跳至主要内容
临床试验/NCT06538493
NCT06538493招募中不适用

Jumpstarting Advance Care Planning With ANAI People in Primary Care

Southcentral Foundation2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
2
主要终点
Number of Participants with an Advance Directive in the Electronic Health Record (EHR)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40 or older with a qualifying serious illness condition (e.g., COPD) OR Age 65 or older (regardless of diagnosis) AND Alaska Native and/or American Indian AND Empaneled to a primary care provider AND 2 or more to primary care in last 12 months AND No advance directives documented in electronic health record

排除标准

  • Unable to provide informed consent AND/OR Not able to complete 30-minute study visit by phone, video call, or in person

研究组 & 干预措施

Usual care

No Intervention

Jumpstart 1

Experimental

Questionnaire on advance care planning experiences, preferences, and concerns

干预措施: JUMPSTART-ANAI (Behavioral)

Jumpstart 2

Active Comparator

Questionnaire on advance care planning experiences, preferences, and concerns plus feedback form (patient and provider)

干预措施: JUMPSTART-ANAI (Behavioral)

结局指标

主要结局

Number of Participants with an Advance Directive in the Electronic Health Record (EHR)

时间窗: Baseline, 3 months, 6 months, 12 months

New advance directive scanned into EHR

Advance directives

时间窗: Baseline, 3 months, 6 months, 12 months

Advance directives documented in patient electronic health record

Number of participants with an advance directive in the electronic health record

时间窗: Baseline, 3 months, 6 months, 12 months

New advance directive scanned into EHR

次要结局

  • Quality of communication(Baseline, 3 months)
  • Psychological distress(Baseline, 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Shaw

Principal Investigator

University of Alaska Fairbanks

研究点 (2)

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