Back to resultsTiming of Acute Palliative Care Consultation in Critically Ill Patients
Primary Purpose
Multiple Organ Failure, End Stage Cardiac Failure, End Stage Chronic Obstructive Airways Disease
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early order of palliative care consultation
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Organ Failure focused on measuring Palliative Care, Emergency Department
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Detroit Medical Center Detroit Receiving Hospital
- Detroit Medical Center Sinai Grace Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional group (Ig)
Control group (Cg)
Arm Description
The interventional group (Ig) will have an early palliative care consultation ordered during their stay in the emergency department.
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.
Outcomes
Primary Outcome Measures
The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg
Secondary Outcome Measures
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).
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.
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.
Amount of hospice referrals in Ig vs. Cg
Hospital total direct costs for the index visit in Ig vs. Cg
Hospital and ICU length of stay in Ig vs. Cg
Average days in hospice in Ig vs. Cg
Hospital margin contribution for the index visit in Ig vs. Cg
Time to consultation in Ig vs. Cg groups
Full Information
NCT ID
NCT02858778
First Posted
July 20, 2016
Last Updated
August 3, 2016
Sponsor
Wayne State University
Collaborators
Blue Cross Blue Shield of Michigan Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02858778
Brief Title
Timing of Acute Palliative Care Consultation in Critically Ill Patients
Official Title
A Randomized Allocation of Palliative Care Consultation in the Emergency Department Compared to Usual Practice
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
Blue Cross Blue Shield of Michigan Foundation
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Organ Failure, End Stage Cardiac Failure, End Stage Chronic Obstructive Airways Disease, Chronic Kidney Disease Stage 5, Hepatic Encephalopathy, Sepsis, Dementia, Multiple Sclerosis, Parkinson's Disease, In-Hospital Cardiac Arrest, Solid Organ Cancer
Keywords
Palliative Care, Emergency Department
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional group (Ig)
Arm Type
Experimental
Arm Description
The interventional group (Ig) will have an early palliative care consultation ordered during their stay in the emergency department.
Arm Title
Control group (Cg)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Early order of palliative care consultation
Primary Outcome Measure Information:
Title
The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The proportion of billed CMS ACP-CPT codes in Ig vs. Cg
Description
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).
Time Frame
30 days from enrolled patients' hospital discharge
Title
Matches of care received to patient-specific preferences in Ig vs. Cg
Description
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.
Time Frame
1 year
Title
Patient/family satisfaction with care in Ig vs. Cg
Description
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.
Time Frame
Baseline
Title
Amount of hospice referrals in Ig vs. Cg
Time Frame
1 year
Title
Hospital total direct costs for the index visit in Ig vs. Cg
Time Frame
1 year
Title
Hospital and ICU length of stay in Ig vs. Cg
Time Frame
1 year
Title
Average days in hospice in Ig vs. Cg
Time Frame
1 year
Title
Hospital margin contribution for the index visit in Ig vs. Cg
Time Frame
1 year
Title
Time to consultation in Ig vs. Cg groups
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Zalenski, M.D., M.A.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Detroit Medical Center Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Detroit Medical Center Sinai Grace Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
12. IPD Sharing Statement
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Timing of Acute Palliative Care Consultation in Critically Ill Patients
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