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
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.
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
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