Evaluation of the Clinical Impact of Different Telemedicine Practices in Intensive Care Units: a Stepped-wedge Cluster Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22,000
- 试验地点
- 1
- 主要终点
- Intensive Care Unit Length of Stay
研究概览
简要总结
The objective of this study is to assess whether an intervention package via telemedicine consisting of daily multidisciplinary rounds with a specialist in intensive care medicine, an intervention package provided by a specialized multiprofessional team (nursing, physical therapy and clinical pharmacy) and a management intervention package, focused on quality and safety, reduces the length of stay in ICU patients in Brazil. Our hypothesis is that the intervention package via telemedicine has the potential to decrease the length of stay in ICU patients in Brazil.
The study provides for the implementation of three interventions in association via telemedicine.
- Daily multidisciplinary rounds conducted by a physician specialized in intensive care medicine
- Intervention package by specialized multidisciplinary team (nursing, physiotherapy and clinical pharmacy).
- Management intervention package (quality and safety).
The main questions it aims to answer are:
- Length of stay in ICU
- ICU mortality.
- In-hospital mortality.
- Ventilator-free days during the first 28 days.
- ICU readmission within 48 hours.
- Early reintubation (<48h after elective extubation).
- Ventilator-associated events.
- Accidental extubation rate.
- Patient Mobilization Density.
- Adherence to maintaining the head-of-bed elevation.
- Adequate prevention of venous thromboembolism.
- Rate of patient-days under adequate sedation.
- Rate of patients-days with oral or enteral nutrition.
- Rate of patients with adequate glycemic control.
- Rate of patients-days within normoxemia.
- Rate of central venous catheter use.
- Central venous catheter dwell time.
- Rate of indwelling urinary catheter use.
- Indwelling urinary catheter dwell time.
- Standard resource use.
- Standardized mortality rate.
详细描述
BACKGROUND:
ICU beds represent a scarce and high cost resource. This scenario is aggravated by the scarcity and heterogeneous distribution of specialists in intensive care medicine in Brazil. Telemedicine is an innovative and promising technology, with the possibility of making the daily multidisciplinary round accessible with the presence of intensive care medicine specialists throughout the national territory. In a previous study (Telescope Trial I), it was demonstrated that daily multidisciplinary round conducted via telemedicine by a remotely located medical specialist is a safe and feasible practice. However, little is known about different modalities of telemedicine care in the ICU environment, more specifically, about the impact of interventions performed by a multidisciplinary team (non-medical) and management interventions (quality and safety).
SAMPLE SIZE CALCULATION:
A total sample size of 18,750 to 25,000 patients will be considered to detect a reduction in the length of stay in the ICU on a logarithmic scale of 0.1479 (equivalent to a 1.1-day reduction compared to the baseline), resulting from the intervention package with a significance level of 5% and a minimum power of 95%. This variation in total sample size is due to different estimates of patients per period in the 25 Brazilian ICUs in question. It is estimated that there will be a variation of 30 to 40 patients recruited per month per ICU.
PRIMARY OUTCOME:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
For technical reasons, it is impossible to perform blinding for patients, health care staff, professionals involved in patient care, and data collectors in the ICUs participating in the study.
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
- •for Intensive care units:
- •Intensive care units from public or philanthropic hospitals.
- •ICUs with a minimum of 7 and a maximum of 20 beds.
- •Intensive care units with physician and nurses available 24 hours a day and physiotherapist available at least ≥ 18 hours a day.
排除标准
- •for Intensive care units:
- •Intensive care units with structured multidisciplinary round more than three times a week conducted by an intensive care physician (certified), documented in the medical record, with a fixed duration (>5 min / patient), using some supporting tool (checklist or standard form), goal oriented, based on established protocols, including all the patients admitted to the ICU.
- •Intensive care units already doing audit and feedback with specific planning.
- •Dedicated coronary care units/cardiac intensive care units or other specialized units (cardiac surgery, neurological, burned patients).
- •Step-down units or semi-intensive cardiac care unit.
- •Intensive care units without availability of substitute renal therapy.
- •ICU coordinator specialist in intensive care medicine and management training (MBA in Health Management or equivalent).
- •Inclusion Criteria for patients:
- •Adult patients (≥ 18 years old).
- •Exclusion Criteria for patients:
- •Admission for other reasons than medical (e.g., judicial cause, legal reasons, safety reasons).
- •Previously included in the TELESCOPE II trial (for the primary outcome analysis).
研究组 & 干预措施
Sequence 1
Sequence 1 will consist of a 3-month control period, followed by a 3-month transition period, and finally, a 19-month intervention period. The total duration of sequence 1 will be 25 months.
干预措施: Intervention period (Other)
Sequence 2
Sequence 2 will consist of a 7-month control period, followed by a 3-month transition period, and finally, a 15-month intervention period. The total duration of sequence 2 will be 25 months.
干预措施: Intervention period (Other)
Sequence 3
Sequence 3 will consist of a 11-month control period, followed by a 3-month transition period, and finally, a 9-month intervention period. The total duration of sequence 3 will be 25 months.
干预措施: Intervention period (Other)
Sequence 4
Sequence 4 will consist of a 15-month control period, followed by a 3-month transition period, and finally, a 7-month intervention period. The total duration of sequence 4 will be 25 months.
干预措施: Intervention period (Other)
Sequence 5
Sequence 5 will consist of a 19-month control period, followed by a 3-month transition period, and finally, a 3-month intervention period. The total duration of sequence 5 will be 25 months.
干预措施: Intervention period (Other)
结局指标
主要结局
Intensive Care Unit Length of Stay
时间窗: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Defined as the time interval in hours between patients' ICU admission and the moment of ICU physical discharge times (i.e., transfer to another care facility or another hospital) or ICU death, as defined by the hospital's system date and time. Date and time will be entered by the health care worker responsible for data collection. ICU LOS will be derived in 24 hours periods with decimal place.
次要结局
- Ventilator-free days at day 28(28 Days)
- Standard mortality rate(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
- Patient Mobilization Density(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
- Mortality in the Intensive Care Unit(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
- Standard resource use(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
- Ventilator-associated events(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)