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
NCT number | NCT03457272 |
Other study ID # | 18296453 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 30, 2017 |
Est. completion date | May 31, 2018 |
Verified date | October 2019 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34556 |
Est. completion date | May 31, 2018 |
Est. primary completion date | May 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Herning Regional Hospital | Herning | |
Denmark | Horsens Regional Hospital | Horsens | |
Denmark | Randers Regional Hospital | Randers | |
Denmark | Viborg Regional Hospital | Viborg |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, Central Jutland Regional Hospital, Herning Hospital, Horsens Hospital, Randers Regional Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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