Emergency MedicineNCT03457272
Development and Evaluation of a Patient Safety Model
A study testing New risk assessment in people with Emergency Medicine, run by University of Aarhus at 4 sites in Denmark.
Trial summary
Despite systems for early detection of critical illness, 12% of patients in the emergency department develop clinical deterioration with an increased risk of death as a result. There is a need for a intervention to support the identification and clinical management of patients at risk of clinical deterioration earlier… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Medicine
- What is being tested?
- New risk assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34,556 participants
- Where
- 4 sitesDenmark
- Study dates
- 30 Oct 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult somatic patients (≥18 years) admitted to the participating Emergency Departments
Who cannot join
- Patients with injuries caused by trauma
- Patients received with cardiac arrest, as a surgical or medical call (can participate if admitted to the Emergency Department and not directly transferred to the Intensive Care Unit)
- Patients hospitalized with a psychiatric diagnosis as the primary cause of admission
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Herning Regional Hospital
Herning, 7400
Horsens Regional Hospital
Horsens, 8700
Randers Regional Hospital
Randers, 8930
Viborg Regional Hospital
Viborg, 8800
About this study
Official title: Development and Evaluation of a Patient Safety Model Targeting Severe Clinical Deterioration and Safety Awareness in the Emergency Department
Despite systems for early detection of critical illness, 12% of patients in the emergency department develop clinical deterioration with an increased risk of death as a result.
There is a need for a intervention to support the identification and clinical management of patients at risk of clinical deterioration earlier hospitalization. The Cincinnati Children's Hospital has introduced a model that systematically complements systems for early detection of critical illness with the assessment of patient and relatives concern, clinical intuition and concern of the staff. In addition, the model includes formalized organizational processes aimed at systematic review of risk patients and early treatment efforts. Studies from United States indicate that the model can lead to reduction of serious incidental events and increase the staff awareness of the situation. The Cincinnati model is designed for children and has not yet been studied in a controlled study.
Purpose To develop and investigate the impact of a Danish patient safety model. Method A literature review is conducted to identify risk factors that should be included in a model aimed at detecting and managing clinical deterioration. A patient safety model is developed on the basis of the literature review and the Cincinnati model and is tested in a pilot study. In a controlled intervention study, the effect is investigated against severe clinical deterioration. The intervention is carried out at the emergency departments at Horsens Regional Hospital and Viborg Regional Hospital with the regional hospitals in Randers and Herning as control departments.
Read the detailed description
Preventing deterioration in acute patients is of great interest internationally. Studies demonstrate that clinical deterioration can be measured up to 24 hours before a heart arrest or intensive care admission in the vital signs. Therefore, the health services have implemented early warning systems to detect deterioration and critical illness.
Despite the systems, 12% of patients in an emergency department still develop severe clinical deterioration with increased risk of death as a result. Research indicates that the reasons for this may be diverse and further action to support the early identification and treatment of patients at risk of deterioration is needed.
Cincinnati Children's Hospital has introduced a patient safety model to ensure identification and mitigation of patient risk through escalated observation, care and treatment depending on the individual's risk for clinical deterioration. The model includes early warning systems, but as something new, it is supplemented with systematic evaluation of more subjective factors such as staff's clinical gaze and concerns, patient/relatives' concerns, communication problems and high risk therapy.
In an observational study, the Cincinnati Situation Awareness model was found to be associated with a near 50% reduction in unsafe intensive care unit transfers and decrease in severe safety events. However, the model has so far not been evaluated in a controlled study or an adult population.
The study will consist of three substudies; the overall study design is based on a framework for implementation of complex interventions following a four-step-process entailing development, pilot test, evaluation and reporting.
Study I. The study will consist of a systematic review and aims to identify risk factors associated with severe clinical deterioration and severe safety events that should ultimately be considered for inclusion in the patient safety model.
The aim of study II is to develop a patient safety model based on the components in the Cincinnati Situation Awareness model and explore its feasibility. The Danish patient safety model is expected to consist of systematic patient risk screening, bed huddles and audits of intensive care unit transfers.
Relevant aspects that should be included in the systematic patient risk screening are identified based on the literature study. A multidisciplinary panel is established to ensure that the choice of risk parameters is made on the basis of risk factors with the highest impact and the applicability to standard care.
A pilot test of the model will be conducted to evaluate the feasibility of methods and procedures based on the principles of the Medical Research Council guidance.
The final model will be investigated in a prospective controlled intervention study design to examine the effect in relation to severe clinical deterioration, safety awareness and serious adverse events (Study III).
The study will follow a Quasi-experimental design. The intervention will be implemented at the Emergency Departments and Intensive Care Units at Horsens and Viborg Regional Hospitals with the Emergency Departments at Herning and Randers Regional Hospitals as controls.
A positive outcome is expected to increase patient safety by reducing patients with severe deterioration, serious adverse events and increase staff safety awareness.
- Conditions
- Emergency Medicine
- Being tested
- New risk assessment
- Keywords
- Patient Safety, Risk Factors, Quality Indicators, Health Care, Risk Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New risk assessmentOther
Consists of a simple physiological scoring system and an assessment of patients who should assist healthcare professionals in identifying patients at risk of clinical deterioration earlier and support timely response and escalation of observation, care and treatment and thereby prevent the development of severe clinical deterioration.
The patients included in the study will be monitored using the new risk assessment tool with different intervals according to the patients' conditions. Underlying the tool are algorithms of action for intervention in the critically ill patient, inter professional guidelines and guidance for standardized monitoring, escalation plans and huddles.
| Study group | Role | What they receive |
|---|---|---|
| New risk assessment | Experimental | New risk assesment Receives: Other: New risk assessment |
| Standard | No intervention | Standard risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with severe clinical deterioration in the ED
Severe clinical deterioration will be measured by the early warning system used in Central Denmark Region based on vital signs collected from medical records. The score is aggregated and the vital signs include respiratory rate, SatO2, systolic blood pressure, pulse, temperature and level of consciousness measured by APVU.
The initial deterioration process from score 0-1 will be considered as "no deterioration". Deterioration directly to score 2 and above, or deterioration from score ≥2 and further will be considered severe.
Measured: Participants will be followed for the length of stay in the Emergency Department, an expected period of 48 hours
Secondary outcomes (10)
Safety awareness
Staff safety awareness will be measured in the last months of the baseline period and in the last months of the intervention period by the Safety Attitudes Questionnaire adapted and validated for Danish hospital settings. The questionnaire consists of 31 items rated on a 5-point Likert type scale. The questionnaire comprises six subscales: teamwork climate, safety climate, stress recognition, job satisfaction, working conditions, and perceptions of unit management.
Measured: up to 4 weeks (in baseline and in intervention)
Proportion of participants with severe safety events
Severe safety events is a composite outcome consisting of either unexpected in-hospital cardiac/respiratory arrest, unexpected in-hospital death (when no Do-Not-Resuscitate order has been prescribed) and unanticipated intensive care unit transfer from the Emergency Department
Measured: Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours
Proportion of participants admitted to the Intensive Care Units from the Emergency Departments
Proportion of participants referred to the Intensive Care Units from the Emergency Departments
Measured: Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours
Proportion of participants admitted to the Intensive Care Units from the wards
Proportion of participants admitted to the Intensive Care Units from the wards
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Length of stay at the Intensive Care Unit
The length of time patients spend in the Intensive Care Units
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Proportion of 30 day - readmission
Readmission until 30 days after the Emergency Department admission (Central Denmark Region)
Measured: Participants will be followed for the duration of 30 days after the hospital stay
Length of stay in the Emergency Departments
The length of time patients spend in the Emergency Department
Measured: Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours
Length of stay in the Hospital
The length of time patients spend in the hospital
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Proportion of in-hospital death
The proportion of participants who die in the hospital
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Proportion of in-hospital cardiac/respiratory arrest
The proportion of participants who have a cardiac or respiratory arrest in the hospital
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start30 Oct 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency MedicineStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two intervention and two control departments. The intervention consists of a risk assesment to ensure systematic and standardized identification of patients in risk of clinical deterioration and a decision support algorithm. Actions are undertaken on the basis of the standardized decision support and when a patient is determined to be at risk escalation plans are activated. As part of the intervention, huddles are conducted and patients at risk are interdisciplinarily discussed.
- Masking
- None (open label)
- Enrolment
- 34,556 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Horsens Hospital, Central Jutland Regional Hospital, Randers Regional Hospital, Herning Hospital, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Gitte B Tygesen, PhD student, Principal investigator, Regionshospitalet Horsens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457272
- Sponsor's protocol ID
- 18296453
- Status last verified
- Oct 2019
- First submitted
- 4 Dec 2017
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Patient Safety Model Targeting Severe Clinical Deterioration and Safety Awareness in the Emergency Department
- ClinicalTrials.gov ID
- NCT03457272
- Acronym / sponsor ID
- 18296453
- Conditions
- Emergency Medicine
- Keywords
- Patient Safety, Risk Factors, Quality Indicators, Health Care, Risk Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34,556 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Horsens Hospital, Central Jutland Regional Hospital, Randers Regional Hospital, Herning Hospital, Aarhus University Hospital
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 7 Mar 2018 (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.
Despite systems for early detection of critical illness, 12% of patients in the emergency department develop clinical deterioration with an increased risk of death as a result.
There is a need for a intervention to support the identification and clinical management of patients at risk of clinical deterioration earlier hospitalization. The Cincinnati Children's Hospital has introduced a model that systematically complements systems for early detection of critical illness with the assessment of patient and relatives concern, clinical intuition and concern of the staff. In addition, the model includes formalized organizational processes aimed at systematic review of risk patients and early treatment efforts. Studies from United States indicate that the model can lead to reduction of serious incidental events and increase the staff awareness of the situation. The Cincinnati model is designed for children and has not yet been studied in a controlled study.
Purpose To develop and investigate the impact of a Danish patient safety model. Method A literature review is conducted to identify risk factors that should be included in a model aimed at detecting and managing clinical deterioration. A patient safety model is developed on the basis of the literature review and the Cincinnati model and is tested in a pilot study. In a controlled intervention study, the effect is investigated against severe clinical deterioration. The intervention is carried out at the emergency departments at Horsens Regional Hospital and Viborg Regional Hospital with the regional hospitals in Randers and Herning as control departments.
Detailed description
Preventing deterioration in acute patients is of great interest internationally. Studies demonstrate that clinical deterioration can be measured up to 24 hours before a heart arrest or intensive care admission in the vital signs. Therefore, the health services have implemented early warning systems to detect deterioration and critical illness.
Despite the systems, 12% of patients in an emergency department still develop severe clinical deterioration with increased risk of death as a result. Research indicates that the reasons for this may be diverse and further action to support the early identification and treatment of patients at risk of deterioration is needed.
Cincinnati Children's Hospital has introduced a patient safety model to ensure identification and mitigation of patient risk through escalated observation, care and treatment depending on the individual's risk for clinical deterioration. The model includes early warning systems, but as something new, it is supplemented with systematic evaluation of more subjective factors such as staff's clinical gaze and concerns, patient/relatives' concerns, communication problems and high risk therapy.
In an observational study, the Cincinnati Situation Awareness model was found to be associated with a near 50% reduction in unsafe intensive care unit transfers and decrease in severe safety events. However, the model has so far not been evaluated in a controlled study or an adult population.
The study will consist of three substudies; the overall study design is based on a framework for implementation of complex interventions following a four-step-process entailing development, pilot test, evaluation and reporting.
Study I. The study will consist of a systematic review and aims to identify risk factors associated with severe clinical deterioration and severe safety events that should ultimately be considered for inclusion in the patient safety model.
The aim of study II is to develop a patient safety model based on the components in the Cincinnati Situation Awareness model and explore its feasibility. The Danish patient safety model is expected to consist of systematic patient risk screening, bed huddles and audits of intensive care unit transfers.
Relevant aspects that should be included in the systematic patient risk screening are identified based on the literature study. A multidisciplinary panel is established to ensure that the choice of risk parameters is made on the basis of risk factors with the highest impact and the applicability to standard care.
A pilot test of the model will be conducted to evaluate the feasibility of methods and procedures based on the principles of the Medical Research Council guidance.
The final model will be investigated in a prospective controlled intervention study design to examine the effect in relation to severe clinical deterioration, safety awareness and serious adverse events (Study III).
The study will follow a Quasi-experimental design. The intervention will be implemented at the Emergency Departments and Intensive Care Units at Horsens and Viborg Regional Hospitals with the Emergency Departments at Herning and Randers Regional Hospitals as controls.
A positive outcome is expected to increase patient safety by reducing patients with severe deterioration, serious adverse events and increase staff safety awareness.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consists of two intervention and two control departments. The intervention consists of a risk assesment to ensure systematic and standardized identification of patients in risk of clinical deterioration and a decision support algorithm. Actions are undertaken on the basis of the standardized decision support and when a patient is determined to be at risk escalation plans are activated. As part of the intervention, huddles are conducted and patients at risk are interdisciplinarily discussed.
| Arm | Type | Receives |
|---|---|---|
| New risk assessment | Experimental | Other: New risk assessmentNew risk assesment |
| Standard | No intervention | –Standard risk assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult somatic patients (≥18 years) admitted to the participating Emergency Departments
Key exclusion criteria (3 listed)
- Patients with injuries caused by trauma
- Patients received with cardiac arrest, as a surgical or medical call (can participate if admitted to the Emergency Department and not directly transferred to the Intensive Care Unit)
- Patients hospitalized with a psychiatric diagnosis as the primary cause of admission
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 |
|---|---|---|
| New risk assessmentConsists of a simple physiological scoring system and an assessment of patients who should assist healthcare professionals in identifying patients at risk of clinical deterioration earlier and support timely response and escalation of observation, care and treatment and thereby prevent the development of severe clinical deterioration. The patients included in the study will be monitored using the new risk assessment tool with different intervals according to the patients' conditions. Underlying the tool are algorithms of action for intervention in the critically ill patient, inter professional guidelines and guidance for standardized monitoring, escalation plans and huddles. | Other | New risk assessment |
Primary outcome
The proportion of patients with severe clinical deterioration in the ED
Time frame: Participants will be followed for the length of stay in the Emergency Department, an expected period of 48 hours
Severe clinical deterioration will be measured by the early warning system used in Central Denmark Region based on vital signs collected from medical records. The score is aggregated and the vital signs include respiratory rate, SatO2, systolic blood pressure, pulse, temperature and level of consciousness measured by APVU. The initial deterioration process from score 0-1 will be considered as "no deterioration". Deterioration directly to score 2 and above, or deterioration from score ≥2 and further will be considered severe.
10 secondary outcomes
Safety awareness
Time frame: up to 4 weeks (in baseline and in intervention)
Proportion of participants with severe safety events
Time frame: Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours
Proportion of participants admitted to the Intensive Care Units from the Emergency Departments
Time frame: Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours
Proportion of participants admitted to the Intensive Care Units from the wards
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Length of stay at the Intensive Care Unit
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Proportion of 30 day - readmission
Time frame: Participants will be followed for the duration of 30 days after the hospital stay
Length of stay in the Emergency Departments
Time frame: Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours
Length of stay in the Hospital
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Proportion of in-hospital death
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Proportion of in-hospital cardiac/respiratory arrest
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
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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. This study is not recruiting at the moment.
Gitte B Tygesen, PhD student principal investigator
Regionshospitalet Horsens
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New risk assessment in people with Emergency Medicine, run by University of Aarhus at 4 sites 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with severe clinical deterioration in the ED (time frame: Participants will be followed for the length of stay in the Emergency Department, an expected period of 48 hours). 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 14 Oct 2019; AzTrials last refreshed its copy on 31 Oct 2026.