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Affordable housing residents continue to experience multi-faceted insecurity and advance care planning (ACP) challenges even after obtaining secure housing, resulting in significant inequities in quality of care during times of cognitive incapacity. To promote proactive planning for affordable housing residents, this proposal is for a pilot study to test a novel trauma-informed care adapted advance care planning intervention with the following aims: to test initial efficacy of the intervention on ACP outcomes (Aim 1) and determine resident perceptions of intervention acceptability, appropriateness, and feasibility and perceived implementation barriers and facilitators (Aim 2). These data will support the development of a larger scale study of ACP interventions within a resiliency-based hub model to comprehensively support whole-person care and proactive planning for times of cognitive incapacity.
Long-term objectives and goals. Vanderbilt University School of Nursing (VUSN) and Urban Housing Solutions (UHS) - the second largest provider of affordable housing in Nashville - are partners with the long-term goal of reducing health disparities among medically-underserved UHS residents in Nashville. This partnership is developing resiliency hubs that will provide essential services and support within a communal setting at the housing facility. Previous literature and data findings support that similar populations to this community lack information about and access to advance care planning (ACP), which specifies their healthcare wishes during cognitive incapacitation or end-of-life, and nationwide research shows significant disparities regarding ACP participation among low-income populations. The short-term goal of the proposed work is to pilot test a Hybrid type 1, single-arm, pre-post intervention to assess the initial efficacy and implementation outcomes of a trauma-informed care (TIC)-adapted ACP intervention to improve learning and communication for times of decisional incapacity among UHS residents, within the context of a resiliency hub model. This is a necessary first step for developing a long-term research portfolio dedicated to addressing ACP disparities and promoting equitable end-of-life planning among low-income, medically-underserved populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | All participants will participate in this single arm study consisting of three visits: visit 1 (baseline data collection), visit 2 (intervention followed by brief qualitative debrief interview), and visit 3 (30-day follow-up data collection) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma-Informed Care-adapted and Checklist-guided ACP intervention | Behavioral | The intervention will consist of a single one- to two-hour visit wherein the PI (Kimpel) will facilitate a flexible conversational approach with the resident (and, optionally, a healthcare decision-maker) in a quiet, private location in the resiliency hub. Using a conversation checklist adapted from a narrative synthesis of advance care planning (ACP) guides (Fahner et al., 2019), the PI will explore ACP with participants and use each visit to continually adapt the checklist and approach with trauma-informed care (TIC) principles: safety, trustworthiness and transparency, peer support, collaboration and mutuality, empowerment, and choice, and cultural, historical, and gender issues. Adverse Childhood Experiences and previous death-related experiences assessed during baseline data collection will be used to tailor the discussion to carefully explore relevant history to assess resident ACP values, preferences, and goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Advance Care Planning Values/Beliefs | Advance Care Planning Values/Beliefs Scale, Possible scores: 7-35, Higher summed scores are worse, indicating a higher number of advance care planning misconceptions | Baseline to 30 days |
| Advance Care Planning Processes | Advance Care Planning Processes Scale; Possible scores: 15-75; Higher summed scores are better and indicate higher participation in advance care planning processes | Baseline to 30 days |
| Advance Care Planning Actions | Stages of Change for Advance Care Planning Behaviors Scale; Possible Scores: 0-24; Higher summed scores are better and indicate higher levels of advance care planning participation. | Baseline to 30 days |
| Implementation Acceptability | Acceptability of Intervention Measure: Possible scores: 4-20; Higher scores indicate greater acceptability. The result is the percentage of the participants who had a score ≥15 as hypothesized | 30-day post-intervention follow-up (Visit 3) |
| Implementation Appropriateness | Intervention Appropriateness Measure: Possible scores: 4-20; Higher scores indicate greater appropriateness. The result is the percentage of the participants who had a score ≥15 as hypothesized | 30-day post-intervention follow-up (Visit 3) |
| Implementation Feasability | Feasibility of Intervention Measure: Possible scores: 4-20; Higher scores indicate greater feasibility. The result is the percentage of the participants who had a score ≥15 as hypothesized |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kate Clouse, PhD, MPH | Vanderbilt University | Principal Investigator |
| Christian Ketel, DNP, RN, FNAP | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urban Housing Solutions | Nashville | Tennessee | 37217 | United States |
Quantitative and qualitative data will be collected during this study. Due to the small size of our sample and the specificity of our recruitment locations, we have developed the following plan to share data while protecting participant privacy. De-identified data will be made available to individuals within Vanderbilt University to promote the research and training of the Vanderbilt community. We will share study materials with researchers outside of the institution, such as the study protocol , SAP, ICF, etc., upon individual request and with institutional permission.
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The data will become available 3 months following publication of outcomes and will remain available for at least 5 years
Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | All participants will participate in this single arm study consisting of three visits: visit 1 (baseline data collection), visit 2 (intervention followed by brief qualitative debrief interview), and visit 3 (30-day follow-up data collection) Trauma-Informed Care-adapted and Checklist-guided ACP intervention: The intervention will consist of a single one- to two-hour visit wherein the PI (Kimpel) will facilitate a flexible conversational approach with the resident (and, optionally, a healthcare decision-maker) in a quiet, private location in the resiliency hub. Using a conversation checklist adapted from a narrative synthesis of advance care planning (ACP) guides (Fahner et al., 2019), the PI will explore ACP with participants and use each visit to continually adapt the checklist and approach with trauma-informed care (TIC) principles: safety, trustworthiness and transparency, peer support, collaboration and mutuality, empowerment, and choice, and cultural, historical, and gender issues. Adverse Childhood Experiences and previous death-related experiences assessed during baseline data collection will be used to tailor the discussion to carefully explore relevant history to assess resident ACP values, preferences, and goals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One participant died before 30-day follow-up data could be collected, and their data was excluded from the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | All participants will participate in this single arm study consisting of three visits: visit 1 (baseline data collection), visit 2 (intervention followed by brief qualitative debrief interview), and visit 3 (30-day follow-up data collection) Trauma-Informed Care-adapted and Checklist-guided ACP intervention: The intervention will consist of a single one- to two-hour visit wherein the PI (Kimpel) will facilitate a flexible conversational approach with the resident (and, optionally, a healthcare decision-maker) in a quiet, private location in the resiliency hub. Using a conversation checklist adapted from a narrative synthesis of advance care planning (ACP) guides (Fahner et al., 2019), the PI will explore ACP with participants and use each visit to continually adapt the checklist and approach with trauma-informed care (TIC) principles: safety, trustworthiness and transparency, peer support, collaboration and mutuality, empowerment, and choice, and cultural, historical, and gender issues. Adverse Childhood Experiences and previous death-related experiences assessed during baseline data collection will be used to tailor the discussion to carefully explore relevant history to assess resident ACP values, preferences, and goals. |
| 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, Continuous | Median |
| 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 | Advance Care Planning Values/Beliefs | Advance Care Planning Values/Beliefs Scale, Possible scores: 7-35, Higher summed scores are worse, indicating a higher number of advance care planning misconceptions | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 30 days |
|
7 months
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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 | Intervention | All participants will participate in this single arm study consisting of three visits: visit 1 (baseline data collection), visit 2 (intervention followed by brief qualitative debrief interview), and visit 3 (30-day follow-up data collection) Trauma-Informed Care-adapted and Checklist-guided ACP intervention: The intervention will consist of a single one- to two-hour visit wherein the PI (Kimpel) will facilitate a flexible conversational approach with the resident (and, optionally, a healthcare decision-maker) in a quiet, private location in the resiliency hub. Using a conversation checklist adapted from a narrative synthesis of advance care planning (ACP) guides (Fahner et al., 2019), the PI will explore ACP with participants and use each visit to continually adapt the checklist and approach with trauma-informed care (TIC) principles: safety, trustworthiness and transparency, peer support, collaboration and mutuality, empowerment, and choice, and cultural, historical, and gender issues. Adverse Childhood Experiences and previous death-related experiences assessed during baseline data collection will be used to tailor the discussion to carefully explore relevant history to assess resident ACP values, preferences, and goals. |
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No comparison group. Nonprobability sampling. No adjusted statistical analysis due to small sample size Single site
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Kimpel | The Ohio State University | 614-247-1195 | kimpel.28@osu.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 | Nov 7, 2025 | Nov 7, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2024 | Dec 19, 2024 | ICF_000.pdf |
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|
| 30-day post-intervention follow-up (Visit 3) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Advance Care Planning Processes | Advance Care Planning Processes Scale; Possible scores: 15-75; Higher summed scores are better and indicate higher participation in advance care planning processes | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 30 days |
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| Primary | Advance Care Planning Actions | Stages of Change for Advance Care Planning Behaviors Scale; Possible Scores: 0-24; Higher summed scores are better and indicate higher levels of advance care planning participation. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 30 days |
|
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| Primary | Implementation Acceptability | Acceptability of Intervention Measure: Possible scores: 4-20; Higher scores indicate greater acceptability. The result is the percentage of the participants who had a score ≥15 as hypothesized | Posted | Count of Participants | Participants | 30-day post-intervention follow-up (Visit 3) |
|
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| Primary | Implementation Appropriateness | Intervention Appropriateness Measure: Possible scores: 4-20; Higher scores indicate greater appropriateness. The result is the percentage of the participants who had a score ≥15 as hypothesized | Posted | Count of Participants | Participants | 30-day post-intervention follow-up (Visit 3) |
|
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| Primary | Implementation Feasability | Feasibility of Intervention Measure: Possible scores: 4-20; Higher scores indicate greater feasibility. The result is the percentage of the participants who had a score ≥15 as hypothesized | Posted | Count of Participants | Participants | 30-day post-intervention follow-up (Visit 3) |
|
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| 1 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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