NCT06538493

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Apr 2025May 2027

First Submitted

Initial submission to the registry

August 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

July 1, 2025

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

August 1, 2024

Last Update Submit

June 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    New advance directive scanned into EHR

    Baseline, 3 months, 6 months, 12 months

Study Arms (3)

Jumpstart 1

EXPERIMENTAL

Questionnaire on advance care planning experiences, preferences, and concerns

Behavioral: JUMPSTART-ANAI

Jumpstart 2

ACTIVE COMPARATOR

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

Behavioral: JUMPSTART-ANAI

Usual care

NO INTERVENTION

Interventions

JUMPSTART-ANAIBEHAVIORAL

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 1Jumpstart 2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southcentral Foundation

Anchorage, Alaska, 99508, United States

RECRUITING

Study Officials

  • Jennifer Shaw, PhD

    University of Alaska Fairbanks

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Medlock

CONTACT

John Trainor, PhD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 5, 2024

Study Start

April 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

May 30, 2027

Last Updated

July 1, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

IPD will not be shared. All data owned by Tribal authority.

Locations