Palliative Care at Home for Dementia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2022-04-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial of Mount Sinai Palliative Care at Home

NCT03793803

Organ Failure

COMPLETED NA

Palliative Care for Patients With Dementia

NCT05749146

Dementia

RECRUITING NA

Triggered Palliative Care for Advanced Dementia

NCT02719938

Alzheimer Disease Dementia

COMPLETED NA

Educational Video to Improve Nursing Home Care in End-stage Dementia

NCT01774799

Advanced Dementia

COMPLETED NA

Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers

NCT04948866

Dementia Dementia, Vascular Dementia With Lewy Bodies +5 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patient - caregiver pairs

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Single blind control

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Home Palliative Care

Randomized to Intervention Arm

Group Type EXPERIMENTAL

Home Palliative Care

Intervention Type BEHAVIORAL

Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.

Control Arm

Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No