Development and Evaluation of a Patient Safety Model

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.

Study Overview

• Status: Completed
• Conditions: Emergency Medicine
• Intervention / Treatment: Other: New risk assessment

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 Type: Interventional
• Enrollment (Actual): 34556
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herning, Denmark, 7400
    • Herning Regional Hospital
  • Horsens, Denmark, 8700
    • Horsens Regional Hospital
  • Randers, Denmark, 8930
    • Randers Regional Hospital
  • Viborg, Denmark, 8800
    • Viborg Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: New risk assessment; New risk assesment	Other: New risk assessment; 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.
NO_INTERVENTION: Standard; Standard risk assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Participants will be followed for the length of stay in the Emergency Department, an expected period of 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	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)	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	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	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	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	Participants will be followed for the duration of hospital stay, an expected average of 1 week

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Herning Hospital; Horsens Hospital; Randers Regional Hospital; Central Jutland Regional Hospital
• Investigators: Principal Investigator: Gitte B Tygesen, PhD student, Horsens Regional Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2017
• Primary Completion (ACTUAL): May 31, 2018
• Study Completion (ACTUAL): May 31, 2018

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (ACTUAL): March 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Patient Safety; Risk Factors; Risk Assessment; Quality Indicators, Health Care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 18296453

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No