NCT02858778UnknownNot Applicable
A Randomized Allocation of Palliative Care Consultation in the Emergency Department Compared to Usual Practice
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Wayne State University
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Interventional group (Ig)
Experimental
The interventional group (Ig) will have an early palliative care consultation ordered during their stay in the emergency department.
Intervention: Early order of palliative care consultation (Other)
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.
Outcomes
Primary Outcomes
The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg
Time Frame: 1 year
Secondary Outcomes
- 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)
- 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)
- Time to consultation in Ig vs. Cg groups(1 year)
- Hospital total direct costs for the index visit in Ig vs. Cg(1 year)
Investigators
Robert Zalenski
Principle Investigator
Wayne State University
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung CancerLung CancerNCT03337399Massachusetts General Hospital507
Completed
Not Applicable
Randomized Evaluation of Default Access to Palliative ServicesESRDCOPDDementiaNCT02505035University of Pennsylvania34,239
Completed
Not Applicable
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung CancersLocalized Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Bladder CancerStage IIB Cervical CancerStage IIC Ovarian Epithelial CancerStage IIIA Cervical CancerStage IIIA Rectal CancerStage IIIB Colon CancerStage IIIB Uterine SarcomaStage IIIC Rectal CancerStage IV Ovarian Epithelial CancerStage IV Renal Cell CancerHealthy SubjectMetastatic Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Ovarian Germ Cell TumorRecurrent Uterine SarcomaStage II Urethral CancerStage IIA Ovarian Epithelial CancerStage IIIA Colon CancerStage IIIA Gastric CancerPsychosocial Effects of Cancer and Its TreatmentStage II Renal Cell CancerStage IIA Colon CancerStage IIA Uterine SarcomaStage IIB Gastric CancerStage IIB Ovarian Epithelial CancerStage IIB Ovarian Germ Cell TumorStage IIC Colon CancerStage III Renal Cell CancerStage III Urethral CancerStage IIIA Ovarian Germ Cell TumorStage IIIB Ovarian Epithelial CancerStage IIIC Uterine SarcomaStage IV Pancreatic CancerStage IVA Cervical CancerStage IVA Uterine SarcomaStage IVB Cervical CancerStage IIA Lung CarcinomaStage IIIB Lung CarcinomaRecurrent Cervical CancerRecurrent Gastric CancerRecurrent Ovarian Epithelial CancerRegional Transitional Cell Cancer of the Renal Pelvis and UreterStage II Bladder CancerStage IIA Gastric CancerStage IIA Ovarian Germ Cell TumorStage IIA Pancreatic CancerStage IIB Colon CancerStage IIIA Ovarian Epithelial CancerStage IIIC Ovarian Epithelial CancerStage IV Gastric CancerStage IVB Colon CancerStage IVB Rectal CancerUreter CancerStage IIB Lung CarcinomaRecurrent Colon CancerRecurrent Pancreatic CancerRecurrent Rectal CancerRecurrent Renal Cell CancerRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Urethral CancerStage IIA Cervical CancerStage IIA Rectal CancerStage IIB Pancreatic CancerStage IIB Rectal CancerStage IIB Uterine SarcomaStage IIC Ovarian Germ Cell TumorStage IIC Rectal CancerStage III Bladder CancerStage III Pancreatic CancerStage IIIB Ovarian Germ Cell TumorStage IIIC Ovarian Germ Cell TumorStage IV Urethral CancerStage IVA Rectal CancerStage IVB Uterine SarcomaStage IIIA Lung CarcinomaStage IIIA Uterine SarcomaStage IIIB Cervical CancerStage IIIB Gastric CancerStage IIIB Rectal CancerStage IIIC Colon CancerStage IIIC Gastric CancerStage IV Bladder CancerStage IV Ovarian Germ Cell TumorStage IVA Colon CancerNCT01846520City of Hope Medical Center200
Withdrawn
Not Applicable
Palliative Care Consultation to Improve Communication for Patients Considering Surgery for a Pancreatic NeoplasmPancreatic NeoplasmNCT06545344Fred Hutchinson Cancer Center40
Terminated
Not Applicable
LOTCOL Study: Local Treatment of Colo-rectal Liver MetMetastatic Colo-rectal CancerNCT01867918Oslo University Hospital3