Palliative Care at Home for Dementia

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Behavioral: Home Palliative Care

• Registration Number: NCT03798327
• Lead Sponsor: 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-09
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Palliative Care	Home Palliative Care	Randomized to Intervention Arm

Primary Outcome Measures

Name	Time	Method
Symptom Management at the End of Life for Dementia scale	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

Secondary Outcome Measures

Name	Time	Method
Number of Complete of Advance Directives	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).
Caregiver Zaria Burden Inventory	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
Caregiver FAMCARE-10	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
Number of emergency department visits	6 months	healthcare utilization
Preference Consistent Care	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)
Caregiver PHQ-9	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 \[Time Frame: 6 months\]
Patient Quality of Life - Alzheimer's Disease scale	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
Number of hospital admissions	6 months	healthcare utilization
Number of outpatient appointments	6 months	healthcare utilization

Trial Locations

Locations (4)

Mount Sinai West; 🇺🇸 New York, New York, United States

Mount Sinai St. Luke's; 🇺🇸 New York, New York, United States

Mount Sinai Beth Israel; 🇺🇸 New York, New York, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States