Rapid Response Teams - How and Who? — RRT-Comp  

Intensive Care Units Clinical Trial

Official title: Rapid Response Teams - How and Who? A Randomized Controlled Trial Examining the Composition of the RRT in a General Hospital

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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.

Participant timeline The investigators will strive to enroll all patients fulfilling the inclusion criteria. Patients will receive either the experimental intervention of an ICU-Nurse attending the RRT, or the control of a Nurse and Doctor from the ICU attending the RRT. They will be followed up 30 days after RRT-event as well as 90- days post randomization. If another RRT-event occurs, within the same admission and within 30 days, another randomization will be performed, however the patient will only be included in the mortality comparison from the first randomization. If another RRT-event occurs within a new admission and within 30-days, the patient will receive another randomization however the patient will only be included in the mortality comparison from the first randomization. If another RRT-event occurs within a new admission after 30 days post randomization, the patient will receive a new randomization and will also be included in the mortality analysis twice.

Trial interventions Experimental intervention To ensure no dropout of data only MET-events where a MET-record is entered in the Electronic Medical Record (EMR) will be included.

The experimental intervention will be a MET-event attended only by an Intensive Care Unit Nurse, the team being led by the ward physician who is also responsible for treatment, even if this doctor is a junior doctor. All departments will be required to have a ward-physician attending a T-event in the trial period.

The ICU-nurse will be required to fill out an entry regarding the MET-event in the patients EMR, where details regarding the call may be registered Control intervention The control intervention will be standardized MET with both ICU doctor and ICU Nurse attending the patient. The ICU doctor will be team leader and the ward physician will be responsible for treatment as always.

The ICU doctor will be required to fill out an entry regarding the MET-event in the patients EMR, where details regarding the call may be registered Data collection Method Data will be obtained from the participants hospital files and national/regional/hospital registers (source data as defined per site, region and country) and by participant survey / interview and entered in the web-based REDCap database by trial investigators or their delegates. For participants transferred from a trial site to a non-trial site, data related to the outcomes will be collected according to national practice i.e. investigator contact to the relevant site or health-care registers.

Baseline variables are:

• Age

• Sex

• Time and Date of admission to hospital

• If applicable Time and Date of admission to ICU

• Time and Date of discharge

• Ward of RRT event

• Specialty responsible for the patient

• Admission cause ;

Related Conditions & MeSH terms

• Early Warning Score
• Hospital Rapid Response Team
• Intensive Care Units

• NCT number: NCT04507737
• Study type: Interventional
• Source: Nordsjaellands Hospital
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Completion date: June 2026