Mount Sinai Palliative Care at Home for Dementia
|ClinicalTrials.gov Identifier: NCT03798327|
Recruitment Status : Enrolling by invitation
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Behavioral: Home Palliative Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Single blind control|
|Primary Purpose:||Health Services Research|
|Official Title:||Video-Assisted Palliative Care Intervention for Patients With Advanced Dementia at Home|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||January 3, 2022|
|Estimated Study Completion Date :||October 3, 2022|
Experimental: Home Palliative Care
Randomized to Intervention Arm
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.
No Intervention: Control Arm
Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses.
- Symptom Management at the End of Life for Dementia scale [ Time Frame: 6 months ]
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
- Patient Quality of Life - Alzheimer's Disease scale [ Time Frame: 6 months ]
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
- Number of Complete of Advance Directives [ Time Frame: 6 months ]
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).
- Preference Consistent Care [ Time Frame: 6 months ]
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)
- Caregiver Zaria Burden Inventory [ Time Frame: 6 months ]
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
- Caregiver FAMCARE-10 [ Time Frame: 6 months ]
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
- Caregiver PHQ-9 [ Time Frame: 6 months ]
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]
- Number of hospital admissions [ Time Frame: 6 months ]healthcare utilization
- Number of emergency department visits [ Time Frame: 6 months ]healthcare utilization
- Number of outpatient appointments [ Time Frame: 6 months ]healthcare utilization
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798327
|United States, New York|
|Mount Sinai Beth Israel|
|New York, New York, United States, 10003|
|Mount Sinai West|
|New York, New York, United States, 10019|
|Mount Sinai St. Luke's|
|New York, New York, United States, 10025|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Study Director:||Nathan Goldstein, MD||Icahn School of Medicine at Mount Sinai|