Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629142
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Comparing Optimized Models of Primary And Specialist Services for Palliative Care Pilot Feasibility Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparing Optimized Models of Primary And Specialist Services for Palliative Care Pilot Feasibility Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Palliative care PC seeks to reduce suffering and improve quality of life for patients with serious illnesses and their families National guidelines recommend that clinicians either provide palliative care themselves generalist PC or consult experts specialist PC as a standard part of serious illness care This feasibility pilot study will be conducted with 6 hospitals at two large US health systems and enroll 540 seriously ill hospitalized patients Eligibility is determined by a mortality prediction score where enrolled patients have at least a 60 risk of dying within 1 year Enrollment assessment occurs as close as possible to 36 hours post admission In this cluster-randomized trial the 6 hospitals will be randomized to 3 arms 1 standardized usual care 2 trained generalist PC or 3 specialist PC Generalists are trained using the Center to Advance Palliative Care CAPC online trainings The pilot study will only measure process outcomes to assess the feasibility of a larger clinical trial eg are the interventions working as intended This pilot feasibility study is the precursor to a much larger pragmatic hybrid effectiveness-implementation parallel-cluster RCT that will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None