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Abstract
Introduction Critically ill patients in intensive care units (ICUs) receive life-sustaining treatments aimed at restoring or maintaining organ function. ICU admission often involves substantial multidimensional suffering that can burden patients, their families and surrogates. Multidisciplinary palliative care support can help alleviate their sufferings. In South Korea, however, palliative care has not yet been integrated into critical care settings, highlighting the need to explore the feasibility of its implementation within the ICU.
Methods and analysis This study aims to test the feasibility of a consultation-based palliative care intervention in the ICU. The study will include 20 patients admitted to the ICU of a tertiary hospital due to sudden severe acute brain injury or progressive organ failure, along with their family caregivers. A palliative care team, comprising a social worker and a palliative care physician, will provide consultations to the ICU healthcare professionals based on the palliative care needs, following family counselling. Additional family meetings will be held if necessary. The primary outcomes will include participation rates, family counselling rates and study completion rates. The intervention’s potential impact will be assessed by changes in surrogate decision-making conflict, self-efficacy, depression and anxiety, post-decision regret and the experience of patient-centred and family-centred care. The demand and acceptability of the intervention will be assessed through semi-structured interviews with family surrogates, followed by qualitative analysis.
Ethics and dissemination This study will be conducted in accordance with the Declaration of Helsinki and applicable national laws and regulations. The clinical study protocol, along with any protocol amendments and the informed consent form, has been approved by the Institutional Review Board of the Hospital (2404-111-1532). We plan to submit the study results for presentation at conferences and for publication in international peer-reviewed journals. Data will also be made available on request to participants, funding agencies and interested researchers.
Trial registration number NCT06490835.
- Intensive Care Units
- PALLIATIVE CARE
- Decision Making
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Strengths and limitations of this study
Prospective single-arm prepost design to explore feasibility in an ICU setting.
Inclusion criteria targeting patients with severe acute brain injury or advanced organ failure.
Integration of both ICU healthcare professionals and family caregivers in data collection processes.
Use of mixed-methods combining quantitative outcomes and qualitative interviews.
Lack of a control group limits causal inference.
Introduction
Advancements in medical technology have improved the standard of care for critically ill patients and expanded treatment options. Nevertheless, mortality rates among patients in intensive care units (ICUs) remain high.1–3 Critically ill patients in ICUs face significant challenges in making treatment decisions, including life-sustaining treatments, arising from factors such as the sudden onset of illness, uncertainty about prognosis, including potential recovery and disability, the involvement of various healthcare professionals due to complex medical issues, temporary or long-term limitations in decision-making capacity caused by the illness, and ethical conflicts.4–6
Families of critically ill patients experience psychological distress due to the illness of their loved ones and encounter various challenges during surrogate decision-making, including insufficient information,7–11 uncertainty and confusion about values,12 13 communication issues11 14–16 lack of support,17–19 and time constraints.9 Consequently, they may experience psychological stress such as guilt or regret,9 20–22 as well as psychiatric symptoms, including depression, anxiety,23 24 and posttraumatic stress disorder.25–29 To alleviate these challenges, providing information on the benefits and risks of the treatment options, clarifying personal values regarding the potential outcomes, and offering guidance and support from healthcare professionals is essential.
The need for palliative care in the ICU has already been supported.1 30 31 The core areas of ICU palliative care include symptom management, effective communication, development of care plans that reflect the patient’s values and preferences, support for surrogate decision-makers, coordination of care transitions, workforce support, and the provision of psychological and emotional support to both patients and families, including bereavement care.30 32–34 ICU palliative care can offer enhanced symptom relief, higher satisfaction among patients, families, and healthcare providers, and improve overall quality of medical care.31 Additionally, ICU palliative care has been shown to have economic benefits, such as reducing ICU length of stay and lowering end-of-life (EOL) costs in hospitals.35 36
A multidisciplinary team approach is essential to meet the complex palliative care needs of patients and their families. This approach can be implemented in two ways: by forming a multidisciplinary team within the ICU to provide palliative care directly, or by having a specialist palliative care team offer consultations to the primary ICU team.32 37 The specialist palliative care addresses the needs of the referring primary ICU team while counselling the patient and family to identify their key values and preferences. They solidify patient-centred care goals and provide feedback to the primary ICU team to facilitate shared decision-making.38
In South Korea, however, palliative care is not yet integrated into critical care settings, resulting in a lack of appropriate palliative care for ICU patients with poor prognoses. Moreover, national hospice palliative care services include only cancer patients in outpatient or general ward settings; it does not encompass the ICU setting. There remains a considerable gap in the provision of palliative care for non-cancerous diseases.39 Therefore, this study investigates a consultation-based palliative care model as a feasible approach in the ICU environment in South Korea. This study aims to present the intervention protocol, detailing the process, components, and outcomes of the intervention.
Methods and analysis
Study design and setting
This clinical study utilises a single-arm pre-post intervention design to explore the feasibility of applying consultation-based palliative care services to provide high-quality palliative care to families of critically ill patients in ICUs. Recruitment commenced in June 2024 and is anticipated to continue until June 2025. During this period, efforts are directed towards securing the maximum possible number of analyzable cases meeting the inclusion/exclusion criteria among critically ill patients admitted to the ICU. The expected recruitment target is 20 cases (comprising 20 patients and their 1:1 matched family caregiver, totaling 40 individuals). The sample size was determined based on the average annual number of palliative care consultations requested from the ICU at this tertiary hospital. An average of 60 palliative care consultations were requested each year from the emergency ICU, with approximately 30 involving patients with non-cancer illnesses, who represent the target population of this study. Based on this, fewer than 30 patients per year were estimated to meet the eligibility criteria. Therefore, a target sample size of 20 patients was deemed feasible for this exploratory study assessing feasibility and acceptability of the intervention. All subsequent data collection is projected to be completed by December 31, 2025. The study protocol has been registered at ClinicalTrials.gov (NCT06490835).
This study is conducted within the emergency ICU of a tertiary hospital in South Korea with approximately 1800 beds, providing care for critically ill patients from across the country. The 20-bed emergency ICU operates as a closed unit, with separate teams of doctors and nurses providing 24-hour care throughout the year. This ICU team traditionally manages the palliative care needs of critically ill patients, including symptom management and discussions about treatment plans. The intervention in this study comprises a palliative care consultation team (PCCT), which includes a palliative care physician and a social worker, collaborating with an ICU attending physician (figure 1).
Scheme of consultation-based palliative care services to provide high-quality palliative care to families of critically ill patients in the ICU. The arrows indicate the flow of consultation processes between the palliative care team, ICU physicians, patients, and families. ICU, intensive care unit.
Eligibility criteria
Detailed inclusion and exclusion criteria for patients and family caregivers are summarised in table 1. Patients are selected based on diagnoses of severe acute brain injury or advanced organ failure, meeting specific criteria for Glasgow Coma Scale, an acute physiology and chronic health evaluation (APACHE) II score, and ICU stay duration. Family caregivers must meet age and consent requirements. Exclusion criteria include individuals under 19 years of age, recent active cancer treatment, refusal of palliative care consultation, or other conditions detailed in table 1. Patients expected to die within 48 hours were excluded, as the structured palliative care consultation process requires sufficient time for meaningful implementation, including family counselling and decision-making support. In South Korea, where there is no formal proxy system, healthcare decision-making is limited to spouses and direct blood relatives; therefore, palliative care discussions were confined to these individuals.
Eligibility criteria
Recruitment of participants
Attending physicians of the primary ICU team, who serve as co-investigators in this study, initially assess whether patients admitted to the ICUs meet the eligibility criteria. He or she refers patients deemed eligible as participants to the PCCT using a separate referral form within the electronic medical record system (see online supplemental file 1). The referral form includes confirmation of the patient’s verbal consent to participate in the study, along with detailed information regarding the patient’s medical condition, treatment plans, discussions with the family, and reasons for the referral. Then, the social worker from the PCCT delivers a comprehensive explanation of the study’s purpose and methods to potential participants. Written consent is obtained if they willingly express their intention to participate (see online supplemental file 2). After obtaining the consent, the palliative care physician from the PCCT reviews the patient’s medical records and the referral form. If there is insufficient information, the palliative care physician discusses the case with the ICU physician either in person or over the phone. Description of intervention
Overview
The aim of the intervention is to offer psychosocial support to the patient’s family, decision making support, and to enhance patient-centeredness. The intervention received by ICU patients and their families encompasses services provided by the PCCT and high-quality palliative care administered by the ICU attending physician, in addition to standard critical care. Key components of services from the PCCT include family counselling, family meeting support, and consultation on addressing identified palliative care needs through patient assessment and family counselling (table 2). If a participant requests to discontinue the intervention at any point, the intervention will be paused, and the participant will be allowed to withdraw from the study. The overview of the intervention is shown in figure 2.
Major interventions of the PCCT
Overall flow of the intervention. ICU, intensive care unit.
Family counseling
Family counselling by the PCCT social worker is a supportive and therapeutic process that also gathers information to assess the palliative care needs of the patient and family. Using a patient- and family-centred approach, particularly for families in distress, the social worker encourages all family members to express their opinions and emotions, promotes communication, and helps to explore the patient’s values and preferences. The social worker conducts a psychosocial assessment that includes the patient’s personal history, psychological and emotional status, family evaluation, socioeconomic support needs, and available resources. Additionally, a decision-making assessment is performed, encompassing factors related to family decision-making, dealing with uncertainty in current medical decisions, providing sufficient information, clarifying values, addressing communication issues, and facilitating shared decision-making. These assessments are conducted to provide foundational information for the PCCT in advising the attending physician and establishing intervention plans, including family meetings.
The social worker contacts participants to schedule 1 hour counselling appointments, aiming for all family members, including the primary caregiver, to gather in a private space. While face-to-face counselling is preferred, phone counselling is available if necessary. Sessions are recorded and transcribed for documentation.
Interim consultation
The interim consultation provides the ICU team with comprehensive guidance on the management of symptoms, understanding of the disease and treatment options by the patient and family, decisional conflict, and communication to ensure the provision of high-quality palliative care. Additionally, when a family meeting is necessary, the reasons for recommending the meeting and the required preparations are provided in the form of a response to the referral. If a family meeting is deemed unnecessary, the interim consultation is bypassed, and the process proceeds directly to the final consultation.
Support for family meetings
Additional family meetings tailored to the family’s needs are conducted as necessary. A family meeting, convened by an ICU attending physician as part of usual care, supports decision-making between healthcare professionals and the family to establish treatment and care plans. These meetings address the need for comprehensive multidisciplinary medical judgement, and to overcome high medical uncertainty, insufficient information, value conflicts in decision-making, and communication issues. During the intervention, the PCCT has supporting roles in resolving complex issues and mediating conflicts in the family meeting. While family meetings follow basic procedures, they can be adjusted to fit specific purposes and situations (table 3).
Basic procedures and roles of family meetings
Final consultation
Expanding on the content of the interim consultation (symptom management, understanding of the disease and decision-making conflict factors, psychosocial support, and communication), the final consultation encompasses care goal setting in the patient’s best interest and decision support aligned with these care goals. It also includes information on available support systems, support for EOL care and the bereavement process, and final recommendations in the form of an interdepartmental referral response.
High-quality palliative care by ICU attending physicians
The attending physicians appropriately integrate the recommendations of the PCCT into patient care and treatment, adjusting the goal of care and connecting necessary resources. The physicians also assess the need for further discussions, considering potential changes in the patient’s condition or goal of care.
Outcomes
The primary outcome is the feasibility of applying consultation-based high-quality palliative care, determined by the proportion of eligible individuals who participate, undergo family counselling, and complete the study. All secondary outcomes are exploratory in nature, intended to generate hypotheses and inform future research, given the limited sample size. Secondary outcomes include changes in family caregiver’s decisional conflict, self-efficacy, psychological distress, and decision regret as effects of intervention. Additional secondary outcomes are the level of patient- and family-centred care experienced by the caregiver,40 41 caregiver satisfaction with the services, length of hospital stay, survival discharge rate, and details of comfort care during ICU stay. Data collection completion rate and patient recruitment time are also included. To address the limitation of a small sample size in this study and to enhance the reliability of the research findings, a qualitative assessment of the feasibility and satisfaction with the intervention will also be conducted as a supplementary measure. Additionally, relevant data up to the point of withdrawal will be included in the analysis to ensure comprehensive reporting. table 4 outlines the timing and methods for collecting all outcome measures and survey variables.
Outcome measures
Statistical analysis
The outcome measures encompass both categorical variables and continuous variables. For continuous outcomes measuring changes before and after the intervention, a paired t-test or Wilcoxon signed-rank test will be utilised. Categorical variables will be assessed using frequencies (%). All statistical analyses will be two-sided, with a value of p<0.05 considered statistically significant.
Ethics and dissemination
The study protocol has received approval from the Institutional Review Board of Seoul National University Hospital (No. 2404-111-1532). The results of this study will be shared with critical care societies, interested researchers, and funding agencies. We intend to disseminate the findings extensively through multiple channels, including presentations at academic conferences, submissions to peer-reviewed journals, and posts on relevant social media platforms. Additionally, the study results will be submitted to ClinicalTrials.gov for broader accessibility.
Discussion
To the best of our knowledge, our study is the first to investigate the feasibility of implementing consultation-based, high-quality palliative care services in an ICU setting where specialist palliative care is not routinely available. Previous studies have indicated that palliative care consultations in the ICU tend to be provided too close to the time of death, limiting their potential benefits.42 This highlights the need for research exploring the feasibility and effects of interventions that provide early palliative care to patients who might benefit the most from it.43 In this context, our intervention is significant, as it identifies patients who could benefit from palliative care early on, integrating specialist palliative care into critical care to deliver high-quality palliative care from the outset.
In our study, the selected palliative care intervention focuses on delivering palliative care tailored to the overall situation of the patient and family through early consultation. This approach ensures continuous and effective interaction and communication between the primary ICU team and the patient’s family throughout the ICU care process. Various models of ICU palliative care delivery exist, such as consultative and integrative.44 In an environment lacking established ICU palliative care, we opted for an intervention model where the PCCT’s role is not to consistently manage symptoms directly, but rather to enhance the capacity for primary palliative care through consultation.45 46 This approach aims to enhance the delivery of palliative care while efficiently utilizing limited resources,47 positioning the PCCT as facilitators and mediators. Unlike previous studies,40 43 46 48 49 which predominantly employed independent roles of PCCT or interventions in terms of quality improvement within the primary ICU team, our approach presents a context-specific, pragmatic adaptive, consultative model. Here, PCCT acts as a facilitator, selectively supporting cases with complex needs to enhance primary palliative care capacity. This targeted strategy optimizes resource use while improving the overall quality of palliative care delivery in the ICU.
In previous studies on ICU palliative care interventions,43 46–48 the primary outcomes were typically subjective measures, such as family satisfaction and depression, or clinical outcomes for patients. Our study shares the limitation of difficulty in assessing patient outcomes due to the medical conditions of ICU patients, but it stands out by including person-centered care outcomes, like the Patient Perception of Patient‐Centeredness Questionnaire,41 proxy-reported by caregivers as a secondary outcome. As a feasibility study with an exploratory focus, we aimed to incorporate a range of outcomes from patient and family perspectives, as well as healthcare system and process aspects, while qualitatively evaluating those less suited to quantitative assessment.
Despite these strengths, our study has several limitations. First, we used a single-arm design for the pilot trial at a single center. Since PCCTs for ICUs are not widely implemented across healthcare institutions, and our intervention included both the PCCT and primary palliative care by ICU attending physicians, we considered a randomized design unsuitable for this pilot study. Second, the small sample size and single-arm pre-post design limit statistical power and introduce potential confounding. Patient-specific factors—such as underlying conditions, prior ICU management, and ICU length of stay—may influence outcomes. While relevant clinical variables will be recorded to aid interpretation, all secondary outcomes should be considered exploratory and hypothesis-generating. Furthermore, defining a standard target for feasibility is challenging due to variations in ICU palliative care delivery across healthcare systems. To address these issues, qualitative methods were incorporated to provide contextual insights and support comprehensive evaluation. Third, patients expected to die within 48 hours were excluded. As the structured palliative care consultation requires a minimum window for effective implementation, immediate end-of-life care in such cases is more appropriately provided by ICU clinicians. Future studies could explore rapid-response palliative care models or enhanced ICU-based primary palliative care to support families facing imminent death. Finally, our study only included ICU physicians as direct participants, even though ICU nurses play a critical role in palliative care.50 This may limit the interpretation of our intervention’s potential impact. However, given our focus on decision-making support, we prioritized enhancing ICU physicians' competency.
In conclusion, this study would have the potential to investigate the provision of high-quality palliative care via a consultative palliative care model integrated into ICU care as a feasible and acceptable approach. The results of this study can give insights for modelling the effective palliative care delivery in an ICU environment.
Supplemental material
Supplemental material
Ethics statements
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References
Footnotes
YSJ and YK contributed equally.
Contributors YSJ and YK: conception and design of study, drafting and critically revising the manuscript. SK: conception and design of study. YSJ and TJK: development of the protocol and manuscript review. SHY: conception and design of study, drafting and critically revising the manuscript, development of the protocol and manuscript review. SHY is responsible for the overall content as the guarantor. All authors approved of the final version of the manuscript. The funder had no involvement in any aspect of the study or publication process.
Funding This research was supported by a grant from the Patient-Centered Clinical Research Coordinating Center (PACEN), funded by the Ministry of Health & Welfare of the Republic of Korea (grant number: RS-2023-KH137917).
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.