Dementia
Conditions
Keywords
Palliative Care, Home-Based Care
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.
Interventions
BEHAVIORALHome 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.
Sponsors
National Institute on Aging (NIA)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Single blind control
Intervention model description
Patient - caregiver pairs
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) | Baseline, 3 months, 6 months | Number of Patients who completed the SM-EOLD Assessment 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Complete of Advance Directives | 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 | 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) |
| Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory | Baseline, 3 months, 6 months | Number of Caregivers who completed the Caregiver Zaria Burden Inventory 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 |
| Number of Patients Who Completed the McGill Quality of Life Assessment | Baseline, 3 months, 6 months | Number of Patients who completed the McGill Quality of Life Assessment McGill Quality of Life instrument is assessment in the domains of physical symptoms, emotional well-being, social interactions, and an overall global rating. Alzheimer's Disease Scale: Quality of Life - Likert scale, 13 items, each 1-4. Total scale from 13- 52. Higher values are more positive scores. |
| Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9) | Baseline, 3 months, 6 months | Number of Caregivers who completed the Patient Health Questionnaire (PHQ-9) 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 \[Time Frame: 6 months\] |
| Mean Change in Number of Hospital Admissions | Baseline and 6 months | Healthcare Utilization measured from the data warehouse as well as using the Resource Use Instrument (RUI) collected through interviews with patients. assessed by hospital admissions |
| Hospital Length of Stay | 6 months | Patient healthcare utilization as assessed by hospital length of stay over the past 6 months |
| Number of Caregivers Who Completed the FAMCARE-10 Assessment | Baseline, 3 months, 6 months | Number of Caregivers who completed the FAMCARE-10 Assessment 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Home Palliative Care - Patients 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. | 14 |
| Usual Care - Control Arm - Patients Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses. | 16 |
| Home Palliative Care - Caregivers Caregivers of patients cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician. | 14 |
| Usual Care - Caregivers Usual Care - Caregivers of patients will be cared for by the physician who treats their dementia and other illnesses. | 16 |
| Total | 60 |
Baseline characteristics
| Characteristic | Home Palliative Care - Caregivers | Usual Care - Caregivers | Total | Home Palliative Care - Patients | Usual Care - Control Arm - Patients |
|---|---|---|---|---|---|
| Age, Continuous Caregivers | 59.2 years STANDARD_DEVIATION 0.85 | 58.0 years STANDARD_DEVIATION 0.85 | 58.6 years STANDARD_DEVIATION 14.3 | — | — |
| Age, Continuous Patients | — | — | 82.7 years STANDARD_DEVIATION 1.1 | 81.9 years STANDARD_DEVIATION 0.75 | 83.4 years STANDARD_DEVIATION 0.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 13 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 9 Participants | 34 Participants | 7 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 13 Participants | 5 Participants | 1 Participants |
| Highest Education obtained High school diploma/GED or greater | 5 Participants | 6 Participants | 25 Participants | 6 Participants | 8 Participants |
| Highest Education obtained Less than high school diploma/GED | 0 Participants | 0 Participants | 6 Participants | 2 Participants | 4 Participants |
| Highest Education obtained Missing | 9 Participants | 10 Participants | 29 Participants | 6 Participants | 4 Participants |
| Marital Status Divorced | 1 Participants | 1 Participants | 2 Participants | — | — |
| Marital Status Married | 6 Participants | 7 Participants | 13 Participants | — | — |
| Marital Status Missing | 6 Participants | 5 Participants | 11 Participants | — | — |
| Marital Status Single | 1 Participants | 3 Participants | 4 Participants | — | — |
| Number of Participants who lives alone | 0 Participants | 1 Participants | 7 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 4 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 7 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 8 Participants | 19 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 30 Participants | 9 Participants | 9 Participants |
| Sex/Gender, Customized Female | 11 Participants | 11 Participants | 44 Participants | 10 Participants | 12 Participants |
| Sex/Gender, Customized Male | 1 Participants | 3 Participants | 12 Participants | 4 Participants | 4 Participants |
| Sex/Gender, Customized Missing | 2 Participants | 2 Participants | 4 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD)
Number of Patients who completed the SM-EOLD Assessment 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
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home Palliative Care - Patients | Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) | Baseline Admission | 14 Participants |
| Home Palliative Care - Patients | Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) | 3 months | 6 Participants |
| Home Palliative Care - Patients | Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) | 6 months | 2 Participants |
| Usual Care - Control Arm - Patients | Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) | Baseline Admission | 16 Participants |
| Usual Care - Control Arm - Patients | Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) | 3 months | 5 Participants |
| Usual Care - Control Arm - Patients | Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) | 6 months | 7 Participants |
Secondary
Hospital Length of Stay
Patient healthcare utilization as assessed by hospital length of stay over the past 6 months
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Palliative Care - Patients | Hospital Length of Stay | 0 days | Standard Deviation 1.7 |
| Usual Care - Control Arm - Patients | Hospital Length of Stay | 1.3 days | Standard Deviation 2.9 |
Secondary
Mean Change in Number of Hospital Admissions
Healthcare Utilization measured from the data warehouse as well as using the Resource Use Instrument (RUI) collected through interviews with patients. assessed by hospital admissions
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Palliative Care - Patients | Mean Change in Number of Hospital Admissions | 0 admissions | Standard Deviation 0.6 |
| Usual Care - Control Arm - Patients | Mean Change in Number of Hospital Admissions | 0.5 admissions | Standard Deviation 0.7 |
Secondary
Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory
Number of Caregivers who completed the Caregiver Zaria Burden Inventory 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
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home Palliative Care - Patients | Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory | Baseline - admissions | 13 Participants |
| Home Palliative Care - Patients | Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory | 3 months | 6 Participants |
| Home Palliative Care - Patients | Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory | 6 months | 2 Participants |
| Usual Care - Control Arm - Patients | Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory | Baseline - admissions | 13 Participants |
| Usual Care - Control Arm - Patients | Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory | 3 months | 3 Participants |
| Usual Care - Control Arm - Patients | Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory | 6 months | 5 Participants |
Secondary
Number of Caregivers Who Completed the FAMCARE-10 Assessment
Number of Caregivers who completed the FAMCARE-10 Assessment 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
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home Palliative Care - Patients | Number of Caregivers Who Completed the FAMCARE-10 Assessment | Baseline - Admissions | 13 Participants |
| Home Palliative Care - Patients | Number of Caregivers Who Completed the FAMCARE-10 Assessment | 3 months | 6 Participants |
| Home Palliative Care - Patients | Number of Caregivers Who Completed the FAMCARE-10 Assessment | 6 months | 2 Participants |
| Usual Care - Control Arm - Patients | Number of Caregivers Who Completed the FAMCARE-10 Assessment | Baseline - Admissions | 13 Participants |
| Usual Care - Control Arm - Patients | Number of Caregivers Who Completed the FAMCARE-10 Assessment | 3 months | 3 Participants |
| Usual Care - Control Arm - Patients | Number of Caregivers Who Completed the FAMCARE-10 Assessment | 6 months | 5 Participants |
Secondary
Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9)
Number of Caregivers who completed the Patient Health Questionnaire (PHQ-9) 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 \[Time Frame: 6 months\]
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home Palliative Care - Patients | Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9) | Baseline - Admissions | 13 Participants |
| Home Palliative Care - Patients | Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9) | 3 months | 6 Participants |
| Home Palliative Care - Patients | Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9) | 6 months | 2 Participants |
| Usual Care - Control Arm - Patients | Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9) | Baseline - Admissions | 14 Participants |
| Usual Care - Control Arm - Patients | Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9) | 3 months | 3 Participants |
| Usual Care - Control Arm - Patients | Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9) | 6 months | 5 Participants |
Secondary
Number of Complete of Advance Directives
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).
Time frame: 6 months
Secondary
Number of Patients Who Completed the McGill Quality of Life Assessment
Number of Patients who completed the McGill Quality of Life Assessment McGill Quality of Life instrument is assessment in the domains of physical symptoms, emotional well-being, social interactions, and an overall global rating. Alzheimer's Disease Scale: Quality of Life - Likert scale, 13 items, each 1-4. Total scale from 13- 52. Higher values are more positive scores.
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home Palliative Care - Patients | Number of Patients Who Completed the McGill Quality of Life Assessment | Baseline - Admission | 14 Participants |
| Home Palliative Care - Patients | Number of Patients Who Completed the McGill Quality of Life Assessment | 3 months | 6 Participants |
| Home Palliative Care - Patients | Number of Patients Who Completed the McGill Quality of Life Assessment | 6 months | 2 Participants |
| Usual Care - Control Arm - Patients | Number of Patients Who Completed the McGill Quality of Life Assessment | Baseline - Admission | 15 Participants |
| Usual Care - Control Arm - Patients | Number of Patients Who Completed the McGill Quality of Life Assessment | 3 months | 5 Participants |
| Usual Care - Control Arm - Patients | Number of Patients Who Completed the McGill Quality of Life Assessment | 6 months | 7 Participants |
Secondary
Preference Consistent Care
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)
Time frame: 6 months