Trial of Mount Sinai Palliative Care at Home

NCT03793803 | Completed

• 1 other identifier: GCO 15-2215
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 4

Brief Summary

The proposed project is a randomized controlled trial of a new home-based palliative care program for adults with serious illness and their caregivers within the Mount Sinai Health System. Potential subjects will be identified from Mount Sinai records or referred by a Mount Sinai healthcare provider. Patients will only be approached after authorization by their Mount Sinai physician. Participants who consent to enrollment will be randomized to receive the intervention (home-based palliative care program) or usual care (with their nominated Mount Sinai physician). Patients will be enrolled in the study for a minimum of 6 months. After 6 months, patients can remain in the program if there is ongoing clinical need; data collection beyond 6 months will be done on all patients through chart abstraction/ administrative claims only. Effectiveness of the intervention will be determined through assessment of patient and caregiver reported outcomes and abstraction of data from medical records and administrative claims. Impact on the following parameters will be measured: (i) Patient symptoms, quality of life, satisfaction with care, documentation of advanced directives, receipt of care consistent with preferences (ii) Caregiver burden, satisfaction with care, and depression (iii) Healthcare utilization and costs of care.

Conditions

Organ Failure

Keywords

Palliative Care; Home-Based Care

Outcome Measures

Primary Outcomes (1)

• Integrated Palliative Outcomes Scale

  Patient symptoms determined by the Integrated Palliative Outcomes Scale, a validated structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. The Integrated Palliative Outcomes Scale is scored on a likert scale from 0-4, with higher score indicating worse symptoms.

  6 months

Secondary Outcomes (10)

• McGill quality of life-revised

  6 months

• Family Satisfaction with End-of-Life Care (FAMCARE-10)

  6 months

• Number of Completion of Advance Directives

  6 months

• Number of Preference Consistent Care

  6 months

• Zarit Burden Inventory

  6 months

Study Arms (2)

Home Palliative Care

EXPERIMENTAL

Randomized to Intervention Arm

Behavioral: Home Palliative Care

Control Arm

NO INTERVENTION

Usual Care - Patients will be cared for by the physician who treats their primary illness(es).

Interventions

Home Palliative Care BEHAVIORAL

Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.

Home Palliative Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of a "serious medical illness" - according to pre-specified diagnostic code-based criteria
• Subject has a Mount Sinai physician who authorizes their participation in the study and receipt of the program
• Subject is resident in Manhattan outside of a long term care facility and is not receiving hospice 5.
• Subject has evidence of capacity to benefit from enrollment in palliative care program
• Subject is conversant in English or Spanish
• Subject has capacity to consent

You may not qualify if:

• Subject has no usual physician within Mount Sinai
• Subject's usual physician doesn't provide authorization to patient participation
• Subject resident outside of Manhattan or in long term care facility or receiving hospice
• Subject is not conversant in English or Spanish
• Subject cannot provide informed consent to participation
• Dementia (where the subject does not have the capacity to consent)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (4)

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

Mount Sinai St Luke's

New York, New York, 10025, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

• Nathan Goldstein, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind Control - Outcomes assessor is blind to randomization arms
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients and caregivers are randomized to receive care from the home-based palliative care team or will receive usual care from their primary physician

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: January 4, 2019
• Study Start: October 1, 2018
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)