Timing of Acute Palliative Care Consultation in Critically Ill Patients

NCT02858778 | Unknown

• 1 other identifier: BCBSMF PSACO
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Cardiac Failure; Chronic Kidney Disease Stage 5; In-Hospital Cardiac Arrest; Multiple Organ Failure; End Stage Chronic Obstructive Airways Disease; Hepatic Encephalopathy; Sepsis; Dementia; Multiple Sclerosis; Parkinson's Disease; Solid Organ Cancer

Keywords

Palliative Care; Emergency Department

Outcome Measures

Primary Outcomes (1)

• The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg

  1 year

Secondary Outcomes (9)

• The proportion of billed CMS ACP-CPT codes in Ig vs. Cg

  30 days from enrolled patients' hospital discharge

• Matches of care received to patient-specific preferences in Ig vs. Cg

  1 year

• Patient/family satisfaction with care in Ig vs. Cg

  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

Study Arms (2)

Interventional group (Ig)

EXPERIMENTAL

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

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.

Interventions

Early order of palliative care consultation OTHER

Interventional group (Ig)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead
• Blue Cross Blue Shield of Michigan Foundation: collaborator

Study Sites (2)

Detroit Medical Center Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Detroit Medical Center Sinai Grace Hospital

Detroit, Michigan, 48235, United States

Location

MeSH Terms

Conditions

Multiple Organ Failure; Renal Insufficiency, Chronic; Hepatic Encephalopathy; Sepsis; Dementia; Multiple Sclerosis; Parkinson Disease; Emergencies

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Neurocognitive Disorders; Mental Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Robert Zalenski, M.D., M.A.

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 8, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

US (2)