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Mount Sinai Palliative Care at Home for Dementia

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ClinicalTrials.gov Identifier: NCT03798327
Recruitment Status : Enrolling by invitation
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.


Condition or disease Intervention/treatment Phase
Dementia Behavioral: Home Palliative Care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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


  2. 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).


  3. 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)


  4. 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


  5. 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


  6. 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]


  7. Number of hospital admissions [ Time Frame: 6 months ]
    healthcare utilization

  8. Number of emergency department visits [ Time Frame: 6 months ]
    healthcare utilization

  9. Number of outpatient appointments [ Time Frame: 6 months ]
    healthcare utilization



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798327


Locations
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
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Study Director: Nathan Goldstein, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03798327     History of Changes
Other Study ID Numbers: GCO 17-02787
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
Palliative Care
Home-Based Care

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders