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CompletedNCT03263143Updated Jan 24, 2019

Palliative Care in the ICU

An interventional study of Palliative Care in Palliative Care, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-24.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 examine if this intervention leads to decreased healthcare resource utilization such as length of stay, duration of intensive treatments including mechanical ventilation, and hospital re-admissions.

Read the 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.
  • Up to two patients per ICU per weekday will be enrolled into the study, due to workload limitations on the palliative care consult team.
  • For patients in the intervention group, a palliative care consultation will be performed within 48 hours of ICU admission and patients will be followed throughout their hospitalization.
  • Patients in the standard of care group will receive usual care. Palliative care may be consulted at the primary team's clinical discretion.
  • The two medical ICU groups will be crossed over after three months with a washout period of six weeks, for a total of approximately eight months of study
  • Electronic medical records will be reviewed after patient discharge to collect data on clinical outcomes as described elsewhere
02

Conditions studied

  • Palliative Care
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
  • For purposes of primary outcome analysis, patients determined to already be DNR/DNI at time of ICU admission
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
242 participants (actual)

Study arms

  • No intervention
    Standard of Care
  • Other
    Early Palliative Care Consultation

    Other: Palliative Care

Interventions

  • OtherPalliative Care

    Palliative Care Consultation within 24 to 48 hours after admission

05

What researchers measure

Primary outcomes

  1. Change in code status to do-not-resuscitate/do-not-intubate

    As determined by code status orders in the electronic medical record

    Time frame: Through patient admission until discharge, charts reviewed an average of one month after discharge

Secondary outcomes

  1. Number of participants with Cardiopulmonary Resuscitation (CPR) performed

    Time frame: Through study completion, an average of 6 months

  2. Mechanical Ventilation usage and duration

    Time frame: After date of discharge, charts reviewed an average of one month after discharge

  3. Hospital Length of Stay

    Time frame: After date of discharge, charts reviewed an average of one month after discharge

  4. ICU Length of Stay

    Time frame: After date of discharge, charts reviewed an average of one month after discharge

  5. In-hospital mortality

    Excluding patients transitioned to hospice prior to death

    Time frame: After date of discharge, charts reviewed an average of one month after discharge

  6. 30-day mortality

    Including all patients, including those on hospice

    Time frame: One to two months after patient discharge, verified at study completion

  7. Hospice transition or discharge

    Time frame: Through patient admission until discharge, charts reviewed an average of one month after discharge

  8. Post-discharge ER visits and/or readmissions

    Determined by review of the BJC healthcare system electronic medical record

    Time frame: One to two months after patient discharge, verified at study completion

  9. Total hospital operating cost

    Time frame: Through study completion, an average of 6 months

  10. Vasopressor usage and duration

    Time frame: After date of discharge, charts reviewed an average of one month after discharge

  11. Antibiotic usage and duration

    Time frame: After date of discharge, charts reviewed an average of one month after discharge

  12. Number of participants treated with hemodialysis

    Time frame: Through study completion, an average of six months

  13. Number of participants with tracheostomy performed during hospital stay

    Time frame: Through study completion, an average of six months

06

Study locations

1 site
  • Barnes Jewish Hospital
    Saint Louis, Missouri 63110, United States
07

References and documents

Publications

  • Adelson K, Paris J, Horton JR, Hernandez-Tellez L, Ricks D, Morrison RS, Smith CB. Standardized Criteria for Palliative Care Consultation on a Solid Tumor Oncology Service Reduces Downstream Health Care Use. J Oncol Pract. 2017 May;13(5):e431-e440. doi: 10.1200/JOP.2016.016808. Epub 2017 Mar 17. PubMed 28306372 ↗
  • Aslakson R, Cheng J, Vollenweider D, Galusca D, Smith TJ, Pronovost PJ. Evidence-based palliative care in the intensive care unit: a systematic review of interventions. J Palliat Med. 2014 Feb;17(2):219-35. doi: 10.1089/jpm.2013.0409. PubMed 24517300 ↗
  • Hsu-Kim C, Friedman T, Gracely E, Gasperino J. Integrating Palliative Care into Critical Care: A Quality Improvement Study. J Intensive Care Med. 2015 Sep;30(6):358-64. doi: 10.1177/0885066614523923. Epub 2014 Mar 5. PubMed 24603677 ↗
  • Khandelwal N, Kross EK, Engelberg RA, Coe NB, Long AC, Curtis JR. Estimating the effect of palliative care interventions and advance care planning on ICU utilization: a systematic review. Crit Care Med. 2015 May;43(5):1102-11. doi: 10.1097/CCM.0000000000000852. PubMed 25574794 ↗
  • Kyeremanteng K, Gagnon LP, Thavorn K, Heyland D, D'Egidio G. The Impact of Palliative Care Consultation in the ICU on Length of Stay: A Systematic Review and Cost Evaluation. J Intensive Care Med. 2018 Jun;33(6):346-353. doi: 10.1177/0885066616664329. Epub 2016 Aug 31. PubMed 27582396 ↗
  • Penrod JD, Pronovost PJ, Livote EE, Puntillo KA, Walker AS, Wallenstein S, Mercado AF, Swoboda SM, Ilaoa D, Thompson DA, Nelson JE. Meeting standards of high-quality intensive care unit palliative care: clinical performance and predictors. Crit Care Med. 2012 Apr;40(4):1105-12. doi: 10.1097/CCM.0b013e3182374a50. PubMed 22202706 ↗
  • Mun E, Ceria-Ulep C, Umbarger L, Nakatsuka C. Trend of Decreased Length of Stay in the Intensive Care Unit (ICU) and in the Hospital with Palliative Care Integration into the ICU. Perm J. 2016 Fall;20(4):16-036. doi: 10.7812/TPP/16-036. Epub 2016 Aug 31. PubMed 27644048 ↗
  • Braus N, Campbell TC, Kwekkeboom KL, Ferguson S, Harvey C, Krupp AE, Lohmeier T, Repplinger MD, Westergaard RP, Jacobs EA, Roberts KF, Ehlenbach WJ. Prospective study of a proactive palliative care rounding intervention in a medical ICU. Intensive Care Med. 2016 Jan;42(1):54-62. doi: 10.1007/s00134-015-4098-1. Epub 2015 Nov 10. PubMed 26556622 ↗
  • Ma J, Chi S, Buettner B, Pollard K, Muir M, Kolekar C, Al-Hammadi N, Chen L, Kollef M, Dans M. Early Palliative Care Consultation in the Medical ICU: A Cluster Randomized Crossover Trial. Crit Care Med. 2019 Dec;47(12):1707-1715. doi: 10.1097/CCM.0000000000004016. PubMed 31609772 ↗
08

Registry details

Key details

Study ID
NCT03263143
Lead sponsor
Washington University School of Medicine
Responsible party
Marin Kollef (Professor, Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine) — Principal investigator
First posted
Aug 28, 2017
Start date
Aug 7, 2017
Primary completion
Jun 9, 2018
Completion
Nov 30, 2018
Last update
Jan 24, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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