Development and Evaluation of a Patient Safety Model

NCT03457272 | Completed DMC

• 1 other identifier: 18296453
• Study Type: interventional
• Target: 34,556
• Locations: 1 country
• Sites: 4

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.

Conditions

Emergency Medicine

Keywords

Patient Safety; Risk Factors; Quality Indicators, Health Care; Risk Assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Safety awareness

  up to 4 weeks (in baseline and in intervention)

• Proportion of participants with severe safety events

  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

  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

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

• Length of stay at the Intensive Care Unit

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

Study Arms (2)

New risk assessment

EXPERIMENTAL

New risk assesment

Other: New risk assessment

Standard

NO INTERVENTION

Standard risk assessment

Interventions

New risk assessment OTHER

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.

New risk assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Horsens Hospital: collaborator
• Central Jutland Regional Hospital: collaborator
• Randers Regional Hospital: collaborator
• Herning Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (4)

Herning Regional Hospital

Herning, 7400, Denmark

Location

Horsens Regional Hospital

Horsens, 8700, Denmark

Location

Randers Regional Hospital

Randers, 8930, Denmark

Location

Viborg Regional Hospital

Viborg, 8800, Denmark

Location

Study Officials

• Gitte B Tygesen, PhD student

  Regionshospitalet Horsens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: March 7, 2018
• Study Start: October 30, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: October 14, 2019

Record last verified: 2019-10

Locations

DK (4)