Palliative Care at Home for Dementia

July 28, 2022 updated by: Nathan Goldstein, Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 dementia and other illnesses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Management at the End of Life for Dementia scale
Time Frame: 6 months

This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator

Scale: Symptom Management at the End of Life for Dementia - Likert scale, 9 items, each 0-5, (45 total possible score) higher is worse symptoms
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Quality of Life - Alzheimer's Disease scale
Time Frame: 6 months

This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator.

Scale: Quality of Life - Alzheimer's Disease; Likert scale, 13 items, each 1-4, (52 total possible score) lower is worse quality of life
6 months
Number of Complete of Advance Directives
Time Frame: 6 months

The Study Team will examine the patient's chart for completion of advanced directives

Scale: Study Team will examine the patient's chart for completion of advanced directives (yes/no).
6 months
Preference Consistent Care
Time Frame: 6 months

The Study Team will examine if the care patients receive is concordant with the care they wanted to receive.

Scale: Simple chart review of whether care received matches stated preferences (yes/no)
6 months
Caregiver Zaria 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 scale range from 0 (never) to 4 (always)

Scale: Zarit Burden Inventory - Likert scale 0-4,total score = 0-88, higher score is more burden
6 months
Caregiver 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.

Scale: FamCare; Likert scale, 0-3, higher is higher satisfaction
6 months
Caregiver 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).

Scale: Patient Health Questionnaire - 9; Likert scale, 0-3, total possible = 0-27; higher is worse depression [Time Frame: 6 months]
6 months
Number of hospital admissions
Time Frame: 6 months
healthcare utilization
6 months
Number of emergency department visits
Time Frame: 6 months
healthcare utilization
6 months
Number of outpatient appointments
Time Frame: 6 months
healthcare utilization
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute on Aging (NIA)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

April 29, 2022

Study Completion (Actual)

April 29, 2022

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 8, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 17-02787
  • R56AG067045-01 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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