to comfort care or discharge to hospice [ Time Frame: Through study completion, an average of 6 months ]

Secondary Outcome Measures :
  1. Total hospital stay cost [ Time Frame: Through study completion, an average of 6 months ]
  2. Number of participants with Cardiopulmonary Resuscitation (CPR) performed [ Time Frame: Through study completion, an average of 6 months ]
  3. Number of participants who change resuscitation preferences [ 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 ]


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
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:

  • All stem cell transplant patients, for solid organ transplant, if undergoing evaluation for solid organ transplant or within 1 year post-transplant.
  • 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

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 Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jessica Ma, MD         
Sponsors and Collaborators
Washington University School of Medicine

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: May 11, 2018
Last Verified: May 2018

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