Trial of Mount Sinai Palliative Care at Home

NCT ID: NCT03793803

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-11-01

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.

Conditions

Organ Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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 primary illness(es).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Nathan Goldstein

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathan Goldstein, MD

Role: STUDY_DIRECTOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Beth Israel

New York, New York, United States

Mount Sinai West

New York, New York, United States

Mount Sinai St Luke's

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 15-2215

Identifier Type: -

Identifier Source: org_study_id