Trial Outcomes & Findings for The R4R Advance Care Planning Pilot Study (NCT NCT06129149)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Baseline to 30 days

Results posted on

2025-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	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) 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.
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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) 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.
Overall Study Death	1

Baseline Characteristics

The R4R Advance Care Planning Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=30 Participants 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) 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.
Age, Continuous	60 years n=121 Participants
Sex: Female, Male Female	14 Participants n=121 Participants
Sex: Female, Male Male	16 Participants n=121 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=121 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=121 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=121 Participants
Race (NIH/OMB) Asian	0 Participants n=121 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=121 Participants
Race (NIH/OMB) Black or African American	17 Participants n=121 Participants
Race (NIH/OMB) White	11 Participants n=121 Participants
Race (NIH/OMB) More than one race	2 Participants n=121 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=29 Participants 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) 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.
Advance Care Planning Values/Beliefs 30-days post-intervention	26.3 Score on a scale Standard Deviation 4.5
Advance Care Planning Values/Beliefs Baseline	24.9 Score on a scale Standard Deviation 6.1

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=29 Participants 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) 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.
Advance Care Planning Processes Baseline	29.2 Score on a scale Standard Deviation 11.9
Advance Care Planning Processes 30-days post-intervention	43.8 Score on a scale Standard Deviation 14.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=29 Participants 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) 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.
Advance Care Planning Actions Baseline	8.6 Score on a scale Standard Deviation 7.0
Advance Care Planning Actions 30-days post-intervention	12.6 Score on a scale Standard Deviation 5.9

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=29 Participants 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) 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.
Implementation Acceptability	29 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=29 Participants 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) 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.
Implementation Appropriateness	24 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=29 Participants 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) 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.
Implementation Feasability	28 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christine Kimpel

The Ohio State University

Phone: 614-247-1195

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place