The R4R Advance Care Planning Pilot Study (R4RACP)

Resources for Resiliency (R4R) Advance Care Planning: A Pilot Study to Test a Trauma-Informed Care-adapted Advance Care Planning Intervention Among Affordable Housing Residents in Nashville

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.

Study Overview

• Status: Completed
• Conditions: Advance Care Planning
• Intervention / Treatment: Behavioral: Trauma-Informed Care-adapted and Checklist-guided ACP intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37217
      • Urban Housing Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• an adult (18+) residing in an affordable housing unit that does not have a completed advance directive

Exclusion Criteria:

• inability to provide informed consent or participate in the intervention due to cognitive, auditory, visual impairment or non-English language barrier

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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)

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	30-day post-intervention follow-up (Visit 3)

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Kate Clouse, PhD, MPH, Vanderbilt University; Principal Investigator: Christian Ketel, DNP, RN, FNAP, Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2024
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: implementation science; social determinants of health; advance care planning; qualitative research; housing insecurity; affordable housing; trauma-informed care
• Other Study ID Numbers: 231919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No