Advance Care PlanningR4RACPNCT06129149
The R4R Advance Care Planning Pilot Study
A study testing Trauma-Informed Care-adapted and Checklist-guided ACP intervention in people with Advance Care Planning, run by Vanderbilt University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- Trauma-Informed Care-adapted and Checklist-guided ACP intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2024to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- an adult (18+) residing in an affordable housing unit that does not have a completed advance directive
Who cannot join
- inability to provide informed consent or participate in the intervention due to cognitive, auditory, visual impairment or non-English language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Advance Care Planning
- Being tested
- Trauma-Informed Care-adapted and Checklist-guided ACP intervention
- Keywords
- advance care planning, affordable housing, housing insecurity, social determinants of health, trauma-informed care, qualitative research, implementation science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Informed Care-adapted and Checklist-guided ACP interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Trauma-Informed Care-adapted and Checklist-guided ACP intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 30-day post-intervention follow-up (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start14 May 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Kimpel, Vanderbilt University
- Investigators
- Kate Clouse, PhD, MPH, Principal investigator, Vanderbilt UniversityChristian Ketel, DNP, RN, FNAP, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129149
- Sponsor's protocol ID
- 231919
- Acronym
- R4RACP
- Status last verified
- Nov 2025
- First submitted
- 8 Nov 2023
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06129149
- Acronym / sponsor ID
- R4RACP / 231919
- Conditions
- Advance Care Planning
- Keywords
- advance care planning, affordable housing, housing insecurity, social determinants of health, trauma-informed care, qualitative research, implementation science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Trauma-Informed Care-adapted and Checklist-guided ACP interventionAll 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- an adult (18+) residing in an affordable housing unit that does not have a completed advance directive
Key exclusion criteria (1 listed)
- inability to provide informed consent or participate in the intervention due to cognitive, auditory, visual impairment or non-English language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-Informed Care-adapted and Checklist-guided ACP interventionThe 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. | Behavioural | Intervention |
Primary outcome
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
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
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.
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Advance Care Planning
Active, not recruiting
ACP Video Intervention for Patients With Life-Limiting Illness
Health Care Utilization, End Stage Disease
Recruiting
Patient Navigation and the Planning Advance Care Together Website to Improve Goals of Care Conversations in Hematopoietic Cell Transplant Survivors, IMPACT-HCT Trial
Hematopoietic and Lymphatic System Neoplasm
Not yet recruiting
Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
Advance Care Planning, American Indian or Alaska Native
Not yet recruiting
Development and Evaluation of a Disease-oriented Scenario Game to Promote ACP Among Older Adults and Family Caregivers
Heart Failure, Older Adults (65 Years and Older)
Active, not recruiting
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Clouse, PhD, MPH principal investigator
Vanderbilt University
Christian Ketel, DNP, RN, FNAP principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Informed Care-adapted and Checklist-guided ACP intervention in people with Advance Care Planning, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advance Care Planning Values/Beliefs (time frame: Baseline to 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.