Emergency Medicine Clinical Trial
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.
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.
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