Clinical trial NCT03793803: Trial of Mount Sinai Palliative Care at Home
Official title: Clinical Trial of Home Palliative Care for Seriously Ill Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Failure
Keywords: Palliative Care
Home-Based Care
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 193
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients and caregivers are randomized to receive care from the home-based palliative care team or will receive usual care from their primary physician
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 serious illness 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 a minimum of 6 months.

After 6 months, patients can remain in the program if there is ongoing clinical need; data collection beyond 6 months will be done on all patients through chart abstraction/ administrative claims only.

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. 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 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 a "serious medical illness" - according to pre-specified diagnostic code-based criteria
* 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

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 informed consent to participation
* Dementia (where the subject does not have the capacity to consent)

Primary outcomes:
measure: Integrated Palliative Outcomes Scale
timeFrame: 6 months
Secondary outcomes:
measure: McGill quality of life-revised
timeFrame: 6 months
measure: Family Satisfaction with End-of-Life Care (FAMCARE-10)
timeFrame: 6 months
measure: Number of Completion of Advance Directives
timeFrame: 6 months
measure: Number of Preference Consistent Care
timeFrame: 6 months
measure: Zarit Burden Inventory
timeFrame: 6 months
measure: FAMCARE-10
timeFrame: 6 months
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
measure: Number of inpatient admissions
timeFrame: 6 months
measure: Number of emergency department visits
timeFrame: 6 months
measure: Number of outpatient appointments
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: