Use of a Novel Digital Therapeutic Intervention for the Management of Delirium in the Acute Care Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Agitation scores
研究概览
简要总结
Delirium is a condition of fluctuating confusion and agitation that affects as many as 80% of patients in critical care. Hyperactive delirium consumes a significant amount of clinical attention and resources due to the associated psychomotor agitation. Patients can become aggressive or combative putting both themselves and healthcare workers at risk of harm. Delirium has been linked to an increased risk of death and poor overall outcomes. Management largely relies on the use of potentially toxic medications and physical restraints despite limited proof of success of these interventions. Our research group will study the use of a novel interactive digital therapeutic behavior modification platform aimed at reducing anxiety and agitation associated with hyperactive delirium. We hypothesize that Use of the Mindful Garden behavioral modification platform will result in normalization of agitation and delirium scores when used for the management of delirium associated agitation in the adult delirious acute care population compared to standard care alone.
详细描述
Mindful Garden is a digital behavior modification platform that utilizes screen based delivery systems and sensor technologies. Mindful Garden delivers real 2-dimensional nature video layered with hyper-real 3-dimensional animations of growing and receding flowers and butterflies in flight which aims to reduce anxiety and agitation in the delirious critical care population. In doing so, normalization of agitation and delirium scores may be achieved as well as a reduction in reliance on pharmacological interventions and the use of physical restraints, which have been linked to adverse outcomes and significant side effects.
Participants with a diagnosis of hyperactive delirium in acute care inpatient units will be randomized to receive 4 hours of exposure to the MG platform in addition to standard care or to the control arm of monitoring with standard care only for the same time period.
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 (Outcomes Assessor)
盲法说明
data will be blinded for analysis but the study is open label due to the nature of the intervention
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
- •Adult (age >18yrs)
- •Admitted to the Royal Columbian Hospital
- •RASS +1 or greater for 2 assessments 1 hour apart within the 24-hour period directly prior to study enrollment and persisting at the time of enrollment
- •Demonstrated incidence of at least 2 PRN medication events for the management of delirium-associated agitation in the preceding 24 hours and/or infusion of psycho- active medication for the management of delirium (eg: dexmeditomodine)
- •ICDSC greater than or equal to 4 at time of enrollment or CAM positive
排除标准
- •Planned procedure or test that precludes participation in the full 4-hour study session
- •Unable to see (visual impairment such as documented blindness, ongoing inability to keep eyes open or documented or assessed inability to focus, track or maintain visual contact for extended periods as determined by recruitment personnel)
- •Significant uncontrolled pain with a Verbal Pain scale of 5/10 or greater or a Clinical Pain Observation Tool >4 despite intervention at the time of enrollment.
- •RASS of 0 to -5 at study enrollment indicating patient is awake and calm or sedated
- •Refusal for participation by the participant's responsible physician or request to not retain data by participants substitute decision maker
- •Currently enrolled in any other research study involving drugs or devices which could impact on the outcomes of interest, as evaluated by the Principal Investigator
结局指标
主要结局
Agitation scores
时间窗: 5 hours
Richmond Agitation Sedation Score is a validated and standardized scoring system ranging from -5 (deeply sedated) to 0 (awake and calm) to +4 (combative). Scores are measured hourly from study start, one hour post intervention and at the start of the following nursing shift.
次要结局
- Movement Count Average(4 Hours)
- Use of unscheduled medications for the management of delirium associated agitation(4 hours)
- heart rate variability(6 hours)
- Delirium Scores(4 hours)
- Richmond Agitation Sedation Scale of zero(4 hours)
- Physiological data(4 hours)
- Physical Restraint Use(4 hours)
- Incidence of Unplanned Line removal(4 hours)
- PRN medication use in the 2 hours post study(2 hours)