Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05749146
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-02-18
Brief Title:
Palliative Care for Patients with Dementia
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Palliative Care At Home for Patients with Dementia and Their Caregivers
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multi-site single-blinded parallel randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers From inpatient and outpatient settings associated with four hospitals across New York City patients with advanced dementia and their family caregivers will be randomized to intervention or augmented control
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 teams registered nurse andor 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 andor 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
Patients randomized to the intervention will be scheduled for an intake visit This visit will be undertaken by the teams registered nurse andor 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG067045 | NIH | None | httpsreporternihgovquickSearchR01AG067045 |