Supporting Families in the ICU: The Chaplain Family Project Multicenter RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Effect of the intervention on surrogate anxiety (GAD-7)
研究概览
简要总结
The overarching goal of our work is to test the effect of high-quality spiritual care for ICU family surrogates on outcomes of psychological and spiritual well-being and medical decision making. Our team has developed an approach to high quality spiritual care intervention for ICU surrogates, called the Spiritual Care Assessment and Intervention (SCAI) framework, which is delivered by a chaplain interventionist to ICU surrogates.
详细描述
To prepare for a fully powered, multi-center study, we propose a 2-arm, attention controlled, randomized pilot trial of high-quality spiritual care for 64 surrogates at 2 additional US medical centers.
Specific Aims are:
- To determine the feasibility and acceptability of all aspects of the study, including enrollment, randomization, delivery of the SCAI framework (e.g., chaplain intervention) and attention control conditions, acceptability, and outcome assessments, in preparation for a larger, Stage III effectiveness trial.
- To test the effects of spiritual care on the primary outcome of anxiety (GAD-7) and the secondary outcomes of surrogate spiritual well-being and satisfaction with spiritual care (FACIT-Sp-non-illness version, Satisfaction with Care-Chaplain), and decision making for the patient, including the process of decision making and the medical care received by the patient.
- To study the experience of spiritual care from the perspective of surrogates who are religious and those who are not, those of different faiths, and those who describe themselves as spiritual but not religious.
Because chaplains are common in the ICU this intervention is highly scalable. Results will guide hospital leaders, policy makers and the healthcare team regarding how to deploy chaplains to improve surrogates' psychological and spiritual health and the quality of decisions for critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We will enroll patient/surrogate dyads.
- •Patients will be eligible if:
- •They are age 18 or older at the time of screening.
- •They are judged to lack decisional capacity based on either:
- •a Glasgow Coma Scale (GCS) score of 8 or less; or a GCS of 9-13 with at least one secondary criterion (intubation, sedation, delirium, or noted by clinicians to be unresponsive, comatose or unable to follow commands).
- •* They have an eligible surrogate willing to participate.
- •Surrogates will be eligible if:
- •They are age 18 or older,
- •They are considered the legally authorized representative (LAR) based on prior appointment by the patient or each state's medical consent law.
- •Patient/surrogate dyads will be ineligible if:
- •* They are unable to complete enrollment activities within 96 hours of admission to the ICU.
- •Patients will be ineligible if:
- •They are being discharged from the ICU within 24 hours.
- •They are intubated for surgery but expected to be extubated soon (typically within 24 hours).
- •They are imminently dying or have a planned terminal wean.
- •Surrogates will be ineligible if:
- •*They are unable to complete study procedures in English.
排除标准
- 未提供
研究组 & 干预措施
Control (ICU Guide)
Participants in this arm will participate in meetings with a member of the research team to review an ICU guide.
干预措施: ICU Guide (Behavioral)
Intervention (SCAI Framework)
Participants in this arm will receive the chaplain led intervention of the Spiritual Care Assessment and Intervention (SCAI) framework.
干预措施: Spiritual Care Assessment and Intervention (SCAI) Framework (Behavioral)
结局指标
主要结局
Effect of the intervention on surrogate anxiety (GAD-7)
时间窗: Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital
Generalized Anxiety Disorder- 7 (GAD-7) (7 item inventory of anxiety)- assesses subject's self-reported anxiety for the last two weeks. Scores range from 0-21 0= 'Not at all'; 1= 'Several Days'; 2= 'More than half the days'; 3= 'Nearly every day' Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD.
次要结局
- Effect of the intervention on surrogate spiritual well-being (FACIT-Sp)(Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital)
- Decision making quality (FS-ICU)(Assessed 6-8 weeks after the patient has discharged from the hospital)
- Satisfaction with Spiritual Care (PSI-C)(Assessed 6-8 weeks after the patient has discharged from the hospital)
研究者
Alexia M. Torke
Professor of Medicine
Indiana University