Timing of Acute Palliative Care Consultation in Critically Ill Patients

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis; Sepsis; Hepatic Encephalopathy; Parkinson's Disease; Dementia; Multiple Organ Failure; Chronic Kidney Disease Stage 5; Solid Organ Cancer; End Stage Chronic Obstructive Airways Disease; In-Hospital Cardiac Arrest; End Stage Cardiac Failure
• Intervention / Treatment: Other: Early order of palliative care consultation

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Detroit Medical Center Detroit Receiving Hospital
    • Detroit, Michigan, United States, 48235
      • Detroit Medical Center Sinai Grace Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional group (Ig); The interventional group (Ig) will have an early palliative care consultation ordered during their stay in the emergency department.	Other: Early order of palliative care consultation
NO_INTERVENTION: Control group (Cg); 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	Baseline
Amount of hospice referrals in Ig vs. Cg		1 year
Hospital total direct costs for the index visit in Ig vs. Cg		1 year
Hospital and ICU length of stay in Ig vs. Cg		1 year
Average days in hospice in Ig vs. Cg		1 year
Hospital margin contribution for the index visit in Ig vs. Cg		1 year
Time to consultation in Ig vs. Cg groups		1 year

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: Blue Cross Blue Shield of Michigan Foundation
• Investigators: Principal Investigator: Robert Zalenski, M.D., M.A., Wayne State University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): January 1, 2017

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (ESTIMATE): August 8, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 8, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Emergency Department; Palliative Care
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Lung Diseases; Urologic Diseases; Liver Diseases; Renal Insufficiency; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Shock; Brain Diseases, Metabolic; Heart Failure; Multiple Sclerosis; Kidney Diseases; Renal Insufficiency, Chronic; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Parkinson Disease; Hepatic Encephalopathy; Brain Diseases; Multiple Organ Failure
• Other Study ID Numbers: BCBSMF PSACO