Feasibility Study on Implementing Consultation-based High-quality Palliative Care Services in Intensive Care Units
- Conditions
- Critical Illness
- Interventions
- Behavioral: High-quality palliative care through consultation-based palliative care services in the ICU
- Registration Number
- NCT06490835
- Lead Sponsor
- Seoul National University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Critically ill patients requiring ICU admission and their surrogates High-quality palliative care through consultation-based palliative care services in the ICU Participants receive high-quality palliative care through consultation-based palliative care services in addition to standard critical care.
- Primary Outcome Measures
Name Time Method Feasibility of Applying Consultation-Based High-Quality Palliative Care 1 day (at discharge) Proportion of eligible contacts who consented and participated in the study, palliative care family counseling rate, and study completion rate.
- Secondary Outcome Measures
Name Time Method Change in Surrogates' Decisional Self-Efficacy before and after the Intervention Pre-post comparison (baseline vs. within one week after consultation) 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.
Change in Surrogates' Emotional State before and after the Intervention Pre-post comparison (baseline vs. within one week after consultation) 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.
Level of Patient- and Family-Centered Care Experienced by Surrogates after the Intervention Follow-up (within one week after consultation and one month after consultation; up to three months after the final consultation for deceased patients) 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.
Surrogates' Satisfaction with the Intervention Services Within one week after the final consultation 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)
Length of Hospital Stay 1 day (at discharge) Length of ICU stay and overall hospital stay
Survival to Discharge Rate 1 day (at discharge) Vital status at discharge
Change in Surrogates' Decisional Conflict before and after the Intervention Pre-post comparison (baseline vs. within one week after consultation) 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.
Surrogates' Decision Regret after the Intervention Follow-up (within one week after consultation and one month after consultation; up to three months after the final consultation for deceased patients) 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.
Days of Symptom Relief Treatments received in the ICU 1 day (at discharge) Number of days receiving comfort-focused care (opioids and/or antipsychotics) during the ICU stay, based on a retrospective review of medical records
Proportion of Patients receiving Symptom Relief Treatments During the ICU stay 1 day (at discharge) 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
Data Collection Completion Rate Within three months after the final consultation Proportion of data collected at each time point exceeding 90%
Use of Symptom Relief Treatments within 48 Hours before Death 1 day (at discharge) 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.
Time Taken to Recruit Patients Within the first year of study initiation Time interval between enrollment of the first and tenth patients
Use of Life-Sustaining Procedures within 48 Hours before Death 1 day (at discharge) 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.
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, N/A (Not Applicable), Korea, Republic of