Timing of Acute Palliative Care Consultation in Critically Ill Patients

Multiple Sclerosis Clinical Trial

Official title:

A Randomized Allocation of Palliative Care Consultation in the Emergency Department Compared to Usual Practice

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02858778
• Other study ID #: BCBSMF PSACO
• Status: Active, not recruiting
• Phase: N/A
• First received: July 20, 2016
• Last updated: August 3, 2016
• Start date: June 2016

Study information

• Verified date: August 2016
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain Diseases
• Chronic Kidney Disease Stage 5
• Dementia
• End Stage Cardiac Failure
• End Stage Chronic Obstructive Airways Disease
• Heart Arrest
• Heart Failure
• Hepatic Encephalopathy
• In-Hospital Cardiac Arrest
• Kidney Diseases
• Lung Diseases, Obstructive
• Multiple Organ Failure
• Multiple Sclerosis
• Parkinson Disease
• Parkinson's Disease
• Pulmonary Disease, Chronic Obstructive
• Renal Insufficiency, Chronic
• Sepsis
• Solid Organ Cancer

Intervention

Other:
• Early order of palliative care consultation

Locations

Country	Name	City	State
United States	Detroit Medical Center Detroit Receiving Hospital	Detroit	Michigan
United States	Detroit Medical Center Sinai Grace Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg		1 year	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Amount of hospice referrals in Ig vs. Cg		1 year	No
Secondary	Hospital total direct costs for the index visit in Ig vs. Cg		1 year	No
Secondary	Hospital and ICU length of stay in Ig vs. Cg		1 year	No
Secondary	Average days in hospice in Ig vs. Cg		1 year	No
Secondary	Hospital margin contribution for the index visit in Ig vs. Cg		1 year	No
Secondary	Time to consultation in Ig vs. Cg groups		1 year	No