Feasibility Study on Implementing Consultation-based High-quality Palliative Care Services in Intensive Care Units
NCT Number: NCT06490835
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Critical Illness
Interventions: BEHAVIORAL: High-quality palliative care through consultation-based palliative care services in the ICU
Sponsor: Seoul National University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-19
Completion Date: 2025-12-31
Locations: Seoul National University Hospital, Seoul, N/A (Not Applicable), 03080, Korea, Republic of

Summary:
Critically ill patients in intensive care units (ICUs) receive life-sustaining treatments aimed at restoring or maintaining organ function. ICU admission often involves substantial physical and existential pressures that can burden patients, their families, and surrogates. Multidisciplinary palliative care support can help alleviate potential causes of suffering. Twenty patients admitted to the ICUs at Seoul National University Hospital, diagnosed with sudden and severe acute brain injury or progressive organ failure, along with their surrogates, will be enrolled in the study. This study aims to assess the feasibility of applying consultation-based palliative care services to provide higher quality palliative care for critically ill patients with acute illnesses and their families facing poor prognoses upon ICU admission. Additionally, the study seeks to determine whether providing such palliative care services can help better respect the patient's values and goals, reduce communication conflicts, alleviate family caregivers' anxiety and depression, and enhance satisfaction with critical care.

Primary Outcome Measures: Feasibility of Applying Consultation-Based High-Quality Palliative Care, Proportion of eligible contacts who consented and participated in the study, palliative care family counseling rate, and study completion rate., 1 day (at discharge)
Secondary Outcome Measures: Change in Surrogates' Decisional Conflict before and after the Intervention, The Decisional Conflict Scale (DCS) is a validated tool designed to evaluate personal uncertainty when making healthcare decisions, including modifiable factors that contribute to such uncertainty and the overall quality of the decision. It consists of 16 questions, each rated on a 5-point scale from "strongly agree" (1) to "strongly disagree" (5). Scores range from 16 to 80, with higher scores reflecting greater uncertainty and less favorable outcomes., Pre-post comparison (baseline vs. within one week after consultation)|Change in Surrogates' Decisional Self-Efficacy before and after the Intervention, The Decisional Self-Efficacy Scale (DSES) evaluates an individual's self-confidence or belief in their decision-making abilities, including the ability to participate in shared decision making. The scale consists of 11 items, each rated on a five-point Likert scale from "0" (no confidence) to "4" (very confident). To determine the total score, the sum of the item scores is divided by 11 and then multiplied by 25. Scores range between 0 and 100, with higher scores indicating higher levels of decision-making self-efficacy., Pre-post comparison (baseline vs. within one week after consultation)|Change in Surrogates' Emotional State before and after the Intervention, The Hospital Anxiety and Depression Scale (HADS) is a questionnaire consisting of fourteen items. Seven items focus on anxiety, while the other seven address depression. Scores for each subscale range from 0 to 21, with higher scores reflecting higher levels of anxiety or depression., Pre-post comparison (baseline vs. within one week after consultation)|Surrogates' Decision Regret after the Intervention, The Decision Regret Scale (DRS) is a 5-item, 5-point Likert-type self-report measure used to assess distress or remorse following a healthcare decision. Items are rated from 1 ("strongly agree") to 5 ("strongly disagree"), with two items (2 and 4) phrased negatively. To calculate the total score, the negatively phrased items are first reversed, then the mean of all five items is computed. This mean is rescaled from 0 to 100 by subtracting 1 and multiplying by 25. A score of 0 represents no regret, while 100 indicates a high level of regret., Follow-up (within one week after consultation and one month after consultation; up to three months after the final consultation for deceased patients)|Level of Patient- and Family-Centered Care Experienced by Surrogates after the Intervention, The Modified Patient Perception of Patient-Centeredness (PPPC) scale, utilized by surrogates, consists of 12 items. The scores range from 0 to 100, with higher scores indicating a higher level of patient-centered care., Follow-up (within one week after consultation and one month after consultation; up to three months after the final consultation for deceased patients)|Surrogates' Satisfaction with the Intervention Services, Overall satisfaction with ICU palliative care, family counseling satisfaction, consultation satisfaction, and family meeting satisfaction, assessed on a 5-point scale (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied), Within one week after the final consultation|Length of Hospital Stay, Length of ICU stay and overall hospital stay, 1 day (at discharge)|Survival to Discharge Rate, Vital status at discharge, 1 day (at discharge)|Days of Symptom Relief Treatments received in the ICU, Number of days receiving comfort-focused care (opioids and/or antipsychotics) during the ICU stay, based on a retrospective review of medical records, 1 day (at discharge)|Proportion of Patients receiving Symptom Relief Treatments During the ICU stay, The percentage of the total study population who received comfort-focused care (opioids and/or antipsychotics) during the ICU stay, based on a retrospective review of medical records, 1 day (at discharge)|Use of Life-Sustaining Procedures within 48 Hours before Death, We assessed the life-sustaining procedures administered during the end-of-life (EOL) stage using seven indicators: cardiopulmonary resuscitation (CPR), mechanical ventilation, continuous renal replacement therapy, surgery, vasopressors, extracorporeal membrane oxygenation (ECMO), and high-flow oxygen (HFO2). The percentage of the total study population that received each procedure within the last 48 hours of life was measured., 1 day (at discharge)|Use of Symptom Relief Treatments within 48 Hours before Death, Administration of opioid analgesics and/or antipsychotic medications within the final 48 hours of life was regarded as receiving end-of-life comfort care. We analyzed the percentage of the total study population that received opioid analgesics and/or antipsychotic medications during the last 48 hours of life., 1 day (at discharge)|Data Collection Completion Rate, Proportion of data collected at each time point exceeding 90%, Within three months after the final consultation|Time Taken to Recruit Patients, Time interval between enrollment of the first and tenth patients, Within the first year of study initiation
Other Outcome Measures: Qualitative Evaluation of Intervention Feasibility and Satisfaction, Evaluation of feasibility and satisfaction through semi-structured, one-on-one interviews with surrogates, Within three months after the final consultation|Additional Analysis of Surrogates' Emotional State Changes before and after the Intervention, The Hospital Anxiety and Depression Scale (HADS) comprises fourteen questionnaire items, with seven dedicated to anxiety and the remaining seven to depression. Each subscale score ranges from 0 to 21, where higher scores indicate greater levels of anxiety or depression., One month after the final consultation (within three months for deceased patients)