Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-05 @ 1:05 AM
Study NCT ID:
NCT06538493
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2024-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Jumpstarting Advance Care Planning With ANAI People
Sponsor:
Southcentral Foundation
Organization:
Study Overview
Official Title:
Jumpstarting Culturally-informed Advance Care Planning With ANAI People in Primary Care
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:
The older Alaska Native/American Indian (ANAI) population is increasing at twice the rate of the general population with a higher burden of serious illness. Older ANAI adults with serious illness are half as likely to have advance directives (AD), indicating a need for improved access to and utilization of advance care planning (ACP) to ensure that medical care aligns with the values, goals, and preferences of ANAI patients and their families throughout the illness trajectory. The major goals of this cluster randomized trial (CRT) are to (1) evaluate the comparative effectiveness of usual care and JUMPSTART- ANAI, a culturally tailored ACP communication intervention, for prompting patient-driven ACP conversations between ANAI adults and primary care providers and to (1) identify key factors to successfully implement the intervention in health systems serving ANAI adults with serious illness.
Detailed Description:
Despite a disproportionate burden of serious illness, Alaska Native and American Indian (ANAI) people are far less likely than their peers in the general US population to use palliative care, including advance care planning (ACP), which aims to align medical care with patients' values, goals, and preferences. ACP has been demonstrated to result in decreased depression, anxiety, and grief for patients and their families, increased symptom management, and fewer non-beneficial and unwanted end-of-life treatments. ACP is typically documented in advance directives (ADs) that specify patient preferences for life-sustaining treatments and who can make medical decisions on their behalf. Yet, ANAI people ages 55 and older are half as likely to have ADs as their White peers. A previous study culturally tailored and piloted an ACP communication intervention-JUMPSTART-ANAI-among 68 ANAI adults with serious illness in a Tribal health system in Alaska. This project builds on the previous study with a type 1 hybrid effectiveness-implementation trial of JUMPSTART-ANAI. The goal of this study is tailor an implementation plan for JUMPSTART-ANAI, evaluate the comparative effectiveness of the intervention and usual care for promoting patient-driven ACP communication, as measured by ADs documented in the electronic health record and identify key factors for successfully implementing JUMPSTART-ANAI in primary care systems serving ANAI adults with serious illness. Increasing access to culturally appropriate, evidence-based ACP is a high priority for Alaska Native health leaders and communities. By evaluating the effectiveness of a culturally tailored ACP intervention and tailoring implementation of the intervention for use in routine primary care, this study will generate critical information for implementing and improving palliative care services among a rapidly growing population of ANAI adults with serious illness.
Study Oversight
Has Oversight DMC:
True
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?: