Clinical trial NCT05749146: Palliative Care for Patients with Dementia
Official title: Palliative Care At Home for Patients with Dementia and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-03-01
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects assigned to intervention or control arms in a 1:1 ratio
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom Management as measured by the End of Life for Dementia scale
timeFrame: 6 months
Secondary outcomes:
measure: Number of Hospital Admissions
timeFrame: at 12 months
measure: Number of Hospital Stays
timeFrame: at 12 months
measure: Patient reported treatment concordance
timeFrame: at 12 months
measure: Cost Analysis
timeFrame: at 12 months
measure: Caregiver burden per Zarit Burden Inventory
timeFrame: at 6 months
measure: Caregiver burden per Zarit Burden Inventory
timeFrame: at 12 months
measure: Caregiver satisfaction measured using FAMCARE-10
timeFrame: at 6 months
measure: Caregiver satisfaction measured using FAMCARE-10
timeFrame: at 12 months
measure: Caregiver depression measured by PHQ-9 Score
timeFrame: at 6 months
measure: Caregiver depression measured by PHQ-9 Score
timeFrame: at 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Ichan School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Laura P Gelfman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: