Clinical trial NCT03798327: Palliative Care at Home for Dementia
Official title: Video-Assisted Palliative Care Intervention for Patients With Advanced Dementia at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Palliative Care
Home-Based Care
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient - caregiver pairs
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD)
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Number of Patients Who Completed the McGill Quality of Life Assessment
timeFrame: Baseline, 3 months, 6 months
measure: Number of Complete of Advance Directives
timeFrame: 6 months
measure: Preference Consistent Care
timeFrame: 6 months
measure: Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory
timeFrame: Baseline, 3 months, 6 months
measure: Number of Caregivers Who Completed the FAMCARE-10 Assessment
timeFrame: Baseline, 3 months, 6 months
measure: Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 3 months, 6 months
measure: Mean Change in Number of Hospital Admissions
timeFrame: Baseline and 6 months
measure: Hospital Length of Stay
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: New York
country: United States
facility: Mount Sinai St. Luke's
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nathan Goldstein, MD
role: STUDY_DIRECTOR
References:
citation: Estrada LV, Gelfman L, Zhang M, Espino C, Goldstein N. Challenges and solutions of conducting dementia clinical trials: A palliative care at home pilot for persons with dementia. J Am Geriatr Soc. 2024 Aug;72(8):2544-2551. doi: 10.1111/jgs.18966. Epub 2024 May 22.