Palliative Care at Home for Dementia

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798327
• Other study ID #: GCO 17-02787
• Secondary ID: R56AG067045-01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: April 29, 2022

Study information

• Verified date: July 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Mount Sinai Beth Israel	New York	New York
United States	Mount Sinai St. Luke's	New York	New York
United States	Mount Sinai West	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Management at the End of Life for Dementia scale	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	Patient Quality of Life - Alzheimer's Disease scale	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
Secondary	Number of Complete of Advance Directives	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
Secondary	Preference Consistent Care	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
Secondary	Caregiver Zaria 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 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
Secondary	Caregiver 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.; Scale: FamCare; Likert scale, 0-3, higher is higher satisfaction	6 months
Secondary	Caregiver 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).; Scale: Patient Health Questionnaire - 9; Likert scale, 0-3, total possible = 0-27; higher is worse depression [Time Frame: 6 months]	6 months
Secondary	Number of hospital admissions	healthcare utilization	6 months
Secondary	Number of emergency department visits	healthcare utilization	6 months
Secondary	Number of outpatient appointments	healthcare utilization	6 months