Rapid Response Teams - How and Who?

NCT04507737 | Recruiting DMC

• 1 other identifier: pending
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 30-Day Mortality

  Binary outcome measured via the patient Electronic Medical Records

  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

  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

  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

  up to 30 days

Secondary Outcomes (7)

• Activation of escape protocol

  Through intervention completion, an average of 45 minutes

• 90-day mortality

  90 days

• Time Spent Bedside

  Through intervention completion, an average of 45 minutes

• Initiation of End of Life Care (EOL)

  Maximum 30 days post randomization

• Score To Door Time

  Through intervention completion, an average of 4 hours

Other Outcomes (4)

• Activation reason

  Through intervention completion, an average of 45 minutes

• Interventions done by the RRT

  Through intervention completion, an average of 45 minutes

• Outcomes from the RRT -event

  Through intervention completion, an average of 45 minutes

Study Arms (2)

Critical Care Outreach Team Model

EXPERIMENTAL

When a patient deteriorates and is in need of a Rapid Response Team, this arm will deploy a Critical Care Outreach Team Model consisting of an ICU-trained Nurse with the on-duty physician of the general ward and a nurse from the general ward.

Other: Rapid Response Team Composition_ ICU Nurse

Medical Emergency team Model

NO INTERVENTION

When a patient deteriorates and is in need of a Rapid Response Team, this arm will deploy a Medical Emergency Team Model, consisting of an ICU-trained Doctor as well as an ICU-trained Nurse with the on-duty physician of the general ward and a nurse from the general ward.

Interventions

Rapid Response Team Composition_ ICU Nurse OTHER

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.

Also known as: Rapid Response Team Composition - ICU Doctor + Nurse

Critical Care Outreach Team Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Nordsjællands Hospital

Hillerød, Danmark, 3400, Denmark

RECRUITING

MeSH Terms

Interventions

Nurses

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: August 11, 2020
• Study Start: September 1, 2021
• Primary Completion: December 30, 2025
• Study Completion: January 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 9 months after finalized randomisation for 5 years

Locations

DK (1)