NCT05304117

Brief Summary

This project has three specific aims: (1) culturally tailor the content of the Make Your Wishes about You (MY WAY) ACP curriculum and guide for one American Indian tribe; (2) assess the feasibility of the culturally-tailored MY WAY ACP curriculum and patient education guide with the tribe; and (3) examine preliminary outcomes of the culturally-tailored MY WAY ACP curriculum and guide with 70 tribal members. Upon successful completion, it is expected that this project will develop a feasible culturally-tailored MY WAY that through a quasi-experimental waitlist design shows promise as an efficacious program with respect to self-efficacy, readiness, and ACP completion that increases facilitators and decreases barriers to ACP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 4, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

12 months

First QC Date

February 4, 2022

Results QC Date

July 9, 2024

Last Update Submit

June 16, 2025

Conditions

Keywords

American IndianAdvance Care PlanningSerious illnessend-of-life care

Outcome Measures

Primary Outcomes (3)

  • Count of Self-Report of Advance Directive

    The proportion of participants who self-report advance directive completion.

    Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)

  • Average Advance Care Planning -Engagement Readiness

    The mean ACP Readiness scores range from 1-6, with higher scores indicating greater readiness.

    Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)

  • Average Advance Care Planning-Engagement Self-Efficacy

    The mean ACP Self-Efficacy scores range from 1-6, with higher scores indicating greater self-efficacy. not at all, a little, somewhat, fairly, extremely Higher scores indicate better outcomes.

    Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)

Secondary Outcomes (2)

  • Average Number of Barriers to Advance Care Planning

    Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)

  • Average Number of Facilitators for Advance Care Planning

    Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)

Study Arms (2)

Advance Care Planning Experimental

EXPERIMENTAL

Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning.

Behavioral: Advance Care Planning

Advance Care Planning Waitlist

OTHER

Waitlist Group- Baseline control measures will be collected at consent and again 3-6 months later before attending a Community Information Session on advance care planning and an one-on-one Sharing Session about Advance Care Planning. Data will be collected again 8 weeks after the intervention.

Behavioral: Advance Care Planning

Interventions

Community Information Session and Private Sharing Session with trained social worker

Advance Care Planning ExperimentalAdvance Care Planning Waitlist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged ≥18 years
  • either enrolled member or spouse of enrolled member in tribal service area
  • Member of another American Indian/Alaskan Native tribe
  • English fluency
  • Resides in the tribal service area.

You may not qualify if:

  • Cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Carolina University

Asheville, North Carolina, 28723, United States

Location

Related Publications (2)

  • Schweinhart A, Goins RT, Anderson E. Results of a Culturally Tailored Advance Care Planning Intervention for American Indian Peoples: A Quasi-Experimental Waitlist-Controlled Trial. Innov Aging. 2025 May 6;9(6):igaf041. doi: 10.1093/geroni/igaf041. eCollection 2025.

  • Anderson E, Goins RT, Haozous EA, Schweinhart A. Testing a Culturally Tailored Advance Care Planning Intervention (MY WAY) for an American Indian Tribe: Protocol for a Quasi-Experimental Waitlist Control Design. JMIR Res Protoc. 2023 Dec 29;12:e50654. doi: 10.2196/50654.

MeSH Terms

Interventions

Advance Care Planning

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Dr. R Turner Goins
Organization
Western Carolina University

Study Officials

  • R T Goins, PhD

    Western Carolina University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Social Work

Study Record Dates

First Submitted

February 4, 2022

First Posted

March 31, 2022

Study Start

February 4, 2022

Primary Completion

January 30, 2023

Study Completion

March 8, 2024

Last Updated

July 3, 2025

Results First Posted

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations