Emergency Medicine Palliative Care Access

Study Overview
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Brief Summary
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This is a two-arm, multi-site randomized controlled trial of 1,350 older adults (50+ years) with either advanced cancer (defined as metastatic solid tumor) or end-stage organ failure (New York Heart Association (NYHA) Class III or IV Heart Failure, End Stage Renal Disease defined as GFR < 15 ml/min/m2; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher or oxygen-dependent chronic obstructive pulmonary disease (COPD) defined as FEV1 < 50% or the mMRC dyspnea scale) who present to the Emergency Department (ED), along with 675 of their informal caregivers. Investigators will compare the effectiveness of two distinct palliative care models: a) nurse-led telephonic case management; and b) facilitated, outpatient specialty palliative care.

Official Title
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Emergency Medicine Palliative Care Access (EMPallA)

Conditions
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Advanced Cancer, End Stage Organ Failure

Intervention / Treatment
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* Behavioral: Nurse-led telephonic case management
* Behavioral: Facilitated,outpatient specialty palliative care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: English or Spanish-speaking patients ages 50 years and older Qualifying serious, life-limiting conditions and who are scheduled for ED discharge, observation status, or admission for two midnights or less. Qualifying conditions include: advanced cancer (defined as metastatic solid tumor) or end-stage organ failure (New York Heart Association (NYHA) Class III or IV Heart Failure, End Stage Renal Disease defined as GFR < 15 ml/min/m2; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher or oxygen-dependent chronic obstructive pulmonary disease (COPD) defined as FEV1 < 50% or the mMRC dyspnea scale) Patients must have health insurance, reside within the geographical area, and have a working telephone. Informal Caregivers: English or Spanish-speaking caregivers ages 18 years and older who care for and accompany an enrolled patient. Informal caregivers must possess a working telephone. Exclusion Criteria: Patients with dementia identified in the EHR, who received hospice services in the last six months, who have received 2 or more palliative care visits in the last 6 months, and those who reside in a skilled nursing or assisted living facility and chronic care hospital.

Ages Eligible for Study
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Minimum Age: 50 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse-led telephonic case management<br>Telephonic nurses will contact patients within 72 hours of enrollment Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months. | Behavioral: Nurse-led telephonic case management<br>* Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.<br>|
| Active Comparator: Facilitated, outpatient specialty palliative care<br>Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months. Clinic visits will be scheduled the same day as other specialty appointments if possible | Behavioral: Facilitated,outpatient specialty palliative care<br>* In-person palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life for patients, as measured by the FACT-G | Measured by change from enrollment to 6 months | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Level: Healthcare Utilization, as measured by self-report and EHR abstraction | Measured by change from enrollment to 12 months (e.g., ED revisits, hospital admissions, hospice use) | 12 Months | 
| Loneliness, as measured by the Three-Item Loneliness Scale | Used to measure how often a person feels disconnected from others Three questions total 4-point rating scale (1 = never; 2 = rarely; 3 = sometimes; 4 = always). Reverse-code the positively worded items so that high values mean more loneliness, and then calculate a score for each respondent by averaging their ratings. | 6 Months | 
| Symptom burden, as measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) | Used to measure severity of symptoms 10 questions 0-10 scale (0= none to 10 worst possible) Total score | 6 Months | 
| Caregiver-Level: Quality of Life, as measured by the Patient-Reported Outcome Measurement Information System | Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and global mental health scale. Both scales had internal consistency scores of α=0.81 and α=0.86, respectively. Scored by reverse coding with a raw score totaling up to 20 | 6 Months | 
| Caregiver Bereavement, as measured by the Texas Inventory of Grief | Measured by 3 months post-patient death | 3 Months |