R4RACP: The R4R Advance Care Planning Pilot Study

Sponsor

Vanderbilt University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06129149

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advance Care Planning	Behavioral: Trauma-Informed Care-adapted and Checklist-guided ACP intervention	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

May 1, 2024

Anticipated Primary Completion Date :

Feb 28, 2025

Anticipated Study Completion Date :

Feb 28, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Advance Care Planning Values/Beliefs [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 (Fried et al., 2012)
Advance Care Planning Processes [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, e.g., "I review my advance care documents so that I know what they say." (Fried et al., 2012)
Advance Care Planning Actions [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. (Fried et al., 2010)
Implementation Acceptability [30-day post-intervention follow-up (Visit 3)]
Implementation Acceptability Scale (Weiner et al., 2017)
Implementation Appropriateness [30-day post-intervention follow-up (Visit 3)]
Implementation Appropriateness Scale (Weiner et al., 2017)
Implementation Feasability [30-day post-intervention follow-up (Visit 3)]
Implementation Feasibility Scale (Weiner et al., 2017)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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