Culturally Tailoring an Advance Care Planning Intervention for American Indians

Advance Care Planning Clinical Trial

Official title:

Culturally Tailoring an Advance Care Planning Intervention for American Indians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304117
• Other study ID #: 1685879-1
• Status: Completed
• Phase: N/A
• Start date: February 4, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: December 2023
• Source: Western Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Research Design. A quasi-experimental waitlist study design will be used to test the hypothesis that the intervention participants will experience increased ACP self-efficacy, readiness, and completion rates. It is also expected that the intervention participants will experience increased facilitators and decreased barriers to ACP. A control sample of waitlist participants will be used.

Based on the odds of completing an ACP indicated in previously implemented MY WAY interventions and using 90% power as a threshold, it is estimated that will be a need for at least an n = 60 to find effects. The intervention group, Cohort 1, will be those who participated in the first round of both the Community Educational Sessions and Sharing Sessions. The control group, Cohort 2, will be those who participated in the second round of both the Community Education Sessions and Sharing Sessions.

Measurement. Process Measures that are a part of the 9-item ACP Engagement Survey that includes measurement of self-efficacy and readiness, identified from Behavioral Change Theory, will be used. Self-efficacy and readiness subscales have Likert responses of "not at all, a little, somewhat, fairly, extremely" and have good reliability and discriminant validity. Barriers and Facilitators to ACP Questionnaire used in the MY WAY randomized controlled trial will be used. Pretest interviews with these measurements will be conducted by telephone or in person at the time of pre-registration for both cohorts by the Project Coordinator and team members.

Cohort 1 will be interviewed five times: Baseline pretest, Community Information Session Evaluation; Sharing Session Evaluation, 8 week-post test and 6 month post-test.

Cohort 2 will be interviewed five times: Baseline pretest, 2nd baseline control pretest, waitlist Community Information Session evaluation, and waitlist Sharing Session evaluation, 8 week post test.

The first interview at registration will serve as baseline for the waitlist group, Cohort 2. Cohort 2 will be contacted again approximately 6 months later and two-weeks prior to the second Community Education Session to remind them of their registration and to re-interview them for their intervention pretest. Posttest interviews will also be conducted by the Project Coordinator eight weeks post Sharing Session for both groups to capture ACP self-efficacy, readiness, and completion rates.

Statistical Analyses. Demographic characteristics will be examined using descriptive statistics (frequencies, measures of central tendency, measures of variation) and stratified analyses (e.g., delineating measures by demographics, attendance, ACP agreement etc.) to examine the association between demographics and program outcomes. ACP Engagement and the Barriers and Facilitators to ACP Questionnaire (ACP measures) will be compared between those who do and do not engage in Sharing Sessions and between Cohort 1 and Cohort 2. The tribal community as well as location of Community Education Session will be included in all analyses as nested participant variables to ensure that differences between tribal communities and education delivery do not significantly change results. To account for these nested variables, hierarchical linear modeling or a similar method will be used in comparison analyses. It is likely that there will be significant attrition from Community Education Sessions to Sharing Sessions. A Heckman Selectivity analyses will be used to determine if there are differences between those who complete the full intervention and those who complete only baseline measures or Community Educational Sessions. Due to the nature of the study, there may also be attrition due to death. If there are differences in attrition, the inverse Mill's ratio will be used in all further analyses. Comparison of baseline measures from pre-registration interviews will serve to ensure that there are no significant differences between the cohorts.

After these preliminary analyses, change in Cohort 1's ACP measures can be compared to changes from baseline to the waitlist pretest measures from Cohort 2. Since Cohort 2 received no intervention in the first 6 months, the analysis will control for natural variations over time and any measures which show significantly larger change in Cohort 1 can be attributed to the intervention. Cohorts 1 and 2 can then be combined to examine intervention effects (i.e., change from pretest to posttest) in the full sample of participants who experienced the Sharing Sessions; baseline results for Cohort 1 will be combined with waitlist pretest results for Cohort 2 and compared to the combined group of 70 Sharing Sessions' posttests. Finally, the combined cohorts will be compared to a subsample of matched participants who experienced the Community Education Sessions only to determine how each step in MY WAY affects the outcome ACP measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: February 1, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Cognitively impaired

Related Conditions & MeSH terms

• Advance Care Planning

Intervention

Behavioral:
• Advance Care Planning
Community Information Session and Private Sharing Session with trained social worker

Locations

Country	Name	City	State
United States	Western Carolina University	Asheville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Western Carolina University	Pacific Institute for Research and Evaluation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-Report of Advance Directive	The proportion of participants who self-report advance directive completion or Medical Order for Scope of Treatment (MOST) completion in follow up survey	Cohort 1: baseline, 8 weeks after baseline and 6 months after baseline; Cohort 2: baseline, 2nd pretest 6 months after baseline, 8 weeks after 2nd pretest
Primary	Change in Advance Care Planning Engagement Survey Score Change	The mean ACP Engagement Survey Score Survey. Scores range from 1-5, with higher scores indicating higher engagement.	Cohort 1: baseline, 8 weeks after baseline and 6 months after baseline; Cohort 2: baseline, 2nd pretest 6 months after baseline, 8 weeks after 2nd pretest
Secondary	Change in Barriers to Advance Care Planning	The sum (0-8) ACP Barriers Score with higher scores indicating more barriers.	Cohort 1: baseline, 8 weeks after baseline and 6 months after baseline; Cohort 2: baseline, 2nd pretest 6 months after baseline , 8 weeks after 2nd pretest
Secondary	Cohort 1: baseline, 8 weeks after baseline and 6 months after baseline; Cohort 2: baseline, 2nd pretest 3 months after baseline , 8 weeks after 2nd pretest	The sum (0-8) of ACP Facilitators Score survey, with higher scores indicating more facilitators.	Cohort 1: baseline, 8 weeks after baseline and 6 months after baseline; Cohort 2: baseline, 2nd pretest 6 months after baseline, 8 weeks after 2nd pretest