Palliative Care for Patients With Dementia

Dementia Clinical Trial

Official title:

Palliative Care at Home for Patients With Dementia and Their Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749146
• Other study ID #: GCO 19-1232
• Secondary ID: R01AG067045
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Christian Espino
• Phone: (212) 421-4632
• Email: Christian.Espino[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multi-site, single-blinded, parallel, randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers. From inpatient and outpatient settings associated with four hospitals across New York City, patients with advanced dementia and their family caregivers will be randomized to intervention or augmented control.

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: Recruiting
• Enrollment: 300
• Est. completion date: April 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• have advanced dementia, based on Global Deterioration Score (GDS)>6

• impairment in at least one activity of daily living (ADL -which is inherent in this level of GDS)

• at least one hospitalization or ED visit within the last 12 months

• a physician who is primarily responsible for their dementia-related care whose clinical outpatient site is associated with one of the four Mount Sinai sites in Manhattan

• a family caregiver willing to enroll

• a residence in Manhattan where they are currently living (not in a long-term care facility)

• capacity to consent or a legal representative available to provide consent

• fluency in English or Spanish, or their legal representative must be fluent in English or Spanish

• age >64.

Exclusion Criteria:

• Does not have a family caregiver to enroll

• Does not reside in Manhattan outside of long-term care facility

• Does not have fluency in English or Spanish Doesn't

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	Ichan School of Medicine at Mount Sinai	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 as measured by 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. The Symptom Management at the End of Life in Dementia (SM-EOLD) scale responses range from 0 to 45 with higher scores indicating better symptom management.	6 months
Secondary	Number of Hospital Admissions	Acute care utilization as measured by the number of hospital admissions	at 12 months
Secondary	Number of Hospital Stays	Acute care utilization as measured by the number of hospital days	at 12 months
Secondary	Patient reported treatment concordance	The Study Team will examine if the care patients receive is concordant with the care they wanted to receive using simple chart review of whether care received matches stated preferences (yes/no).	at 12 months
Secondary	Cost Analysis	Total costs between the arms including inpatient, emergency department, ambulatory services, and home care services will be compared. Costs of the clinical intervention (e.g. clinical personnel, transportation) will be included in the analyses.	at 12 months
Secondary	Caregiver burden per Zarit 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). Full scale from 22 - 110, higher score indicates a greater burden.	at 6 months
Secondary	Caregiver burden per Zarit 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). Full scale from 22 - 110, higher score indicates a greater burden.	at 12 months
Secondary	Caregiver satisfaction measured using 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. Full scale ranges 0-20, with higher scores indicating higher satisfaction.	at 6 months
Secondary	Caregiver satisfaction measured using 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. Full scale ranges 0-20, with higher scores indicating higher satisfaction.	at 12 months
Secondary	Caregiver depression measured by PHQ-9 Score	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 more severe symptoms.	at 6 months
Secondary	Caregiver depression measured by PHQ-9 Score	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 more severe symptoms.	at 12 months