Rapid Response Teams - How and Who?

ConditionsHospital Rapid Response Team Early Warning Score Intensive Care Units

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNordsjaellands Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admitted to any general ward of the hospital AND

Aged ≥ 18 years AND

In need of RRT attention

Disqualifiers

Age < 18

Admitted to the delivery ward

Admitted to any ward in the anesthetic department

ICU

Trial design

Design model

Parallel

Treatments tested in this trial

Rapid Response Team Composition_ ICU Nurse
Other intervention
In case of deterioration a Rapid Response Team may be activated. We will be examining the composition of the teams alternating between a MET or a CCOT.

Treatment groups

1,500 Participants

are divided into 2 treatment groups

Group A: Critical Care Outreach Team ModelExperimental treatment 1 intervention

Group B: Medical Emergency team ModelNo intervention 0 interventions

Trial outcomes

Primary outcomes

30-Day Mortality

Binary outcome measured via the patient Electronic Medical Records

Time frame

up to 30 days

In-Hospital Cardiac Arrest (IHCA)

Binary outcome measured via the patient Electronic Medical Records: defined as any IHCA post randomization and until discharge or 30 days post randomization

Time frame

up to 30 days

Unplanned Admission to the Intensive Care Unit

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

Time frame

up to 30 days

Unexpected Death

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

Time frame

up to 30 days

Secondary outcomes

Activation of escape protocol

Besides a few defined criteria the nurse may at any time activate the escape protocol and summon the ICU doctor to the patient immediately. If this is done at any time, it will be logged in the Electronic Medical Records and subsequently registered in the eCRF

Time frame

Through intervention completion, an average of 45 minutes

90-day mortality

Binary outcome measured via the Patient electronic medical records.

Time frame

90 days

Time Spent Bedside

Continuous outcome measured via the Patient Electronic medical records - the MET-note. Defined in Minutes

Time frame

Through intervention completion, an average of 45 minutes

Initiation of End of Life Care (EOL)

Binary outcome measured via the Patient Electronic Medical Records, defined as any treatment limitations involving cessation of all treatment, prescription of a safety/comfort package, No increase in treatment level - no ICU involvement and no MET involvement.

Time frame

Maximum 30 days post randomization

Other outcomes

Activation reason

Exploratory outcome regarding the reason for activating the MET

Time frame

Through intervention completion, an average of 45 minutes

Interventions done by the RRT

Exploratory outcome regarding the interventions done by the RRT

Time frame

Through intervention completion, an average of 45 minutes

Outcomes from the RRT -event

Exploratory outcome regarding the outcomes when the RRT-event is ending.

Time frame

Through intervention completion, an average of 45 minutes

Evaluations by the RRT

Exploratory outcome regarding the evaluations done by the RRT

Time frame

Through intervention completion, an average of 45 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nordsjaellands Hospital

Lead sponsor

Source ClinicalTrials.gov

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