The R4R Advance Care Planning Pilot Study

Advance Care Planning Clinical Trial

— R4RACP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129149
• Other study ID #: 231919
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2024
• Source: Vanderbilt University
• Contact: Christine C Kimpel, PhD, RN, MA
• Phone: 615-343-0845
• Email: christine.c.kimpel[@]vanderbilt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Care Planning

Intervention

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.

Locations

Country	Name	City	State
United States	Urban Housing Solutions	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 (Fried et al., 2012)	Baseline to 30 days
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, e.g., "I review my advance care documents so that I know what they say." (Fried et al., 2012)	Baseline to 30 days
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. (Fried et al., 2010)	Baseline to 30 days
Primary	Implementation Acceptability	Acceptability of Intervention Measure: Possible scores: 4-20; Higher scores indicate greater acceptability (Weiner et al., 2017).	30-day post-intervention follow-up (Visit 3)
Primary	Implementation Appropriateness	Intervention Appropriateness Measure: Possible scores: 4-20; Higher scores indicate greater appropriateness (Weiner et al., 2017).	30-day post-intervention follow-up (Visit 3)
Primary	Implementation Feasability	Feasibility of Intervention Measure (Weiner et al., 2017): Possible scores: 4-20; Higher scores indicate greater feasibility (Weiner et al., 2017).	30-day post-intervention follow-up (Visit 3)