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
9mo 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
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 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

August 1, 2024

Last Update Submit

July 7, 2026

Conditions

Advance Care Planning

Outcome Measures

Primary Outcomes (1)

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

    New advance directive scanned into EHR

    Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (2)

  • Quality of communication

    Baseline, 3 months

  • Psychological distress

    Baseline, 3 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:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southcentral Foundation

Anchorage, Alaska, 99508, United States

RECRUITING

Related Publications (3)

  • Lillie KM, Dirks LG, Curtis JR, Candrian C, Kutner JS, Shaw JL. Culturally Adapting an Advance Care Planning Communication Intervention With American Indian and Alaska Native People in Primary Care. J Transcult Nurs. 2020 Mar;31(2):178-187. doi: 10.1177/1043659619859055. Epub 2019 Jul 1.

    PMID: 31258037BACKGROUND

  • Shaw J, Medlock S, Singh RS, Piromalli C, Trainor JK, Johnson R, Rollolazo S, Fieldhouse C, Mortenson R, Landes SJ. Evaluating a tailored communication tool to increase advance care planning among Alaska Native and American Indian people in primary care: A type 1 hybrid effectiveness-implementation cluster randomized trial protocol. Contemp Clin Trials. 2026 Jun;165:108305. doi: 10.1016/j.cct.2026.108305. Epub 2026 Apr 12.

    PMID: 41974413BACKGROUND

  • Singh RS, Landes SJ, Medlock S, Piromalli C, Mortenson R, Shaw J. Collaborative Implementation Planning to Jumpstart Advance Care Planning with Alaska Native and American Indian peoples in Primary Care. Res Sq [Preprint]. 2025 Sep 19:rs.3.rs-7400899. doi: 10.21203/rs.3.rs-7400899/v1.

    PMID: 41001527BACKGROUND

Study Officials

  • Jennifer Shaw, PhD

    University of Alaska Fairbanks

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Medlock, MS

CONTACT

(907)729-6322smedlock@scf.cc

John Trainor, PhD, MPH

CONTACT

jtrainor@scf.cc

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 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations

US(1)