Hospital Rapid Response TeamRRT-CompNCT04507737
Rapid Response Teams - How and Who?
A study testing Rapid Response Team Composition_ ICU Nurse in people with Hospital Rapid Response Team and Early Warning Score, run by Nordsjaellands Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Rapid Response Team, Early Warning Score, Intensive Care Units
- What is being tested?
- Rapid Response Team Composition_ ICU Nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to any general ward of the hospital AND
- Aged ≥ 18 years AND
- In need of RRT attention
Who cannot join
- Age < 18
- Admitted to the delivery ward
- Admitted to any ward in the anesthetic department
- ICU
- High Dependency Unit
- Post Operation Department
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Nordsjællands Hospital
Hillerød, Danmark, 3400
Morten B Føns-Sønderskov, MD, 51896094, morten.bo.foens-soenderskov@regionh.dk
Anne Marie Kodal, Master of nursing, 48297511, anne.marie.kodal@regionh.dk
About this study
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.
Read the 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
- Being tested
- Rapid Response Team Composition_ ICU Nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Response Team Composition_ ICU NurseOther
Also called Rapid Response Team Composition - ICU Doctor + Nurse
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Mortality
Binary outcome measured via the patient Electronic Medical Records
Measured: 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
Measured: 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
Measured: 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
Measured: up to 30 days
Secondary outcomes (7)
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
Measured: Through intervention completion, an average of 45 minutes
90-day mortality
Binary outcome measured via the Patient electronic medical records.
Measured: 90 days
Time Spent Bedside
Continuous outcome measured via the Patient Electronic medical records - the MET-note. Defined in Minutes
Measured: 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.
Measured: Maximum 30 days post randomization
Score To Door Time
Continuous outcome calculated via the Patient Electronic medical records the MET-note, defined as the time from activation of the RRT until arrival at the ICU.
Measured: Through intervention completion, an average of 4 hours
Survival until discharge
Binary outcome measured via the patient Electronic Medical Records
Measured: From date of admission until the date discharged up to 1 year.
Length of Stay
Continuous outcome measured via the Patient Electronic Medical records defined in Days, measured from admission date till discharge or death date.
Measured: From date of admission until discharged up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Sep 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital Rapid Response TeamStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507737
- Sponsor's protocol ID
- pending
- Acronym
- RRT-Comp
- Status last verified
- Sep 2025
- First submitted
- 11 May 2020
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pending
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Response Teams - How and Who? A Randomized Controlled Trial Examining the Composition of the RRT in a General Hospital
- ClinicalTrials.gov ID
- NCT04507737
- Acronym / sponsor ID
- RRT-Comp / pending
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critical Care Outreach Team Model | Experimental | Other: Rapid Response Team Composition_ ICU NurseWhen 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to any general ward of the hospital AND
- Aged ≥ 18 years AND
- In need of RRT attention
Key exclusion criteria (13 listed)
- Age < 18
- Admitted to the delivery ward
- Admitted to any ward in the anesthetic department
- Not admitted at the time of call
- Any patient who cannot be randomized at the time of call
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Response Team Composition_ ICU NurseAlso: Rapid Response Team Composition - ICU Doctor + NurseIn 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. | Other | Critical Care Outreach Team Model |
Primary outcome
30-Day Mortality
Time frame: up to 30 days
Binary outcome measured via the patient Electronic Medical Records
In-Hospital Cardiac Arrest (IHCA)
Time frame: up to 30 days
Binary outcome measured via the patient Electronic Medical Records: defined as any IHCA post randomization and until discharge or 30 days post randomization
Unplanned Admission to the Intensive Care Unit
Time frame: up to 30 days
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
Unexpected Death
Time frame: up to 30 days
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
7 secondary outcomes
Activation of escape protocol
Time frame: Through intervention completion, an average of 45 minutes
90-day mortality
Time frame: 90 days
Time Spent Bedside
Time frame: Through intervention completion, an average of 45 minutes
Initiation of End of Life Care (EOL)
Time frame: Maximum 30 days post randomization
Score To Door Time
Time frame: Through intervention completion, an average of 4 hours
Survival until discharge
Time frame: From date of admission until the date discharged up to 1 year.
Length of Stay
Time frame: From date of admission until discharged up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: Yes. Pending
Related trials for Hospital Rapid Response Team
Active, not recruiting
Rapid Response Home Care as an Alternative to Acute Admission
Infection
RecruitingObservational study
Prospective Cohort Study of Rapid Response Team
Hospital Medical Emergency Team, Medicine, Emergency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Response Team Composition_ ICU Nurse in people with Hospital Rapid Response Team and Early Warning Score, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Mortality (time frame: up to 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.