Trial of Mount Sinai Palliative Care at Home

• ClinicalTrials.gov Identifier: NCT03793803
• Recruitment Status: Enrolling by invitation
• First Posted: January 4, 2019
• Last Update Posted: January 6, 2021
• Sponsor: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Nathan Goldstein, Icahn School of Medicine at Mount Sinai

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Organ Failure	Behavioral: Home Palliative Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 825 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients and caregivers are randomized to receive care from the home-based palliative care team or will receive usual care from their primary physician
• Masking: Single (Outcomes Assessor)
• Masking Description: Single Blind Control - Outcomes assessor is blind to randomization arms
• Primary Purpose: Health Services Research
• Official Title: Clinical Trial of Home Palliative Care for Seriously Ill Adults
• Actual Study Start Date: January 2, 2019
• Estimated Primary Completion Date: January 3, 2022
• Estimated Study Completion Date: October 3, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. Integrated Palliative Outcomes Scale [ Time Frame: 6 months ]
   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.

Secondary Outcome Measures :

1. McGill quality of life-revised [ Time Frame: 6 months ]
   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.
2. Family Satisfaction with End-of-Life Care (FAMCARE-10) [ Time Frame: 6 months ]
   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
3. Number of Completion of Advance Directives [ Time Frame: 6 months ]
   Study team will examine the patient's chart for completion of advanced directives.
4. Number of Preference Consistent Care [ Time Frame: 6 months ]
   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).
5. Zarit Burden Inventory [ Time Frame: 6 months ]
   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. FAMCARE-10 [ Time Frame: 6 months ]
   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.
7. The Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 months ]
   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.
8. Number of inpatient admissions [ Time Frame: 6 months ]
   Number of inpatient admissions to measure healthcare utilization
9. Number of emergency department visits [ Time Frame: 6 months ]
   Number of emergency department visits to measure healthcare utilization
10. Number of outpatient appointments [ Time Frame: 6 months ]
    Number of outpatient appointments to measure healthcare utilization

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United States, New York

Mount Sinai Beth Israel

New York, New York, United States, 10003

Mount Sinai West

New York, New York, United States, 10019

Mount Sinai St Luke's

New York, New York, United States, 10025

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

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

More Information

• Responsible Party: Nathan Goldstein, Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03793803
• Other Study ID Numbers: GCO 15-2215
• First Posted: January 4, 2019
• Last Update Posted: January 6, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nathan Goldstein, Icahn School of Medicine at Mount Sinai:

Palliative Care; Home-Based Care