Chaplain Family Project Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 4
- 主要终点
- Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge
研究概览
简要总结
Our research team has designed a chaplain delivered intervention focused on surrogate decision makers for hospitalized adults in the ICU. In this study, surrogates will complete an enrollment interview with research staff, including the completion of anxiety screening (GAD-7). Based on their score the surrogate will be put into one of two groups, and then randomized to either the control or intervention group. Control group members will receive usual care, while intervention group members will meet with our study chaplain, who will provide the SCAI (Spiritual Care Assessment and Intervention) framework.
详细描述
Unmet spiritual needs may have at least two negative consequences for surrogates. First, they may have high levels of spiritual distress, an important aspect of the surrogate's well-being. Second, surrogates include their religious and spiritual beliefs when making serious medical decisions . Therefore unmet spiritual needs may have a negative effect on the surrogate's ability to make good decisions for the patient, especially when facing extremely distressful decisions such as whether to continue life sustaining treatment or enroll in hospice.
The specific aims of this proposed study are:
- To determine the effect of the spiritual care intervention on psychological well-being for family surrogates at 3 months post discharge, including anxiety (primary outcome: GAD-7), depression (PHQ-9), Posttraumatic stress (IES-R), and overall distress.
- To determine the effect of the spiritual care intervention on spiritual well-being for family surrogates, (FACIT-SP- non-illness) and on religious coping (Brief RCOPE positive and negative).
- To determine the effects of the spiritual care intervention on other aspects of the surrogates' experience, including satisfaction with spiritual care (Patient Satisfaction Instrument--Chaplaincy) communication (FICS), overall satisfaction with the hospital stay (Picker single item) and decision conflict (DCS).
- To determine the effect of the intervention on treatment at the end of life (life sustaining treatments and hospice utilization) for patients who die in the hospital.
- To determine differences in outcomes between the intervention group, who will receive our intervention, and the control group, who will receive the usual care provided by the hospital chaplaincy service.
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)
盲法说明
Research staff conducting interviews with study participants will be masked to study group allocation, until all outcome assessments for that participant have been completed.
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
- •Cognitive Requirements
- •Patient is not decisional due to:
- •Intubation (other than surgery- see exclusion criteria below)
- •Unresponsive
- •otherwise unable to communicate (AMS, dementia, delirium, etc.)
- •Decision Support Requirements
- •Patient has a qualified surrogate decision maker
排除标准
- •Intubated for surgery and expected to be extubated within 24 hours
- •Imminently dying as evidenced by patient notes
- •Patient and/or family have a care contract or other restriction due to complicated or volatile situation
- •Patient is a prisoner
- •Patient is being followed by Adult Protective Services (APS)
- •Patient meets cognitive criteria but does not have a qualified surrogate decision maker
结局指标
主要结局
Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge
时间窗: Assessed at enrollment and again 6-8 weeks after hospital discharge
GAD-7 (7 item inventory of anxiety)
次要结局
- Change in overall distress from baseline enrollment interview to 6-8 weeks post patient discharge(Assessed at enrollment and again 6-8 weeks after hospital discharge)
- Change in depression from baseline enrollment interview to 6-8 weeks post patient discharge(Assessed at enrollment and again 6-8 weeks after hospital discharge)
- Presence of post traumatic stress at 6-8 weeks post patient discharge(Assessed 6-8 weeks after hospital discharge)
研究者
Alexia M. Torke
Associate Professor of Medicine
Indiana University