Overview

This trial is active, not recruiting.

Conditions 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
Treatment early order of palliative care consultation
Sponsor Wayne State University
Collaborator Blue Cross Blue Shield of Michigan Foundation
Start date June 2016
End date January 2017
Trial size 120 participants
Trial identifier NCT02858778, BCBSMF PSACO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
The interventional group (Ig) will have an early palliative care consultation ordered during their stay in the emergency department.
early order of palliative care consultation
(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.

Primary Outcomes

Measure
The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg
time frame: 1 year

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title A Randomized Allocation of Palliative Care Consultation in the Emergency Department Compared to Usual Practice
Principal investigator Robert Zalenski, M.D., M.A.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Wayne State University.