Trial of Mount Sinai Palliative Care at Home

Clinical Trial of Home Palliative Care for Seriously Ill Adults

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.

Study Overview

• Status: Completed
• Conditions: Organ Failure
• Intervention / Treatment: Behavioral: Home Palliative Care

Detailed Description

The objective of this randomized controlled trial is to study the impact of a new home based palliative care program on patients' symptoms, quality of life, satisfaction with care, completion of advance care planning documentation and receipt of care consistent with preferences. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver burden and prevalence of depression.

Patients randomized to the intervention will be scheduled for an intake visit. This visit will be undertaken by the team's registered nurse and/or social worker, together with a community health worker, and other team members (advanced practice nurse, MD), depending on patients' needs. Following this visit, and in conjunction with the nurse practitioner and/or MD, a care plan will be developed to address areas of clinical need highlighted during the intake visit.

Patients in the intervention arm will receive ongoing monitoring and input (telephone-based and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10019
      • Mount Sinai West
    • New York, New York, United States, 10025
      • Mount Sinai St Luke's
    • New York, New York, United States, 10003
      • Mount Sinai Beth Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Palliative Care; Randomized to Intervention Arm	Behavioral: Home Palliative Care; Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
No Intervention: Control Arm; Usual Care - Patients will be cared for by the physician who treats their primary illness(es).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
McGill quality of life-revised	McGill quality of life-revised is a 14 item instrument administered to patient-subjects via telephone interview or in person by the trained research coordinator. Each item score on likert scale from 0-10, full scale from 0-140 with higher score indicating better quality of life.	6 months
Family Satisfaction with End-of-Life Care (FAMCARE-10)	FAMCARE-10 to assess patient satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. FamCare each item score on likert scale 0-3, total scale from 0-30, with higher score indicating higher satisfaction	6 months
Number of Completion of Advance Directives	Study team will examine the patient's chart for completion of advanced directives.	6 months
Number of Preference Consistent Care	Study team will examine if the care patients receive is concordant with the care they wanted to receive. simple chart review of whether care received matches stated preferences (yes/no).	6 months
Zarit Burden Inventory	Zarit Burden Inventory to determine caregiver burden by using a validated structured 22-item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. Each item is on a 5-point score range from 0 (never) to 4 (always). Full scale from 0 to 88, with higher score indicating more burden.	6 months
FAMCARE-10	FAMCARE-10 to assess caregiver satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. FamCare each item score on likert scale 0-3, total scale from 0-30, with higher score indicating higher satisfaction.	6 months
The Patient Health Questionnaire (PHQ-9)	PHQ-9 to assess Caregiver Depression by using a validated structured 9 item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Full scale from 0-27, with higher score indicating worse depression.	6 months
Number of inpatient admissions	Number of inpatient admissions to measure healthcare utilization	6 months
Number of emergency department visits	Number of emergency department visits to measure healthcare utilization	6 months
Number of outpatient appointments	Number of outpatient appointments to measure healthcare utilization	6 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Study Director: Nathan Goldstein, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: December 24, 2018
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Palliative Care; Home-Based Care
• Other Study ID Numbers: GCO 15-2215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No