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Completed

NCT Number: NCT06129149

The R4R Advance Care Planning Pilot Study

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.

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Key information

Conditions

Advance Care Planning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urban Housing Solutions

Nashville, Tennessee, 37217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Advance Care Planning Values/Beliefs

    Time frame: Baseline to 30 days

    Advance Care Planning Values/Beliefs Scale, Possible scores: 7-35, Higher summed scores are worse, indicating a higher number of advance care planning misconceptions

  2. Advance Care Planning Processes

    Time frame: Baseline to 30 days

    Advance Care Planning Processes Scale; Possible scores: 15-75; Higher summed scores are better and indicate higher participation in advance care planning processes

  3. Advance Care Planning Actions

    Time frame: Baseline to 30 days

    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.

  4. Implementation Acceptability

    Time frame: 30-day post-intervention follow-up (Visit 3)

    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

  5. Implementation Appropriateness

    Time frame: 30-day post-intervention follow-up (Visit 3)

    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

  6. Implementation Feasability

    Time frame: 30-day post-intervention follow-up (Visit 3)

    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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Acronym: R4RACP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2023
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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