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Digitalized Differential Diagnosis Broadening in Emergency Rooms (DDX-BRO)

Primary Purpose

Emergencies, Diagnoses Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Isabel Pro - The DDx generator (CDDS)
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Emergencies focused on measuring Emergency, Diagnostic Error, Diagnostic Safety, Misdiagnosis, CDDS, Computerized Decision Support System, Diagnostic Quality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed Consent signed by the subject
  • Presentation to the ER with fever, abdominal pain, syncope or Non-specific complaint (NSC) as chief complaint
  • Triaged as "not vitally threatened"
  • The study subject is 18 years old or older.

Exclusion Criteria:

  • Trauma as chief complaint
  • Pregnancy
  • Worsening of a known pre-existing condition or medical referral with a definite diagnosis
  • Inability to follow the informed consent and investigation procedures
  • Previous enrolment into the current investigation

Sites / Locations

  • Dept. of internal and emergency medicine, Spital Münsigen
  • Dept. of Internal and Emergency Medicine, Spital Tiefenau
  • Dept. of Emergency Medicine, Inselspital, University Hospital Bern
  • Dept. of Internal and Emergency Medicine, Buergerspital Solothurn

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Usual Care + CDDS usage

Usual Care

Arm Description

Patients presenting to the ER and included in the study during the ER's intervention period will be treated and diagnosed by the ER physicians as usual but with support of the CDDS.

Patients presenting to the ER and included in the study during the ER's intervention period will be treated and diagnosed by the ER physicians as usual without support of the CDDS.

Outcomes

Primary Outcome Measures

Diagnostic quality risk score
Primary endpoint is a binary score indicating a diagnostic quality risk, composed of: Death within 14 days after emergency room discharge (yes/no) Unscheduled medical care (emergency room revisits, General Practitioner visits or hospitalization) within 14 days after emergency room discharge (yes/no) Unexpected intensive care unit admission from ward within 24 hours when hospitalized (yes/no) Diagnostic discrepancy between the emergency room discharge diagnosis and the current diagnosis 14 days after emergency room discharge (yes/no)

Secondary Outcome Measures

Death within 14 days after Emergency Room discharge (yes/no)
Patient died within the timeframe of emergency discharge
Unexpected intensive care unit admission
Number of patients with unexpected intensive care unit admission from ward within 24 hours when hospitalized (yes/no)
Diagnostic discrepancy
Number of patients with diagnostic discrepancy between the Emergency Room discharge diagnosis and the current diagnosis 14 days after ER discharge (yes/no)
Unscheduled medical care 72 hours, 7 days and 14 days
Number of patients with unscheduled medical care 72 hours, 7 days and 14 days after emergency room discharge
Length of emergency room stay
Number of hours the patient spent in emergency room routine care
Length of hospital stay
Number of days the patient was hospitalized (if hospitalized)
Diagnostic tests
Number of diagnostic tests performed during emergency room routine care
Resource consumption in the Emergency Department
Resource consumption (total costs for personnel and diagnostics) during emergency room
Resource consumption
Resource consumption (total costs for personnel and diagnostics) during hospitalization
Discharge destination
Home / Hospital (intern) / Hospital (extern) / Nursing home / Rehabilitation / Other
Number of differential diagnoses
Number of differential diagnoses provided by the physicians at emergency room discharge
CDDS potential
Number of cases where the generated differential diagnosis list entails the diagnoses after 14 days
Diagnostic error
Diagnostic error based on full chart review for a random subset
CDDS usage
Number of CDDS queries
Physician confidence calibration, advice seeking and collaboration
Assessed by qualitative methods such as observations of physicians or interviews and focus groups with physicians (no patients directly involved).

Full Information

First Posted
March 21, 2022
Last Updated
July 20, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05346523
Brief Title
Digitalized Differential Diagnosis Broadening in Emergency Rooms
Acronym
DDX-BRO
Official Title
Effects of Digitalized Differential Diagnosis Broadening Using a Computerized Diagnostic Decision Support Tool on Diagnostic Quality in Emergency Room Patients - a Multi-centre Cluster Randomized Cross-over Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
July 13, 2023 (Actual)
Study Completion Date
July 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation

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
10 to 35% of patients admitted to an emergency department receive an incorrect diagnosis. Not surprisingly, given the wide variety of health conditions encountered in emergency medicine, physicians often do not consider, remember, or know all possible diagnoses that fit the patient's symptoms. Nowadays, computer software (CDDS) is able to support physicians with a list of possible diagnoses by matching entered patient data to a large database with diagnoses. However, it is still unclear how the use of such a CDDS actually affects the diagnostic quality and workflow in 'real world' ER routine care. Therefore, the aim of this cluster-randomized cross-over trial is to evaluate the consequences of CDDS usage on diagnostic quality, patient outcomes and diagnostic workflow within the ER. Four ER's will provide a CDDS to the diagnosing physicians for specific periods (randomly and alternatingly allocated) in which physicians will be asked to use it for all included study patients. Outcomes between periods with and without the CDDS will be compared. Primary outcome is a diagnostic quality risk score composed of unscheduled ER revisits, unexpected hospitalization (both within 14 days), unexpected intensive medical care unit admission if hospitalized and diagnostic discrepancy between the ER discharge diagnosis and the current diagnosis after 14 days. In total, 1'184 patients will be included.
Detailed Description
Background: Misdiagnosis occurs in about 5% of outpatients, and in 10% to 35% of emergency room (ER) patients, sometimes with devastating medical and economic consequences. Nowadays, computerized diagnostic decision support programs (CDDS) exist, which suggest differential diagnoses (DDx) to physicians and thus have potential to improve diagnoses and hence, outcomes of patient care. The effects of such CDDS in 'real-world' ER settings are unknown. Controlled clinical trials investigating their effectiveness and safety are absent. In addition, most available CDDS are overcautious and suggest a wide variety of diagnostic options, likely increasing diagnostic resource consumption. Objectives: With this project, the investigators aim to understand the intended and unintended consequences of CDDS use by physicians on diagnostic quality and workflow in emergency medicine on the micro-level, how CDDS affect diagnostic quality by physicians in individual emergency patients. on the meso-level, how CDDS affect the diagnostic workflow in emergency departments. on the macro-level, the economic and educational impact of CDDS utilization in ERs Outcomes: Details given below Design: Cross sectional, multi-center, four-period cross-over controlled cluster-randomized trial. Four ER sites will randomly be allocated to one of two sequences with alternating intervention and control periods (ABAB vs. BABA) with each period lasting for two months. Recruitment will target 74 patients per period and cluster and 1'184 patients total. Inclusion / Exclusion Criteria: Details given below Intervention period: Details given below Control period: Details given below. Measurements and procedures: For the primary outcome, data will be extracted from the electronic health records (i.e. ER diagnosis, intensive care unit admission or diagnosis after 14d if patients are still hospitalized). Additionally, patients and their general practitioner will be contacted via telephone by study nurses after 14d of study inclusion in order to collect information about patients' current diagnoses, and re-visits or hospitalization related to the initial ER visit. Data for secondary endpoints will be retrieved from the routinely collected data in the electronic health record system (e.g mortality, time to ER diagnosis, resource consumption). Additionally, interviews and focus groups with physicians will be performed to investigate diagnostic workflow changes, physician confidence and other process outcomes. Statistical Analysis: Statistical analysis will be based on multi-level general linear mixed modelling (GLMM) methods using appropriate post hoc techniques (e.g for subgroup analyses). For the primary outcome (presence or no presence of a positive diagnostic quality risk score), a generalized linear mixed model (GLMM) with a binomial distribution family and exchangeable correlation structure will be performed. The GLMM takes into account a random effect for each site, resident and attending physician. Diagnosing resident and attending physicians are nested within sites. The condition (intervention and control) and the period (period 1 to 4) will be included as fixed factors under the assumption of equality of carry-over effects. Additionally, presenting chief complaint, patient's age, sex and comorbidity index will be added as covariates. For all secondary endpoints, summary statistics appropriate to the distribution will be tabulated by treatment group. Analysis of secondary endpoints will parallel the primary analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies, Diagnoses Disease
Keywords
Emergency, Diagnostic Error, Diagnostic Safety, Misdiagnosis, CDDS, Computerized Decision Support System, Diagnostic Quality

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cluster-Randomized Cross-Over Trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care + CDDS usage
Arm Type
Experimental
Arm Description
Patients presenting to the ER and included in the study during the ER's intervention period will be treated and diagnosed by the ER physicians as usual but with support of the CDDS.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients presenting to the ER and included in the study during the ER's intervention period will be treated and diagnosed by the ER physicians as usual without support of the CDDS.
Intervention Type
Device
Intervention Name(s)
Isabel Pro - The DDx generator (CDDS)
Intervention Description
Isabel Pro - the DDx generator is a software developped for health professionals with the intention to support them in broadening their differential diagnoses. After the first patient examination, the resident is asked to enter patient symptoms into Isabel Pro, which returns a list of possible diagnoses from its underlying database that matches the entered data. The diagnosing resident physicians will be asked to consult Isabel Pro at least once within the first hour after the first patient assessement. After entering patient symptoms into the software, Isabel Pro will itself return a list with possible diagnoses derived from their underlying database. It is then free to the physician to decide whether one or more of the suggested DDx should be considered for further diagnostic or treatment procedure based on clinical judgement.
Primary Outcome Measure Information:
Title
Diagnostic quality risk score
Description
Primary endpoint is a binary score indicating a diagnostic quality risk, composed of: Death within 14 days after emergency room discharge (yes/no) Unscheduled medical care (emergency room revisits, General Practitioner visits or hospitalization) within 14 days after emergency room discharge (yes/no) Unexpected intensive care unit admission from ward within 24 hours when hospitalized (yes/no) Diagnostic discrepancy between the emergency room discharge diagnosis and the current diagnosis 14 days after emergency room discharge (yes/no)
Time Frame
From emergency room discharge to 14 days after emergency room discharge
Secondary Outcome Measure Information:
Title
Death within 14 days after Emergency Room discharge (yes/no)
Description
Patient died within the timeframe of emergency discharge
Time Frame
From emergency room discharge to 14 days after emergency room discharge
Title
Unexpected intensive care unit admission
Description
Number of patients with unexpected intensive care unit admission from ward within 24 hours when hospitalized (yes/no)
Time Frame
Within 24 hours from emergency room transfer to hospital ward
Title
Diagnostic discrepancy
Description
Number of patients with diagnostic discrepancy between the Emergency Room discharge diagnosis and the current diagnosis 14 days after ER discharge (yes/no)
Time Frame
From emergency room discharge to 14 days after emergency room discharge
Title
Unscheduled medical care 72 hours, 7 days and 14 days
Description
Number of patients with unscheduled medical care 72 hours, 7 days and 14 days after emergency room discharge
Time Frame
From emergency room discharge to 72 hours, 7 days and 14 days after emergency room discharge
Title
Length of emergency room stay
Description
Number of hours the patient spent in emergency room routine care
Time Frame
Time from emergency room admission to emergency room discharge, up to 24 hours
Title
Length of hospital stay
Description
Number of days the patient was hospitalized (if hospitalized)
Time Frame
Time from hospital admission to hospital discharge, up to 18 days
Title
Diagnostic tests
Description
Number of diagnostic tests performed during emergency room routine care
Time Frame
Time from emergency room admission to emergency room discharge, up to 24 hours
Title
Resource consumption in the Emergency Department
Description
Resource consumption (total costs for personnel and diagnostics) during emergency room
Time Frame
Time from emergency room admission to emergency room discharge, up to 24 hours
Title
Resource consumption
Description
Resource consumption (total costs for personnel and diagnostics) during hospitalization
Time Frame
Time from emergency room admission to emergency room discharge, up to 18 days
Title
Discharge destination
Description
Home / Hospital (intern) / Hospital (extern) / Nursing home / Rehabilitation / Other
Time Frame
Timepoint of emergency room discharge (according to clinical routine, up to 24 hours)
Title
Number of differential diagnoses
Description
Number of differential diagnoses provided by the physicians at emergency room discharge
Time Frame
Timepoint of emergency room discharge (according to clinical routine, up to 24 hours)
Title
CDDS potential
Description
Number of cases where the generated differential diagnosis list entails the diagnoses after 14 days
Time Frame
Time from emergency room admission to 14 days after emergency room discharge
Title
Diagnostic error
Description
Diagnostic error based on full chart review for a random subset
Time Frame
From emergency room discharge to 14 days after emergency room discharge
Title
CDDS usage
Description
Number of CDDS queries
Time Frame
Time from emergency room admission to emergency room discharge From 0 up to 24 hours.
Title
Physician confidence calibration, advice seeking and collaboration
Description
Assessed by qualitative methods such as observations of physicians or interviews and focus groups with physicians (no patients directly involved).
Time Frame
Exact timepoints to be defined, up to a maximum of 9 months. From June 2022 to March 2023

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed Consent signed by the subject Presentation to the ER with fever, abdominal pain, syncope or Non-specific complaint (NSC) as chief complaint Triaged as "not vitally threatened" The study subject is 18 years old or older. Exclusion Criteria: Trauma as chief complaint Pregnancy Worsening of a known pre-existing condition or medical referral with a definite diagnosis Inability to follow the informed consent and investigation procedures Previous enrolment into the current investigation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolf Hautz, Prof. MD
Organizational Affiliation
Prof. MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of internal and emergency medicine, Spital Münsigen
City
Münsingen
State/Province
Bern
ZIP/Postal Code
3110
Country
Switzerland
Facility Name
Dept. of Internal and Emergency Medicine, Spital Tiefenau
City
Bern
ZIP/Postal Code
3004
Country
Switzerland
Facility Name
Dept. of Emergency Medicine, Inselspital, University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Dept. of Internal and Emergency Medicine, Buergerspital Solothurn
City
Solothurn
ZIP/Postal Code
3004
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Researchers who wish to use IPD for a nested study need to submit a proposal to the Sponsor-Investigator and request permission. A concept sheet describing the planned analyses must be approved by the sponsor-investigator and PIs of the participating sites. Nested studies might need separate ethics permission.

Learn more about this trial

Digitalized Differential Diagnosis Broadening in Emergency Rooms

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