Back to resultsChecklists Resuscitation Emergency Department
Primary Purpose
Shortness of Breath, Chest Pain, Abdominal Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Emergency Manual
Sponsored by
About this trial
This is an interventional treatment trial for Shortness of Breath
Eligibility Criteria
Inclusion Criteria: Consecutive priority 1 patients managed in the resuscitation room of Skåne University Hospital at Lund's Emergency Department Exclusion Criteria: None
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients managed with Emergency Manual access
Arm Description
Consecutive priority 1 patients managed by resuscitation teams with access to an Emergency Manual
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05649891
Brief Title
Checklists Resuscitation Emergency Department
Official Title
Clinical Use of an Emergency Manual by Resuscitation Teams and Impact on Performance in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shortness of Breath, Chest Pain, Abdominal Pain, Altered Mental Status, Syncope, Seizures, Vertigo, Trauma, Allergic Reaction, Fever, Cardiac Arrest, Asthma Acute, COPD Exacerbation Acute, Pneumonia, Pulmonary Edema - Acute, Bradycardia, Tachycardia, Shock, Burns, Poisoning, Diabetic Ketoacidosis, Hyperglycemic Hyperosmolar Nonketotic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients managed with Emergency Manual access
Arm Type
Experimental
Arm Description
Consecutive priority 1 patients managed by resuscitation teams with access to an Emergency Manual
Intervention Type
Other
Intervention Name(s)
Emergency Manual
Intervention Description
Collection of crisis checklists and fact sheets
Primary Outcome Measure Information:
Title
Degree of indication of interventions performed thanks to Do-Confirm Emergency Manual use
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Team's subjective evaluation of Emergency Manual value
Description
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.
Time Frame
1 hour
Title
Degree of indication of interventions that might have been performed had the Emergency Manual been used
Description
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.
Time Frame
1 hour
Title
Structured interviews
Description
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
Time Frame
Up to 8 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consecutive priority 1 patients managed in the resuscitation room of Skåne University Hospital at Lund's Emergency Department
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Dryver, MD
Phone
+46-738-198261
Email
eric.dryver@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Ulf Ekelund, MD PhD
Phone
+46-702-049480
Email
ulf.ekelund@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Dryver, MD
Organizational Affiliation
Skane's University Hospital in Lund, Emergency Department
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Checklists Resuscitation Emergency Department
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