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Emergency Medicine Palliative Care Access (EMPallA)

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ClinicalTrials.gov Identifier: NCT03325985
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : February 8, 2021
Sponsor:
Collaborators:
William Beaumont Hospitals
Brigham and Women's Hospital
Ohio State University
University of Florida Health
Yale New Haven Health System Center for Healthcare Solutions
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE October 26, 2017
First Posted Date  ICMJE October 30, 2017
Last Update Posted Date February 8, 2021
Actual Study Start Date  ICMJE March 28, 2018
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
Change in quality of life for patients, as measured by the FACT-G [ Time Frame: 6 Months ]
Measured by change from enrollment to 6 months
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2017)
Change in quality of life for patients, as measured by FACT-G [ Time Frame: Enrollment to 6 Months ]
Comparison of both interventions on quality of life in patients
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Patient Level: Healthcare Utilization, as measured by self-report and EHR abstraction [ Time Frame: 12 Months ]
    Measured by change from enrollment to 12 months (e.g., ED revisits, hospital admissions, hospice use)
  • Loneliness, as measured by the Three-Item Loneliness Scale [ Time Frame: 6 Months ]
    • 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.
  • Symptom burden, as measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) [ Time Frame: 6 Months ]
    • Used to measure severity of symptoms
    • 10 questions
    • 0-10 scale (0= none to 10 worst possible)
    • Total score
  • Caregiver-Level: Quality of Life, as measured by the Patient-Reported Outcome Measurement Information System [ Time Frame: 6 Months ]
    • 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
  • Caregiver Bereavement, as measured by the Texas Inventory of Grief [ Time Frame: 3 Months ]
    Measured by 3 months post-patient death
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emergency Medicine Palliative Care Access
Official Title  ICMJE Emergency Medicine Palliative Care Access (EMPallA)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Estimated Enrollment (1350 patients, 675 caregivers)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Advanced Cancer
  • End Stage Organ Failure
Intervention  ICMJE
  • Behavioral: Nurse-led telephonic case management
    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.
  • Behavioral: Facilitated,outpatient specialty palliative care
    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.
Study Arms  ICMJE
  • Experimental: Nurse-led telephonic case management
    • 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.
    Intervention: Behavioral: Nurse-led telephonic case management
  • Active Comparator: Facilitated, outpatient specialty palliative care
    • 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
    Intervention: Behavioral: Facilitated,outpatient specialty palliative care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2017)
2025
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2022
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Corita Grudzen, MD 646-501-0565 Corita.Grudzen@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03325985
Other Study ID Numbers  ICMJE 17-01211
R-1609-36306 ( Other Grant/Funding Number: PCORI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE
  • William Beaumont Hospitals
  • Brigham and Women's Hospital
  • Ohio State University
  • University of Florida Health
  • Yale New Haven Health System Center for Healthcare Solutions
  • Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Corita Grudzen, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP