Digitalized Clinical Decision Support for the Prevention of Postoperative Delirium (POD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 845
- 试验地点
- 8
- 主要终点
- Guideline adherence
研究概览
简要总结
The project aims to improve patient safety, reduce barriers to the implementation of current guideline recommendations, reduce workload in clinics, increase efficiency in work processes and close gaps in care. Subprojects regarding delirium are implementes as well.
详细描述
Postoperative delirium (POD) is the most common post-operative complication in the 70+ age group, affecting approximately fifteen percent of elderly patients. POD is characterized by impaired attention, awareness, and cognitive function. Both patients and their families are severely affected by the effects of this condition. While symptoms of POD occur during hospitalization, they have a critical impact on post-hospitalization quality of life, dependency on long-term care, and life expectancy.
The overarching goal of the Digi-POD project consortium is to develop a digital decision support system that makes current evidence-based guideline recommendations for POD machine-readable and allows automated, real-time validation against clinical data.
Sub-projects such as a point prevalence analysis on the incidence of delirium on 2 days at the Charité and a staff survey conducted by Aktionsbündnis Patientensicherheit e.V. in all study centers accompany this study.
Further substudies initiated by Charité Universitätsmedizin Berlin:
Two substudies (one feasibility study and one acceptance study) will be conducted using the prototype of the Clinical Brain Protection (CBP) application in Digi-POD patients at Charité.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study patients:
- •Inclusion Criteria:
- •Age ≥ 70 years
- •Male and female patients
- •Patients who are insured through statutory health insurance
- •Patients capable of giving consent for inclusion: by the patient, preoperatively
- •Patients under guardianship for inclusion: written declaration of consent by guardian
- •Operation (elective)
排除标准
- •Insufficient language skills
- •Moribund patients
- •Study relatives
- •Inclusion Criteria:
- •Age ≥ 18 years
- •Male and female relatives
- •Relatives capable of giving consent for inclusion
- •Exclusion Criteria:
- •Insufficient language skills
- •No consent for data entry
- •Substudy of the Charité - University Berlin:
- •Inclusion criteria:
- •- All inpatients ≥ 18 years of age who have undergone delirium screening with a validated delirium screening instrument
研究组 & 干预措施
Control phase
Control phase: in this phase, all study patients receive the standard therapy of the respective study center.
Intervention phase
In this phase, the intervention with Digi-POD is made available as Clinical Decision Support System. The intervention consists of providing patients, relatives and caregivers with Digi-POD decision support for the prevention of delirium and treatment decisions for delirium in accordance with the recommendations from the guidelines in addition to the standard therapy of the respective study center.
干预措施: Intervention with clinical decision support system (Other)
结局指标
主要结局
Guideline adherence
时间窗: Up to five days
Guideline adherence: proportion of guideline recommendations fulfilled per patient in the first five postoperative days. The guideline adherence rate up to postoperative day 5 (or earlier if the patient has already been discharged) is calculated as a simple division: Number of recommendations fulfilled by number of all recommendations (N=6). A guideline adherence rate of at least 4 out of 6 points (67%) per patient is considered clinically sufficient.
Postperative delirium- free days
时间窗: Up to five days
Number of postoperative delirium- free days within 5 days postoperatively per patient.
次要结局
- Causes of delirium(Up to seven days)
- Changes of Electroencephalography(Participants will be followed up until the end of the operation, an expected average of 60 minutes)
- Blood pressure(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Pulse(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Heart rhythm(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Heart rate(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Oxygen saturation(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Amount of dexmedetomidine(Participants will be followed up until the end of intensive care unit stay, an expected average of 3 days.)
- Therapeutic measures against postoperative delirium (POD)(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Team meetings on postoperative delirium (POD)(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Delirium incidence(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Delirium duration(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Proportion of patients with adequate adherence(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Proportion of patients with good adherence(Up to 7 postoperative days)
- Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.(Up to 7 postoperative days)
- Guideline adherence(Up to 7 postoperative days)
- Number of POD-free days within 7 days(Up to 7 postoperative days)
- Delirium incidence within 7 days(Up to 7 postoperative days)
- Anxiety(Up to 5 postoperative days)
- Pain(Up to 5 postoperative days)
- Depth of sedation(Up to 5 postoperative days)
- Functional performance(Up to 5 postoperative days)
- Concomitant medication(Up to 5 postoperative days)
- Complications(Up to 7 postoperative days)
- Infection status(Up to 7 postoperative days)
- Charlson comorbidity index (CCI)(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Change in cognitive status I(Up to 6 months)
- Change in cognitive status II(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Change in care level for BARMER patients(Up to 6 months)
- Change in utilization of inpatient care(Up to 6 months)
- Change in Patient-Reported Outcomes Measures (PROMs)(Up to 3 months)
- Change in Patient-Reported Experience Measures (PREMs)(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Change in the result from the detailed geriatric assessment and the frailty scoring(Up to 6 months)
- Length of hospital stay(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Length of intensive care unit stay(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Discharge type(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Length of stay in the recovery room(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Duration of surgery(Participants will be followed up until the end of operation, an expected average of 2 hours)
- Duration of anesthesia(Participants will be followed up until the end of operation, an expected average of 2 hours)
- Recommended therapies(Up to 6 months)
- Incidence of Post Intensive Care Syndrome (PICS)(Up to 3 months)
- Social data/Paragraph 21 data(Up to 6 months)
- Social data(Up to 6 months)
- All-cause "mortality"(Up to 6 months)
- Direct cost data(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Follow-up costs(Up to 6 months)
- Utilization of benefits(Up to 6 months)
- Personnel resources during the hospital stay(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Investment costs(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
- Maintenance costs(Participants will be followed up until the end of hospital stay, an expected average of 7 days)
研究者
Claudia Spies
Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)
Charite University, Berlin, Germany