Clinical trial NCT04507737: Rapid Response Teams - How and Who?
Official title: Rapid Response Teams - How and Who? A Randomized Controlled Trial Examining the Composition of the RRT in a General Hospital
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hospital Rapid Response Team
Early Warning Score
Intensive Care Units
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Admitted to any general ward of the hospital AND
* Aged ≥ 18 years AND
* In need of RRT attention

Exclusion Criteria:

* Age \< 18
* Admitted to the delivery ward
* Admitted to any ward in the anesthetic department

  * ICU
  * 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

Primary outcomes:
measure: 30-Day Mortality
timeFrame: up to 30 days
measure: In-Hospital Cardiac Arrest (IHCA)
timeFrame: up to 30 days
measure: Unplanned Admission to the Intensive Care Unit
timeFrame: up to 30 days
measure: Unexpected Death
timeFrame: up to 30 days
Secondary outcomes:
measure: Activation of escape protocol
timeFrame: Through intervention completion, an average of 45 minutes
measure: 90-day mortality
timeFrame: 90 days
measure: Time Spent Bedside
timeFrame: Through intervention completion, an average of 45 minutes
measure: Initiation of End of Life Care (EOL)
timeFrame: Maximum 30 days post randomization
measure: Score To Door Time
timeFrame: Through intervention completion, an average of 4 hours
measure: Survival until discharge
timeFrame: From date of admission until the date discharged up to 1 year.
measure: Length of Stay
timeFrame: From date of admission until discharged up to 1 year
Other outcomes:
measure: Activation reason
timeFrame: Through intervention completion, an average of 45 minutes
measure: Interventions done by the RRT
timeFrame: Through intervention completion, an average of 45 minutes
measure: Outcomes from the RRT -event
timeFrame: Through intervention completion, an average of 45 minutes
measure: Evaluations by the RRT
timeFrame: Through intervention completion, an average of 45 minutes
Locations:
Study officials:
References: