A Feasibility Study Protocol for Implementing Consultation-based Palliative Care Services to Provide High-quality Palliative Care to Families of Critically Ill Patients in Intensive Care Units: A Single-arm Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of Applying Consultation-Based High-Quality Palliative Care
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both patients and surrogates must meet the inclusion criteria and not fall under any
排除标准
- •[Inclusion Criteria]
- •Diagnosis of sudden and severe acute brain injury due to at least one of the following etiologies: vascular, traumatic, metabolic, toxic, infectious, or anoxic AND
- •Glasgow Coma Scale score of 3-8 for at least 24 hours after the patient's admission AND
- •Unable to express themselves verbally or otherwise
- •Diagnosis of advanced stage organ failure (any of the following)
- •Chronic lung disease requiring long-term oxygen therapy or mechanical ventilation
- •Decompensated liver cirrhosis
- •Chronic heart failure with NYHA class III or IV
- •Progressive neurological disease with a modified Rankin score of 3-5 (e.g., dementia, Parkinson's disease, and amyotrophic lateral sclerosis)
- •Three or more chronic comorbidities causing limitations in activities of daily living (ADL) AND
- •APACHE II score ≥ 14 at the time of screening AND
- •ICU stay of 7 days or more
- •Surrogates:
- •Family caregiver of a patient who meets the inclusion criteria (Family: defined as the patient's spouse, lineal ascendants and descendants within two degrees of kinship and their spouses, siblings and their spouses, and relatives within eight degrees of kinship and their spouses)
- •Aged 19 or older
- •Willing and able to provide consent for participation in the study
- •[Exclusion Criteria]
- •Under 19 years of age
- •Unable to speak, understand, or read Korean
- •Refusal of palliative care consultation
- •Referred to palliative care prior to study enrollment
- •Within 48 hours of ICU admission
- •Presence of active cancer under treatment within 6 months prior to ICU admission
- •Care goals set to "comfort care" at the time of study enrollment
- •Death expected within 48 hours at the time of study enrollment
- •Lack of capacity to participate in the study without an appropriate surrogate
- •Surrogates:
- •Under 19 years of age
- •Unable to speak, understand, or read Korean
- •Determined by a physician to be in extremely poor health, making participation in the study infeasible
- •Refusal of palliative care consultation
研究组 & 干预措施
Critically ill patients requiring ICU admission and their surrogates
Participants receive high-quality palliative care through consultation-based palliative care services in addition to standard critical care.
干预措施: High-quality palliative care through consultation-based palliative care services in the ICU (Behavioral)
结局指标
主要结局
Feasibility of Applying Consultation-Based High-Quality Palliative Care
时间窗: 1 day (at discharge)
Proportion of eligible contacts who consented and participated in the study, palliative care family counseling rate, and study completion rate.
次要结局
- Surrogates' Satisfaction with the Intervention Services(Within one week after the final consultation)
- Change in Surrogates' Decisional Self-Efficacy before and after the Intervention(Pre-post comparison (baseline vs. within one week after consultation))
- Change in Surrogates' Emotional State before and after the Intervention(Pre-post comparison (baseline vs. within one week after consultation))
- 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))
- Length of Hospital Stay(1 day (at discharge))
- Survival to Discharge Rate(1 day (at discharge))
- Change in Surrogates' Decisional Conflict before and after the Intervention(Pre-post comparison (baseline vs. within one week after consultation))
- 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))
- Days of Symptom Relief Treatments received in the ICU(1 day (at discharge))
- Proportion of Patients receiving Symptom Relief Treatments During the ICU stay(1 day (at discharge))
- Data Collection Completion Rate(Within three months after the final consultation)
- Use of Symptom Relief Treatments within 48 Hours before Death(1 day (at discharge))
- Time Taken to Recruit Patients(Within the first year of study initiation)
- Use of Life-Sustaining Procedures within 48 Hours before Death(1 day (at discharge))
研究者
Shin Hye Yoo
Assistant Professor
Seoul National University Hospital