Mount Sinai Palliative Care at Home for Dementia

Video-Assisted Palliative Care Intervention for Patients With Advanced Dementia at Home

Sponsors

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Source Icahn School of Medicine at Mount Sinai
Brief Summary

The proposed project is a randomized controlled trial of a new home-based palliative care program for adults with advanced dementia 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 6 months.

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.

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. Visits will combine a combination of video-teleconferencing technology and in person visits. 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, video-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.

Overall Status Enrolling by invitation
Start Date November 1, 2018
Completion Date October 3, 2022
Primary Completion Date January 3, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Symptom Management at the End of Life for Dementia scale 6 months
Secondary Outcome
Measure Time Frame
Patient Quality of Life - Alzheimer's Disease scale 6 months
Number of Complete of Advance Directives 6 months
Preference Consistent Care 6 months
Caregiver Zaria Burden Inventory 6 months
Caregiver FAMCARE-10 6 months
Caregiver PHQ-9 6 months
Number of hospital admissions 6 months
Number of emergency department visits 6 months
Number of outpatient appointments 6 months
Enrollment 100
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Home Palliative Care

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

Arm Group Label: Home Palliative Care

Eligibility

Criteria:

Inclusion Criteria:

- Presence of advanced dementia

- 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 or has a caregiver who can provide consent for the patient

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 consent or has no caregiver who can provide consent

Gender: All

Minimum Age: 65 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Nathan Goldstein, MD Study Director Icahn School of Medicine at Mount Sinai
Location
Facility:
Mount Sinai Beth Israel | New York, New York, 10003, United States
Mount Sinai West | New York, New York, 10019, United States
Mount Sinai St. Luke's | New York, New York, 10025, United States
Icahn School of Medicine at Mount Sinai | New York, New York, 10029, United States
Location Countries

United States

Verification Date

January 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Home Palliative Care

Type: Experimental

Description: Randomized to Intervention Arm

Label: Control Arm

Type: No Intervention

Description: Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Health Services Research

Masking: Single (Outcomes Assessor)

Masking Description: Single blind control

Source: ClinicalTrials.gov