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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21NR019910-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Pacific Institute for Research and Evaluation | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advance Care Planning Experimental | Experimental | Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advance Care Planning | Behavioral | Community Information Session and Private Sharing Session with trained social worker |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Barriers to Advance Care Planning | The sum (0-8) ACP Barriers Score with higher scores indicating more barriers. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
• Cognitively impaired
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| Name | Affiliation | Role |
|---|---|---|
| R T Goins, PhD | Western Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Carolina University | Asheville | North Carolina | 28723 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40520470 | Derived | 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. | |
| 38157237 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Advance Care Planning Experimental | Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning. Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker |
| FG001 | Advance Care Planning Waitlist | Waitlist Group- Baseline control measures will be collected at the same time as Cohort 1 completes their pretest. Six Months after Cohort 1, participants will be pretested again before attending a Community Information Session on advance care planning and an one-on-one Sharing Session about Advance Care Planning. Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Advance Care Planning Experimental | Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning. Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker |
| BG001 | Advance Care Planning Waitlist |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Count of Self-Report of Advance Directive | The proportion of participants who self-report advance directive completion. | Posted | Count of Participants | Participants | 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) |
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Through study completion, up to 8 months.
This intervention was voluntary and participants provided informed consent prior to enrollment. There is little data that suggests that advance care planning causes adverse effects. The intervention instructed participants that they could stop at any time. Support Stars and Project Coordinator worked closely with participants over time and were instructed to inform PIs of any potential adverse events, but none were noted. PI's learned of 3 participants deaths throughout the study, unrelated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Advance Care Planning Experimental | Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning. Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. R Turner Goins | Western Carolina University | 828.227.3515 | rtgoins@wcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2024 | Jul 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D032722 | Advance Care Planning |
| ID | Term |
|---|---|
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Average Number of Facilitators for Advance Care Planning | The sum (0-8) of ACP Facilitators Score , with higher scores indicating more facilitators. | 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) |
Waitlist Group- Baseline control measures will be collected at the same time as Cohort 1 completes their pretest. Six Months after Cohort 1, participants will be pretested again before attending a Community Information Session on advance care planning and an one-on-one Sharing Session about Advance Care Planning. Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Advance Care Plans | Count of Participants | Participants |
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Waitlist Group- Baseline control measures collected at consent, and again 3-6 months later before attending a Community Information Session on advance care planning and a one-on-one Sharing Session about Advance Care Planning. Data also collected 8 weeks post intervention. |
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| Primary | Average Advance Care Planning -Engagement Readiness | The mean ACP Readiness scores range from 1-6, with higher scores indicating greater readiness. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Secondary | Average Number of Barriers to Advance Care Planning | The sum (0-8) ACP Barriers Score with higher scores indicating more barriers. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Secondary | Average Number of Facilitators for Advance Care Planning | The sum (0-8) of ACP Facilitators Score , with higher scores indicating more facilitators. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| 3 |
| 105 |
| 0 |
| 105 |
| 0 |
| 105 |
| EG001 | Advance Care Planning Waitlist | Waitlist Group- Baseline control measures will be collected at the same time as Cohort 1 completes their pretest. Six Months after Cohort 1, participants will be pretested again before attending a Community Information Session on advance care planning and an one-on-one Sharing Session about Advance Care Planning. Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker | 0 | 41 | 0 | 41 | 0 | 41 |
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