Clinical trial NCT03457272: Development and Evaluation of a Patient Safety Model
Official title: Development and Evaluation of a Patient Safety Model Targeting Severe Clinical Deterioration and Safety Awareness in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency Medicine
Keywords: Patient Safety
Risk Factors
Quality Indicators, Health Care
Risk Assessment
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Horsens Hospital
name: Central Jutland Regional Hospital
name: Randers Regional Hospital
name: Herning Hospital
name: Aarhus University Hospital
First posted: 2018-03-07
Enrollment: 34556
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Adult somatic patients (≥18 years) admitted to the participating Emergency Departments

Exclusion Criteria:

* 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

Primary outcomes:
measure: The proportion of patients with severe clinical deterioration in the ED
timeFrame: Participants will be followed for the length of stay in the Emergency Department, an expected period of 48 hours
Secondary outcomes:
measure: Safety awareness
timeFrame: up to 4 weeks (in baseline and in intervention)
measure: Proportion of participants with severe safety events
timeFrame: Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours
measure: Proportion of participants admitted to the Intensive Care Units from the Emergency Departments
timeFrame: Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours
measure: Proportion of participants admitted to the Intensive Care Units from the wards
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Length of stay at the Intensive Care Unit
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Proportion of 30 day - readmission
timeFrame: Participants will be followed for the duration of 30 days after the hospital stay
measure: Length of stay in the Emergency Departments
timeFrame: Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours
measure: Length of stay in the Hospital
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Proportion of in-hospital death
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Proportion of in-hospital cardiac/respiratory arrest
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Herning Regional Hospital
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
city: Randers
country: Denmark
facility: Randers Regional Hospital
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
Study officials:
affiliation: Regionshospitalet Horsens
name: Gitte B Tygesen, PhD student
role: PRINCIPAL_INVESTIGATOR
References: