跳至主要内容
临床试验/NCT05221697
NCT05221697
进行中(未招募)
不适用

Effect of an Electronic Alert Management System Using Caregivers' Observations and Machine Learning Algorithm to Reduce the Use of Emergency Department Visits and Unplanned Hospitalizations Among Older People

Presage2 个研究点 分布在 1 个国家目标入组 800 人2020年9月1日
适应症Emergencies

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Emergencies
发起方
Presage
入组人数
800
试验地点
2
主要终点
Event-free survival (EFS)
状态
进行中(未招募)
最后更新
2年前

概览

简要总结

Development, validation and impact of an alert management system using social workers' observations and machine learning algorithms to predict 7-to-14-day alerts for the risk of Emergency Department (ED) Visit and unplanned hospitalization.

Multi-center trial implementation of electronic Home Care Aides-reported outcomes measure system among patients, frail adults >= 65 years living at home and receiving assistance from home care aides (HCA).

详细描述

On a weekly basis, after home visit, HCAs reported on participants' functional status using a smartphone application that recorded 23 functional items about each participant (e.g., ability to stand, move, eat, mood, loneliness). Predictive system using Machine learning techniques (i.e., leveraging random forest predictors) was developed and generated 7 to 14-day predictive alerts for the risk of ED visit to nurses. This questionnaire focused on functional and clinical autonomy (ie, activities of daily life), possible medical symptoms (eg, fatigue, falls, and pain), changes in behavior (eg, recognition and aggressiveness), and communication with the HA or their surroundings. This questionnaire is composed of very simple and easy-to-understand questions, giving a global view of the person's condition. For each of the 23 questions, a yes/no answer was requested. Data recorded by HAs were sent in real time to a secure server to be analyzed by our machine learning algorithm, which predicted the risk level and displayed it on a web-based secure medical device called PRESAGE CARE, which is CE marked. Particularly, when the algorithm predicted a high-risk level, an alert was displayed in the form of a notification on the screen to the coordinating nurse of the health care network center of the district. This risk notification was accompanied by information about recent changes in the patients' functional status, identified from the HAs' records, to assist the coordinating nurse in interacting with family caregiver and other health professionals. In the event of an alert, the coordinating nurse called the family caregiver to inquire about recent changes in the patient's health condition and for doubt removal and could then decide to ask for a health intervention according to a health intervention model developed before the start of the study. In brief, this alert-triggered health intervention (ATHI) consisted of calling the patient's nurse (if the patient had regular home visits of a nurse) or the patient's general practitioner and informing them of a worsening of the patient's functional status and a potential risk of an ED visit or unplanned hospitalization in the next few days according to the eHealth system algorithm. This model of ATHI had been presented and approved by the Agences Régionales de Santé of the regions involved in our study

注册库
clinicaltrials.gov
开始日期
2020年9月1日
结束日期
2024年6月30日
最后更新
2年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Presage
责任方
Sponsor

入排标准

入选标准

  • age of 75 yo mini
  • receiving the help of a social worker
  • patient should give their consent
  • patient should had seen their primary care professional within the past 12 months

排除标准

  • People with severe dependence (French national instrument, which stratifies dependency level from group iso-resources (GIR) : 1 (very severe dependency) and 2 (severe dependency)

结局指标

主要结局

Event-free survival (EFS)

时间窗: through study completion, an average of 1 year

Comparison average Time for first adverse event between intervention and control groups. P values \<.05 will be considered statistically significant.

Impact on older adults and relatives' quality of life (European Quality of Life 5 Dimensions and 3 Lines scale)

时间窗: through study completion, an average of 1 year

Comparison of the average score of EQ5D-3L quality of life scale (European Quality of Life 5 Dimensions and 3 Lines) between intervention and control groups. P values \<.05 will be considered statistically significant.

Unplanned Hospitalization rate

时间窗: through study completion, an average of 1 year

Comparison between unplanned hospitalization ratio from 2 randomized groups (intervention and control arms). P values \<.05 will be considered statistically significant.

Cost-effectiveness

时间窗: through study completion, an average of 1 year

Incremental cost-effectiveness ratio (ICER), QALY. Willingness-to-pay thresholds of €30,000 per quality-adjusted life year (QALY) and €90,000 per QALY were used to define a very cost-effective and cost-effective strategy, respectively

次要结局

  • Intervention rate(through study completion, an average of 1 year)
  • Impact on Professional' Relationship and coordination(through study completion, an average of 1 year)
  • Impact on users : time needed to complete questionnaire(through study completion, an average of 1 year)
  • Intervention time(through study completion, an average of 1 year)
  • Time needed to analysis patient statut(through study completion, an average of 1 year)
  • Impact on quality of care(through study completion, an average of 1 year)

研究点 (2)

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