The R4R Advance Care Planning Pilot Study

NCT06129149 | Completed Results DMC

• 1 other identifier: 231919
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Advance Care Planning

Keywords

advance care planning; affordable housing; housing insecurity; social determinants of health; trauma-informed care; qualitative research; implementation science

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (1)

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)

Behavioral: Trauma-Informed Care-adapted and Checklist-guided ACP intervention

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Urban Housing Solutions

Nashville, Tennessee, 37217, United States

Location

Limitations and Caveats

No comparison group. Nonprobability sampling. No adjusted statistical analysis due to small sample size Single site

Results Point of Contact

• Title: Christine Kimpel
• Organization: The Ohio State University

kimpel.28@osu.edu

614-247-1195

Study Officials

• Kate Clouse, PhD, MPH

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Christian Ketel, DNP, RN, FNAP

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: May 14, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: December 2, 2025
• Results First Posted: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years
• 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.

Locations

US (1)