Emergency Department-Based Palliative Care for Advanced Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to: 1) identify the palliative care needs of Emergency Department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ED; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome symptoms and decreases utilization as compared to usual care.

Detailed Description
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As the population ages, the number of individual living with cancer will continue to rise, and the number of Emergency Department (ED) visits for this population will continue to increase. Cancer patients visit EDs because symptoms, such as pain or vomiting, can't be controlled at home, in an assisted living facility, or in their provider's office. The ED is often the only place that can provide the necessary treatments as well as immediate access to technologically advanced testing for those with cancer. However, palliative care (PC) services, such as relief of burdensome symptoms), attention to spiritual or social concerns, and establishing goals of care, is not standard care in the ED outside of a few medical centers. Most patients do not have well-defined goals of care, and are often subjected to painful and marginally effective tests and procedures, not because they are consistent with their goals but because it is less time-consuming than discussing other options and has less perceived legal risk. Until recently little emphasis has been placed on education, research, or guidelines for the delivery of PC services in this important setting. While emergency providers could provide some of these services themselves, knowledge and skills regarding PC as well as staffing are currently inadequate to provide comprehensive services. In addition to further decreasing days spent in the hospital and health care costs, consultation by a PC team for ED cancer patients might also reduce pain and other symptoms, aid in complex medical decision-making regarding testing and treatments, and facilitate transfer to hospice or home with visiting nurse services. To enable PC consultation for ED cancer patients, the investigators will first determine who could benefit from emergent consultation, what services they need, and what characteristics of emergency providers and hospitals are preventing them from being offered. To determine what affect PC consultation for patients with advanced cancer has on symptoms, discussions with patients and families about goals of care, and how long patients spend in the ED, the investigators will then randomly assign 200 ED cancer patients to targeted PC consultation versus usual or standard care.

Official Title
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Emergency Department-Based Palliative Care for Advanced Cancer Patients

Conditions
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Advanced Cancer, Metastatic Cancer

Intervention / Treatment
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* Other: Early palliative care consultation
* Other: Care as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years age Speak English or Spanish ED patient with an advanced solid malignancy Exclusion Criteria: Have already been seen by palliative care team Cognitive deficits Children or adolescents No confirmed history of active cancer Do not speak English or Spanish Reside outside the US

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early palliative care consultation<br>Early palliative care consultation for ED patients with advanced cancer. | Other: Early palliative care consultation<br>* Patients will have symptoms assessed, have goals of care discussion with family and team present, and surrogate designated, as well as coordination of care and home services.<br>|
| Other: Care as usual<br>Care as usual, may or may not receive palliative care consultation | Other: Care as usual<br>* Standard care as usual which may or may not include palliative care consultation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline | Comparison of life and quality of mental health from baseline to 6 weeks and 12 weeks. | at baseline, 6 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inpatient costs per day/cost of stay during hospitalization | Costs per day during incident admission and total cost of entire incident hospital stay | 6 months after hospital discharge | 
| Hospital length of stay | Number of days hospitalized for incident admission: i.e., date of admission and date of discharge, difference between those two dates. | 6 months after hospital discharge | 
| Survival | Survival days from day of enrollment to day of death or study termination | at time of enrollment | 
| Readmissions within 6 months of discharge |  | 6 months from hospital discharge | 
| Repeat visits to the ED in 6 months |  | 6 months from hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliative care, cancer, emergency medicine, end- of- life care