Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors (DANE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 528
- 试验地点
- 8
- 主要终点
- Change in overall cognitive recovery
研究概览
简要总结
This study will evaluate the usefulness of the Urgent and Emergency Surgery (UES) Delirium Recovery Model. It is hypothesized that the cognitive, physical and psychological recovery of older UES delirium survivors will be improved through the use of the DANE Recovery Model. Participants can expect to be on the study for 18 months.
详细描述
This is a multi-site, two-arm, single-blinded randomized controlled clinical trial to evaluate the efficacy of the DANE Recovery Model to improve the cognitive, physical and psychological recovery of older UES delirium survivors. At or near the time of discharge, enrolled participants will be randomized to receive the DANE Recovery Model or usual care. The hypothesis is that, after 18 months, older UES delirium survivors who are randomized to the DANE Recovery Model will experience more favorable cognitive, physical and psychological recovery in comparison to those randomized to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult age 65 years and older
- •Admitted to one of the participating hospitals
- •Undergone an abdominal orthopedic, skin, or vascular surgery in an emergency or unplanned fashion
- •English-speaking
- •Able to provide consent or have a legally authorized representative to provide consent
- •Access to a telephone or an internet connected computer or smart device
- •Discharged to home or sub-acute rehabilitation
- •At least one episode of delirium or subsyndromal delirium, i.e. screen positive on at least one out of the four items on the Confusion Assessment Method-ICU (CAM-ICU) in the period prior to discharge from acute care.
排除标准
- •A self-reported diagnosis of cancer with short life expectancy
- •A history of dementing illnesses and other neurodegenerative disease such as Alzheimer's disease (AD), Parkinson disease, or vascular dementia, or current prescription of anti-dementia medication, or ruled out by Functional Activities Questionnaire (FAQ) score defining dementia; a history of significant traumatic brain injury
- •Acute or subacute neurologic deficit expected to prevent independent living after hospital discharge, e.g., a history of a significant traumatic brain injury
- •Have any spinal cord injury with persistent neurologic deficit at the time of study enrollment
- •Incarcerated or homeless at the time of study enrollment
- •Acquired neurologic injury (stroke, traumatic brain injury, cerebral edema/swelling, anoxic brain injury, or any other acute/subacute severe neurologic deficit) as the admitting diagnosis or a new event during the course of hospitalization (confirmed by EMR)
- •A history of bipolar disorder or schizophrenia (confirmed by EMR)
研究组 & 干预措施
DANE Recovery Model
The delivery of the model will occur in five phases that correspond to the known stages of recovery after surgery. During the acute stage (0 - 1 month after surgery), participants will undergo the initial case review and two initial virtual visits, and the development of the recovery care plan. During the recovery (2 - 6 months after surgery) and maintenance (7-12 months after surgery) stages, the participants will undergo the interaction phase of the DANE Recovery Model.
干预措施: DANE Recovery Program (Other)
Usual Care
Participants will receive the usual rehabilitation and post-operative care.
干预措施: Questionnaires (Other)
Usual Care
Participants will receive the usual rehabilitation and post-operative care.
干预措施: DANE Recovery Program (Other)
结局指标
主要结局
Change in overall cognitive recovery
时间窗: Baseline, 6 months, 12 months, and 18 months
Change in score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) cognitive screening assessment. The measure consists of 12 subtests that contribute to a total score and Index scores across five domains: Immediate Memory, Visuospatial-Constructional, Language, Attention, and Delayed Memory. Index scores are converted to age-based standard scores (Mean = 100, Standard Deviation = 15)
次要结局
- Short Physical Performance Battery (SPPB)(Baseline, 6 months, 12 months, and 18 months)
- Change in overall physical recovery(Baseline, 6 months, 12 months, and 18 months)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, 6 months, 12 months, and 18 months)
- General Anxiety Disorder-7 (GAD-7) .(Baseline, 6 months, 12 months, and 18 months)