Multiple Organ FailureNCT02858778
Timing of Acute Palliative Care Consultation in Critically Ill Patients
A study testing Early order of palliative care consultation in people with Multiple Organ Failure and End Stage Cardiac Failure, run by Wayne State University at 2 sites in United States.
Trial summary
A prospective randomized controlled trial studying the ordering of palliative care consultations in the emergency department (Ig) versus later palliative care consultations in the hospital--ICU or hospital ward(Cg). Patients will be randomly allocated to Ig or Cg with a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Organ Failure, End Stage Cardiac Failure, End Stage Chronic Obstructive Airways Disease
- What is being tested?
- Early order of palliative care consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to Jan 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Greater than or equal to 65 years old
- Treated in a resuscitation room for unstable vital signs or respiratory compromise
- One or more of the following:
- Advanced or metastatic solid organ cancer
- End stage organ failure of the heart, lung/COPD, kidney on dialysis, hepatic encephalopathy
- Suspected sepsis
Show all 9Show fewer
- Advanced dementia, end-state multiple sclerosis or Parkinson's disease
- Status post cardiac arrest with coma (Glascow coma score <7)
- Patient is from a skilled nursing facility
Who cannot join
- Lack decision capacity and have no relative available during ED stay to consent to the study (legally authorized representative-LAR)
- Enrolled in hospice care prior to randomization
- A copy of a completed advance directive which names a designated proxy provided physically to the medical team prior to randomization
- Wearing a DNR bracelet
- Have been previously enrolled in this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Detroit Medical Center Detroit Receiving Hospital
Detroit, Michigan, 48201
Detroit Medical Center Sinai Grace Hospital
Detroit, Michigan, 48235
About this study
Official title: A Randomized Allocation of Palliative Care Consultation in the Emergency Department Compared to Usual Practice
A prospective randomized controlled trial studying the ordering of palliative care consultations in the emergency department (Ig) versus later palliative care consultations in the hospital--ICU or hospital ward(Cg). Patients will be randomly allocated to Ig or Cg with a 1:1 ratio.
- Conditions
- Multiple Organ Failure, End Stage Cardiac Failure, End Stage Chronic Obstructive Airways Disease, Chronic Kidney Disease Stage 5, Hepatic Encephalopathy, Sepsis
- Being tested
- Early order of palliative care consultation
- Keywords
- Palliative Care, Emergency Department
- Medical subject headings
- Multiple Organ Failure, Renal Insufficiency, Chronic, Hepatic Encephalopathy, Sepsis, Dementia, Multiple Sclerosis, Parkinson Disease, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early order of palliative care consultationOther
| Study group | Role | What they receive |
|---|---|---|
| Interventional group (Ig) | Experimental | The interventional group (Ig) will have an early palliative care consultation ordered during their stay in the emergency department. Receives: Other: Early order of palliative care consultation |
| Control group (Cg) | No intervention | The control group will be treated as standard of care. Palliative care consultations may or may not be ordered at the attending physician's discretion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg
Measured: 1 year
Secondary outcomes (9)
The proportion of billed CMS ACP-CPT codes in Ig vs. Cg
The proportion of patients who received an ACP CMS billing codes (which took effect in January 2016), in Ig vs. Cg will be evaluated using one or both of the new CPT codes for Advance care planning (ACP) services…including the explanation and discussion of advance directives such as standard forms (with the completion of such forms, when performed) by the physician or other qualified health profession; first 30 (15-45)minutes, face to face with the patients, family member(s) and/or surrogate Code 99497; and each additional 30 (46-75 minutes)-Code 99498 (Federal Register, 2015).
Measured: 30 days from enrolled patients' hospital discharge
Matches of care received to patient-specific preferences in Ig vs. Cg
The investigators will align treatment preferences with medical orders, replicated as reported in the study by Mack et al. Proportions of patients coded as having a match will be compared across the treatment and control groups. For everyone who gets ACP during the study, patients or their surrogates will be asked by a member of the care team-either palliative care if they are consulted, or the hospital based care team if they are not: "If you could choose, would you prefer (a) treatment that focuses on attempting to extend your time as much as possible, even if doing so means more pain and discomfort, or (b) a plan of care that focuses on relieving pain and discomfort and improving quality of life, even though that may mean not living as long.
Measured: 1 year
Patient/family satisfaction with care in Ig vs. Cg
This outcome will be measured on a continuous scale. The net-promoter score will be measured at baseline (at randomization) and at hospital discharge for a change in value. It is measured on a scale of 1-10. Whoever signs the consent (patient of LAR) will be asked the net promoter score, and that will be reassessed by them at discharge, unless the patient has died-and the variable will then be recorded as missing. The PSQ will be administered by research assistants at the time of the patient's discharge. If the patient is incapacitated, then it will be asked of the patient's closest family caregiver. So PSQ is only at discharge of patient or available, most involved, family caregiver.
Measured: Baseline
Amount of hospice referrals in Ig vs. Cg
Measured: 1 year
Hospital total direct costs for the index visit in Ig vs. Cg
Measured: 1 year
Hospital and ICU length of stay in Ig vs. Cg
Measured: 1 year
Average days in hospice in Ig vs. Cg
Measured: 1 year
Hospital margin contribution for the index visit in Ig vs. Cg
Measured: 1 year
Time to consultation in Ig vs. Cg groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ FailureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Robert Zalenski, Wayne State University
- Investigators
- Robert Zalenski, M.D., M.A., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858778
- Sponsor's protocol ID
- BCBSMF PSACO
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Allocation of Palliative Care Consultation in the Emergency Department Compared to Usual Practice
- ClinicalTrials.gov ID
- NCT02858778
- Acronym / sponsor ID
- BCBSMF PSACO
- Conditions
- Multiple Organ Failure, End Stage Cardiac Failure, End Stage Chronic Obstructive Airways Disease, Chronic Kidney Disease Stage 5, Hepatic Encephalopathy, Sepsis
- Keywords
- Palliative Care, Emergency Department
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- Jun 2016
- Primary completion
- Jan 2017 (estimated)
- First posted
- 8 Aug 2016 (estimated)
- 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.
A prospective randomized controlled trial studying the ordering of palliative care consultations in the emergency department (Ig) versus later palliative care consultations in the hospital--ICU or hospital ward(Cg). Patients will be randomly allocated to Ig or Cg with a 1:1 ratio.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group (Ig) | Experimental | Other: Early order of palliative care consultationThe interventional group (Ig) will have an early palliative care consultation ordered during their stay in the emergency department. |
| Control group (Cg) | No intervention | –The control group will be treated as standard of care. Palliative care consultations may or may not be ordered at the attending physician's discretion. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Greater than or equal to 65 years old
- Treated in a resuscitation room for unstable vital signs or respiratory compromise
- One or more of the following:
- Advanced or metastatic solid organ cancer
- End stage organ failure of the heart, lung/COPD, kidney on dialysis, hepatic encephalopathy
Key exclusion criteria (5 listed)
- Lack decision capacity and have no relative available during ED stay to consent to the study (legally authorized representative-LAR)
- Enrolled in hospice care prior to randomization
- A copy of a completed advance directive which names a designated proxy provided physically to the medical team prior to randomization
- Wearing a DNR bracelet
- Have been previously enrolled in this study
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 |
|---|---|---|
| Early order of palliative care consultation | Other | Interventional group (Ig) |
Primary outcome
The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg
Time frame: 1 year
9 secondary outcomes
The proportion of billed CMS ACP-CPT codes in Ig vs. Cg
Time frame: 30 days from enrolled patients' hospital discharge
Matches of care received to patient-specific preferences in Ig vs. Cg
Time frame: 1 year
Patient/family satisfaction with care in Ig vs. Cg
Time frame: Baseline
Amount of hospice referrals in Ig vs. Cg
Time frame: 1 year
Hospital total direct costs for the index visit in Ig vs. Cg
Time frame: 1 year
Hospital and ICU length of stay in Ig vs. Cg
Time frame: 1 year
Average days in hospice in Ig vs. Cg
Time frame: 1 year
Hospital margin contribution for the index visit in Ig vs. Cg
Time frame: 1 year
Time to consultation in Ig vs. Cg groups
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
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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.
Robert Zalenski, M.D., M.A. principal investigator
Wayne State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early order of palliative care consultation in people with Multiple Organ Failure and End Stage Cardiac Failure, run by Wayne State University at 2 sites 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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2016.