Rapid Response Teams - How and Who? A Randomized Controlled Trial Examining the Composition of the RRT in a General Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- 30-Day Mortality
研究概览
简要总结
This will be an investigator initiated One-sided blinded Randomized Clinical Trial.
The study will examine the composition of the Rapid Response Team (RRT). the investigators will examine to see if a Critical Care Outreach Team (CCOT) consisting of an ICU-Nurse and a general ward physician and nurse are non-inferior to a Medical Emergency Team (MET) consisting of an ICU-Doctor and ICU Nurse as well as a general ward physician and nurse. The randomization will be done using an Analogue randomization sequence using sealed opaque envelopes with central randomization.The experimental intervention will be the CCOT. The statistical analyses will be done on the primary outcomes in the intention to treat population and on the secondary outcomes on an per-protocol basis exempting those with protocol violations.
详细描述
Trial design This trial is an investigator initiated, multi-centre, locally Randomized, one-side blinded trial of Nurse attended vs. Doctor attended RRT.
Randomization The patient will be screened for enrollment prior to the RRT leaving the ICU. A 1:1 randomization will occur at the time of call. The randomization will be with allocation concealment using a centrally randomized sequence at all participating sites. Due to time constraints the investigators will be using an analogue randomization sequence with sealed opaque envelopes. The Randomization sequence will be generated by a person independent of the project using Statistical software (SPSS or other like software) with a binary outcome of 0 or 1, where 0 will equal the control group and 1 will equal the intervention group. An independent group will then package sealed opaque envelopes in coherence with the sequence generated (controls will have blue cards, while interventions will be marked red). The sealed envelopes will be delivered to the primary investigator who will carry the responsibility of distributing these to the participating sites. When a patient is included the nurse will draw an envelope, open it, and sign the card which has been taken out. The local investigator or his/her delegate must on a daily basis collect and register the signed cards.
Blinding The allocation group is to be blinded for the investigators. As it is near impossible to blind the intervention for the clinicians the randomized allocation will not be blinded for the clinicians.
Members of the management committee (MC) will therefore not be involved in the daily clinical decision makings of the included patients. The outcome assessment will be blinded (i.e. registry-based assessment of interventions, evaluations, mortality, outcome and activation reasons). The statistical analyses will be with masked intervention groups i.e. coded as X/Y. And there will be done two conclusions, one defining x as the experimental group, and one assuming the opposite. The Steering Committee will be presented with two abstracts that must be accepted prior to breaking the bond.
If at anytime the investigators find it needed to investigate the results an Data Monitoring and Security Committee (DMSC) the members of the DMSC will remain blinded unless they 1) request unblinding or 2) find that an interim analysis provides strong indication of one intervention being beneficial or harmful.
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
- Double (Investigator, Outcomes Assessor)
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
- •Admitted to any general ward of the hospital AND
- •Aged ≥ 18 years AND
- •In need of RRT attention
排除标准
- •Age < 18
- •Admitted to the delivery ward
- •Admitted to any ward in the anesthetic department
- •High Dependency Unit
- •Post Operation Department
- •Operating Theatre
- •Same Day Admissions - Surgery Ward
- •Not admitted at the time of call
- •Evaluation track in Emergency department (prior to being seen by a doctor)
- •Out-Patient departments
- •X-ray department
- •Any patient who cannot be randomized at the time of call
结局指标
主要结局
30-Day Mortality
时间窗: up to 30 days
Binary outcome measured via the patient Electronic Medical Records
Unexpected Death
时间窗: up to 30 days
Binary outcome measured via the Patient Electronic Medical Records and National Register of deaths in the population. Defined as Any deaths post randomization until discharge or 30 days post randomization without treatment limitation being implemented during or 24 hours after the RRT, and without a "do not attempt resuscitation" order
In-Hospital Cardiac Arrest (IHCA)
时间窗: up to 30 days
Binary outcome measured via the patient Electronic Medical Records: defined as any IHCA post randomization and until discharge or 30 days post randomization
Unplanned Admission to the Intensive Care Unit
时间窗: up to 30 days
Binary outcome measured via the patient Electronic Medical Records. Defined as Admission to the ICU more than 24h Post randomization until discharge or 30 day post randomization
次要结局
- Score To Door Time(Through intervention completion, an average of 4 hours)
- Activation of escape protocol(Through intervention completion, an average of 45 minutes)
- 90-day mortality(90 days)
- Length of Stay(From date of admission until discharged up to 1 year)
- Survival until discharge(From date of admission until the date discharged up to 1 year.)
- Time Spent Bedside(Through intervention completion, an average of 45 minutes)
- Initiation of End of Life Care (EOL)(Maximum 30 days post randomization)