Feasibility of a Patient Decision Aid for Advance Care Planning Among Adults With a History of Intensive Care Admission: A Pilot Randomized Trial

Abstract

This pilot randomized controlled trial investigated whether a patient decision aid (PtDA) could enhance preparedness for advance care planning (ACP) among participants treated in the intensive care unit (ICU) following surgery. Participants were recruited online through a private research company in Japan. The intervention group received a researcher-developed PtDA aligned with international standards, while the control group received an informational pamphlet. The SURE test, a screening tool for decisional conflict, was used as the primary outcome to assess confidence in health-related decision-making. A post-intervention web-based survey was also conducted to assess participants’ preferences for ACP support from healthcare professionals. The proportion of participants unable to make an ACP decision was significantly lower in the intervention group (P < .05); more participants scored 4 on the SURE test, indicating full decisional confidence (P < .05). Participants expressed needs for healthcare professional presence and psychological support during ACP discussions with families. These findings suggest that a PtDA may effectively enhance decision-making about ACP among ICU survivors, even outside clinical settings, and highlight its potential as a scalable tool supporting post-discharge ACP in community-based contexts.

Introduction

Advance care planning (ACP) is increasingly recognized as an essential process for ensuring that patients receive medical care consistent with their values, goals, and preferences, ¹ particularly in the context of high-risk surgery. ² The perioperative period, especially when postoperative intensive care unit (ICU) admission is anticipated, offers a critical opportunity for these discussions. However, ACP implementation remains challenging. ³ Historical perceptions of ACP as a taboo topic among surgeons, along with patients’ concerns that such discussions might result in the withholding of life-saving treatments,^4,5 have contributed to hesitancy among both providers and patients.

Patient decision aids (PtDAs) are designed to support this process by presenting available options, explaining potential benefits and harms, clarifying uncertainties, and facilitating reflection and articulation of preferences.^6,7 For patients, PtDAs can enhance understanding, promote shared decision-making, and increase confidence in their choices. ⁸ Evidence from perioperative ACP and advance directive studies suggests potential benefits, such as improved knowledge without increasing anxiety,^9,10 but robust evidence remains limited. Some studies have reported no significant impact on end-of-life care quality or documentation rates. ¹¹ Conversely, emerging findings indicate that the use of PtDAs before surgery may improve emergency preparedness needs comprehension, foster earlier communication with family members and healthcare providers, and increase patient comfort with decision-making.^10,12 However, to date, few studies have examined the effect of PtDAs on the quality of decision-making, defined as the extent to which patients make well-informed and value-consistent decisions that they feel confident about, in perioperative settings. This study aimed to address this gap by comparing ACP support alone with ACP support incorporating PtDAs among individuals who had undergone high-risk surgery and were admitted to the ICU postoperatively.

Methods

This was a randomized controlled trial involving nonclinical participants; health outcomes were not evaluated, and no clinical registry was used. This study was conducted in Japan. Participants were adults aged 20-79 years who had undergone surgery and were subsequently admitted to the ICU. Exclusion criteria included current cognitive impairment, physical or mental distress, and inability to live independently. In Japan, many physicians are concerned that discussing ACP with patients and families before high-risk surgery may increase their preoperative anxiety. ⁴ Moreover, implementing ACP support in clinical settings can be difficult without physicians’ understanding and cooperation. Therefore, participants were recruited from a national online panel of Japanese residents. The required sample size was calculated using a chi-squared test and a 2-group comparison. Based on previous survey data, ¹⁰ the estimated effect size was 0.6-0.7. Using an effect size of 0.6, an alpha of 0.05, and a power of 0.8, the required sample size was 45 participants per group (90 in total), calculated using G*Power 3.1^®.

Patient Decision Aids

PtDAs support shared decision-making by helping patients and families understand medical options, clarify values, and communicate with healthcare professionals. They complement, rather than replace, clinical communication by fostering reflection and informed dialogue. The PtDA is not intended to substitute for physicians’ explanations but to assist individuals in making choices based on their own values and preferences. Its primary purpose is to enhance understanding and support patients and families in value-based decision-making. The PtDA used in this study was developed through a systematic process proposed by Coulter ¹³ and in accordance with the International Patient Decision Aid Standards. ¹⁴ It was based on a comprehensive needs assessment with healthcare professionals, ¹⁵ former ICU patients, and family members ⁸ to identify essential ACP information and values. Usability and comprehension were tested through alpha testing with potential users, ⁴ and feasibility for clinical implementation was evaluated. ⁹ Feedback from patients and families was incorporated to ensure real-world acceptability.

The PtDA was designed to support 2 sequential ACP decisions: (1) whether to initiate ACP discussions with family or a surrogate, and (2) whether to choose life-prolonging treatment or palliative care if facing a poor-prognosis condition. Its core aim was to help participants reflect on values and communicate care preferences, not to direct treatment choices. The PtDA provided structured information and value clarification exercises to promote dialogue among patients, families, and providers. It was originally developed in Japanese to reflect local contexts and translated into English through a supervised forward–backward process.

Setting and Randomization

The target population comprised 1600 registered individuals who had undergone surgery. Participants were recruited from a nationwide online research panel managed by a major Japanese survey company, which includes over one million adults aged ≥20 years who voluntarily join social and health-related studies. Eligibility was confirmed via self-reported data indicating prior surgery followed by ICU admission. Physical or mental distress was screened using a self-administered questionnaire, and those who reported current distress were excluded. Participants also self-reported the postoperative period using categorical options (within 1 year, 1-2 years, 2-3 years, 3-4 years, 4-5 years, 5-10 years, or >10 years). Of the 136 individuals who met the initial eligibility criteria and applied, 24 were excluded at the screening stage because they were unable to provide either the name of the surgery they had undergone or the duration of their ICU stay. These details were required to verify their ICU admission history and ensure the reliability of participant eligibility. As a result, 112 participants were included as study participants. Randomization was conducted by the research company using stratified allocation by surgery type (malignant vs non-malignant) to ensure equal group sizes. Blocks of 4 participants were arranged in 6 patterns and assigned by computer. The survey was double-blinded. Participants accessed the study description and questionnaire online. Participants in the intervention group received a PtDA pamphlet that included structured information, guided reflection prompts, and value clarification exercises regarding ACP. In contrast, participants in the control group received a standard informational pamphlet containing general ACP explanations without any structured decision-support components. Thus, the PtDA represented an enhanced decision-support tool beyond standard informational care. All participants read the materials and completed the survey between March and April 2023.

Outcome Measures

The primary outcome was the SURE test. ¹⁶ This 4-item scale assesses decision confidence and readiness based on 4 domains: being sure of oneself, understanding information, weighing risks and benefits, and receiving encouragement. Each item is scored as “yes” (1 point) or “no” (0 points), with total scores ranging from 0 to 4. A total score of 4 indicates full confidence and the absence of decisional conflict, as validated in previous studies. ¹⁶

The SURE test was selected as the primary outcome because it has been validated as a brief and sensitive tool for detecting decisional conflict. ¹⁷ Compared with the Decisional Conflict Scale, which includes a greater number of items, the SURE test consists of only 4 items and can be implemented more easily in clinical settings with minimal participant burden. Given that this pilot trial aimed to examine the feasibility of ACP support for ICU survivors and explore its clinical applicability, the SURE test was considered appropriate for screening participants’ readiness and confidence to engage in ACP-related dialogue rather than assessing the full spectrum of decisional conflict. Identifying decisional conflict using a concise tool such as the SURE test can help healthcare professionals recognize when further discussion and support are needed. In this context, the PtDA was designed to facilitate value-based dialogue between patients, families, and clinicians, complementing professional communication. In addition, participants were surveyed regarding the type of support they wished to receive from healthcare providers when considering ACP using a multiple-choice questionnaire originally developed by the research team (Supplemental Material 2).

Statistical Analysis

For the numerical data, SPSS ver. 25.0 was used for statistical analysis. The primary aim was to assess the proportion of participants achieving a SURE score of 4, and test for differences between the intervention and control groups. The significance level was set at P < .05. For other items, basic statistics were calculated for the numerical data.

Ethical Considerations

This study was approved by the ethics committee of St. Luke's International University (approval number: 22A036). Participants were provided with written explanations of the survey's purpose, research methods, details of participation in and withdrawal from the survey, protection of personal information, and data management methods used in the study. All the study participants provided written informed consent. Furthermore, data, such as basic attributes, were coded to maintain participant anonymity.

Results

Each group included 52 participants (total 104); mean age was 55.8 ± 16.0 years (control) and 57.4 ± 15.9 years (intervention). When deciding whether to conduct ACP discussions, 11 participants in the control group and 3 participants in the intervention group reported that they were unable to decide on the options (P = .021) (Supplemental Material 3 and 4). The number of individuals with a SURE score of 4 was 25 in the control group and 35 in the intervention group (P = .037) (Table 1).

Table 1.

Post-Intervention Evaluation of the Participant.

	Control		Intervention
	n = 52	%	n = 52	%	P-Value a
Chapter 1
Sharing my ACP's wishes to surrogate decision-makers and family members
Share	41	78.8	42	80.8
Not share	3	5.8	6	11.5
I cannot decide	11	21.2	3	5.8	.021
SURE score
4	25	48.1	35	67.3	.037
3	4	7.7	5	9.6
2	12	23.1	3	5.8
1	6	11.5	6	11.5
0	5	9.6	3	5.8
Ease of understanding
Completely agree	16	30.8	22	42.3	.612
Strongly agree	27	51.9	25	48.1
Strongly disagree	9	17.3	5	9.6
Completely disagree	0	0.0	0	0.0
Someone with whom to share life-sustaining treatment
Marital partner/Partner	34	65.4	42	80.8	.077
Children	20	38.5	25	48.1	.322
Brothers and sisters	8	15.4	11	21.2	.447
Parents	9	17.3	9	17.3	1.000
Relative	0	0.0	2	3.8	.153
Friends	4	7.7	5	9.6	.727
No one	8	15.4	4	7.7	.220
Chapter 2
Wishes for treatment when recovery becomes difficult
I receive life-sustaining treatment	8	15.4	14	26.9
I withdraw or withhold	34	65.4	34	65.4
I cannot decide	14	26.9	4	7.7	.009
SURE score
4	29	55.8	42	80.8	.005
3	5	9.6	2	3.8
2	5	9.6	3	5.8
1	7	13.5	4	7.7
0	6	11.5	1	1.9
Ease of understanding
Completely agree	17	32.7	22	42.3	.895
Strongly agree	29	55.8	26	50.0
Strongly disagree	6	11.5	4	7.7
Completely disagree	0	0.0	0	0.0
Inadequate understanding of treatment b
Arrival resuscitation	14	26.9	8	15.4	.150
Mechanical ventilator	13	25.0	7	13.5	.136
Biventricular assist device	18	34.6	10	19.2	.077
Dialysis	15	28.8	7	13.5	.055
Use of drugs to maintain blood pressure	15	28.8	2	3.8	.001
Infusion solution and nutrition	10	19.2	4	7.7	.085
Blood transfusion	6	11.5	6	11.5	1.000
I understood everything.	22	42.3	33	63.5	.031

^aχ2-test.

^bMultiple answer.

When deciding whether to undergo life-prolonging treatment, 14 individuals in the control group and 4 individuals in the intervention group answered “I cannot decide” (P = .009). The number of participants with a SURE score of 4 was 29 in the control group and 42 in the intervention group (P = .005). After reading the materials, 22 individuals in the control group and 33 individuals in the intervention group answered that they understood all of the treatment content (P = .031). The most common request was for healthcare professionals to be present during the discussions (57 participants, 54.8%), followed by the provision of subsequent psychological support for surrogate decision-makers and family members (28 participants, 26.9%) (Table 2).

Table 2.

Perceptions of ACP Discussions (After Intervention).

	Total		Control		Intervention
	N = 104	%	n = 52	%	n = 52	%	P-Value a
Discussion with surrogate decision-makers
Not hard all	34	32.7	17	32.7	17	32.7
Not too hard	41	39.4	19	36.5	22	42.3
No opinion	16	15.4	9	17.3	7	13.5
Somewhat difficult	6	5.8	4	7.7	2	3.8
Very difficult	7	6.7	3	5.8	4	7.7
Need medical support in discussions with surrogate decision-makers?
Absolutely necessary	25	24.0	10	19.2	15	28.8
Need a lot of	30	28.8	18	34.6	12	23.1
Necessary depending on the content	37	35.6	21	40.4	16	30.8
Completely unnecessary	12	11.5	3	5.8	9	17.3	.125
The support you want from your medical provider when talking to a surrogate decision-maker
Attendance during the discussion	57	54.8	28	53.8	29	55.8	.844
Describe some plans for life-sustaining treatment or provision of materials	54	51.9	25	48.1	29	55.8	.556
Counseling on the method of deciding the surrogate decision-maker	31	29.8	15	28.8	16	30.8	.830
Mental support for surrogate decision-makers after discussion	28	26.9	11	21.2	17	32.7	.185
I do not have the support I want.	16	15.4	9	17.3	7	13.5	.587
I want to have a chance to discuss ACP with my physician
Completely agree	47	45.2	23	44.2	24	46.2
Strongly agree	49	47.1	27	51.9	22	42.3
Strongly disagree	5	4.8	2	3.8	3	5.8
Completely disagree	3	2.9	0	0.0	3	5.8
When is the right time to discuss this with your physician? b
Informed illnesses	60	57.7	36	69.2	24	46.2
Before surgery or new treatments	65	62.5	33	63.5	32	61.5
After treatment	32	30.8	17	32.7	15	28.8
When my condition gets worse while hospitalized	39	37.5	20	38.5	19	36.5
There's no right timing.	8	7.7	2	3.8	6	11.5

^aχ²-test.

^bMultiple answer.

Discussion

This study is the first to assess ACP decision-making readiness using PtDAs among postoperative ICU survivors. The findings suggest that PtDAs can reduce indecision and improve both decision confidence and comprehension compared with ACP information alone. These benefits may be particularly relevant in contexts outside of end-of-life care, where patients still face high-stakes treatment decisions.

The observed improvement in comprehension is noteworthy, as understanding of certain treatments often remains incomplete even after ICU discharge. This may be due to the complexity of distinguishing between life-saving and life-prolonging interventions in critical care. ¹⁸ Timely shared decision-making, with repeated confirmation of preferences as clinical conditions evolve, may help bridge these gaps and reduce potential conflicts between patients, families, and clinicians. In this survey, the SURE test was used for the primary outcome. This scale is simple, consisting of only four questions, and allows for the evaluation of whether a patient is ready to make a decision. ¹⁹ Thus, this scale may determine the results of ACP decisions. Additionally, even after completion of a patient's treatment, this scale may be used to assess whether the patient can understand their decisions and reflect on and communicate their values with the medical staff. In Japan, patients initially have the choice to visit an acute care hospital based on their judgment. As a result, few patients have the opportunity to engage in a thorough discussion with their physician about their illness and values. Medical professionals must recognize these situations and seize the opportunity to practice SDM with patients. Regarding research methods, considering the effects of ACP support by assessing it cross-sectionally over time, rather than assessing it once before treatment, is important. Additionally, considering measures to evaluate the effectiveness of ACP support is essential. ²⁰

The main limitations of this study include the recruitment of participants from an online panel rather than active clinical settings, which may introduce recall or selection bias. Furthermore, although participants were provided with PtDAs or ACP pamphlets, the degree to which they engaged with the materials could not be measured.

Conclusions

This study showed that using PtDAs to provide ACP support, grounded in patients’ ICU treatment experiences, may positively influence decision-making even among those not facing end-of-life situations. Incorporating PtDAs alongside coaching and counseling may enhance patients’ understanding of treatment options and improve decision-making quality. These findings highlight the potential value of integrating decision-support tools and coaching into ACP practice. Future research should assess the effectiveness of such combined interventions in diverse patient populations.