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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05649891
Other study ID # 2022-01896-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date March 2024

Study information

Verified date December 2022
Source Region Skane
Contact Eric Dryver, MD
Phone +46-738-198261
Email eric.dryver@med.lu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will systematically evaluate how an emergency manual-a collection of checklists and fact sheets-affects the performance of resuscitation teams during the management of priority one patients in an emergency department.


Description:

Simulation-based studies indicate that crisis checklist use improves management of patients with critical conditions in the emergency department (ED). This six-month-long study prospectively evaluates a digital emergency manual-a collection of crisis checklists and fact sheets-during the management of priority 1 patients in the Skåne University Hospital at Lund's ED.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2000
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Consecutive priority 1 patients managed in the resuscitation room of Skåne University Hospital at Lund's Emergency Department Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms

  • Abdominal Pain
  • Allergic Reaction
  • Altered Mental Status
  • Asthma Acute
  • Bradycardia
  • Burns
  • Cardiac Arrest
  • Chest Pain
  • COPD Exacerbation Acute
  • Diabetic Ketoacidosis
  • Dyspnea
  • Emergencies
  • Fever
  • Hypersensitivity
  • Ketosis
  • Pneumonia
  • Poisoning
  • Pulmonary Edema
  • Seizures
  • Shock
  • Shortness of Breath
  • Syncope
  • Tachycardia
  • Trauma
  • Vertigo

Intervention

Other:
Emergency Manual
Collection of crisis checklists and fact sheets

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Region Skane

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of indication of interventions performed thanks to Do-Confirm Emergency Manual use The primary outcome measures are the proportions of interventions performed thanks to Do-Confirm EM use graded as indicated, of neutral relevance, and not indicated. 1 hour
Secondary Team's subjective evaluation of Emergency Manual value The team's subjective evaluation of the EM's value is recorded prior to the logging out from the EM using a Likert scale of 1 to 6. 1 hour
Secondary Degree of indication of interventions that might have been performed had the Emergency Manual been used Fifty patients that presented during the six-month period preceding EM implementation, are identified. These 50 patients are selected based on matching to the 50 patients where the EM was used, using age, presenting complaint and relevant co-morbidities. In addition, fifty patients where the EM was not used during the pilot study period are also identified based on the same matching process. The EM is accessed to determine whether additional interventions would have been performed, had the EM been used. All interventions-those actually performed as well as those that might have been performed had the EM been used-are then assessed for degree of indication by three external reviewers. 1 hour
Secondary Structured interviews Teams can electronically request contact with the investigators to report specific events related to EM use. If so, the following data is extracted during a structured interview:
patient age, sex, presenting complaint and suspected diagnosis
seniority of the physician initially in charge of the case
events or concerns relating to EM use
mode of EM use (Do-Confirm, Read-Do, Sampling) and sections relevant to the case
personnel's assessment of the impact of the EM on patient care
personnel's assessment of impact of the EM on team members and teamwork
personnel's suggestions for EM improvement
Up to 8 weeks
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