Palliative CareNCT03263143
Palliative Care in the ICU
A study testing Palliative Care in people with Palliative Care, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Palliative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Palliative Care in the Medical Intensive Care Unit
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
- Conditions
- Palliative Care
- Being tested
- Palliative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative CareOther
Palliative Care Consultation within 24 to 48 hours after admission
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Not described |
| Early Palliative Care Consultation | Other | Not described Receives: Other: Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in code status to do-not-resuscitate/do-not-intubate
As determined by code status orders in the electronic medical record
Measured: Through patient admission until discharge, charts reviewed an average of one month after discharge
Secondary outcomes (13)
Number of participants with Cardiopulmonary Resuscitation (CPR) performed
Measured: Through study completion, an average of 6 months
Mechanical Ventilation usage and duration
Measured: After date of discharge, charts reviewed an average of one month after discharge
Hospital Length of Stay
Measured: After date of discharge, charts reviewed an average of one month after discharge
ICU Length of Stay
Measured: After date of discharge, charts reviewed an average of one month after discharge
In-hospital mortality
Excluding patients transitioned to hospice prior to death
Measured: After date of discharge, charts reviewed an average of one month after discharge
30-day mortality
Including all patients, including those on hospice
Measured: One to two months after patient discharge, verified at study completion
Hospice transition or discharge
Measured: Through patient admission until discharge, charts reviewed an average of one month after discharge
Post-discharge ER visits and/or readmissions
Determined by review of the BJC healthcare system electronic medical record
Measured: One to two months after patient discharge, verified at study completion
Total hospital operating cost
Measured: Through study completion, an average of 6 months
Vasopressor usage and duration
Measured: After date of discharge, charts reviewed an average of one month after discharge
Antibiotic usage and duration
Measured: After date of discharge, charts reviewed an average of one month after discharge
Number of participants treated with hemodialysis
Measured: Through study completion, an average of six months
Number of participants with tracheostomy performed during hospital stay
Measured: Through study completion, an average of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start7 Aug 2017
- Primary completion9 Jun 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marin Kollef, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263143
- Sponsor's protocol ID
- 201707067
- Status last verified
- Jan 2019
- First submitted
- 26 Jul 2017
- Last updated
- 24 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 28306372Aslakson 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 24517300Hsu-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 24603677Khandelwal 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 25574794Kyeremanteng 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 27582396Penrod 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 22202706Mun 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 27644048Braus 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 26556622Ma 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Palliative Care in the Medical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03263143
- Acronym / sponsor ID
- 201707067
- Conditions
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 9 Jun 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | – |
| Early Palliative Care Consultation | Other | Other: Palliative Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative CarePalliative Care Consultation within 24 to 48 hours after admission | Other | Early Palliative Care Consultation |
Primary outcome
Change in code status to do-not-resuscitate/do-not-intubate
Time frame: Through patient admission until discharge, charts reviewed an average of one month after discharge
As determined by code status orders in the electronic medical record
13 secondary outcomes
Number of participants with Cardiopulmonary Resuscitation (CPR) performed
Time frame: Through study completion, an average of 6 months
Mechanical Ventilation usage and duration
Time frame: After date of discharge, charts reviewed an average of one month after discharge
Hospital Length of Stay
Time frame: After date of discharge, charts reviewed an average of one month after discharge
ICU Length of Stay
Time frame: After date of discharge, charts reviewed an average of one month after discharge
In-hospital mortality
Time frame: After date of discharge, charts reviewed an average of one month after discharge
30-day mortality
Time frame: One to two months after patient discharge, verified at study completion
Hospice transition or discharge
Time frame: Through patient admission until discharge, charts reviewed an average of one month after discharge
Post-discharge ER visits and/or readmissions
Time frame: One to two months after patient discharge, verified at study completion
Total hospital operating cost
Time frame: Through study completion, an average of 6 months
Vasopressor usage and duration
Time frame: After date of discharge, charts reviewed an average of one month after discharge
Antibiotic usage and duration
Time frame: After date of discharge, charts reviewed an average of one month after discharge
Number of participants treated with hemodialysis
Time frame: Through study completion, an average of six months
Number of participants with tracheostomy performed during hospital stay
Time frame: Through study completion, an average of six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Background: PubMed 28306372Adelson 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.
- Background: PubMed 24517300Aslakson 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.
- Background: PubMed 24603677Hsu-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.
- Background: PubMed 25574794Khandelwal 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.
- Background: PubMed 27582396Kyeremanteng 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.
- Background: PubMed 22202706Penrod 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.
- Background: PubMed 27644048Mun 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.
- Background: PubMed 26556622Braus 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.
- Derived from this study: PubMed 31609772Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care in people with Palliative Care, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in code status to do-not-resuscitate/do-not-intubate (time frame: Through patient admission until discharge, charts reviewed an average of one month after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03263143, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.