Jumpstarting Advance Care Planning With ANAI People

NCT ID: NCT06538493

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advance Care Planning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Jumpstart 1

Questionnaire on advance care planning experiences, preferences, and concerns

Group Type EXPERIMENTAL

JUMPSTART-ANAI

Intervention Type BEHAVIORAL

Patient questionnaire about experiences, preferences, and concerns regarding ACP followed by feedback form with "tips" for initiating ACP conversation with provider at next clinical visit.

Jumpstart 2

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

Group Type ACTIVE_COMPARATOR

JUMPSTART-ANAI

Intervention Type BEHAVIORAL

Patient questionnaire about experiences, preferences, and concerns regarding ACP followed by feedback form with "tips" for initiating ACP conversation with provider at next clinical visit.

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

JUMPSTART-ANAI

Patient questionnaire about experiences, preferences, and concerns regarding ACP followed by feedback form with "tips" for initiating ACP conversation with provider at next clinical visit.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Alaska Native and/or American Indian
* Age 40 or older
* Empaneled to a Southcentral Foundation primary care provider
* Diagnosed with at least 1 serious illness (e.g., cancer, COPD, kidney disease)
* Has made 2 or more to primary care in last 12 months
* No Advance Directive documented in electronic health record

Exclusion Criteria

* Cognitive impairment (≥ 2 errors) as assessed by the validated Short Portable Mental Status Questionnaire
* Not able to complete 30-minute study visit by phone or in person
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Arkansas

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

Alaska Native Tribal Health Consortium

OTHER

Sponsor Role collaborator

University of Alaska Fairbanks

OTHER

Sponsor Role collaborator

Southcentral Foundation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jennifer Shaw

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jennifer Shaw, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alaska Fairbanks

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Southcentral Foundation

Anchorage, Alaska, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shannon Medlock

Role: CONTACT

(907)729-6322

John Trainor, PhD, MPH

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Richard B Woodbury, MPH

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5R01NR020491

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Improving Cardiac Secondary Prevention
NCT03269708 ACTIVE_NOT_RECRUITING NA
ENCOMPASS: Expansion Study C
NCT04791267 COMPLETED NA
iControl Chronic Kidney Disease
NCT03951363 TERMINATED NA
ActionHealthNYC Research Study
NCT02841930 ACTIVE_NOT_RECRUITING NA
ENCOMPASS: Expansion Study A, RCT
NCT04790604 COMPLETED NA