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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,218
- 试验地点
- 8
- 主要终点
- Diagnostic quality risk score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Diagnostic quality risk score
时间窗: From emergency room discharge to 14 days after emergency room discharge
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)
次要结局
- Death within 14 days after Emergency Room discharge (yes/no)(From emergency room discharge to 14 days after emergency room discharge)
- Unexpected intensive care unit admission(Within 24 hours from emergency room transfer to hospital ward)
- Length of emergency room stay(Time from emergency room admission to emergency room discharge, up to 24 hours)
- Length of hospital stay(Time from hospital admission to hospital discharge, up to 18 days)
- Resource consumption in the Emergency Department(Time from emergency room admission to emergency room discharge, up to 24 hours)
- Diagnostic discrepancy(From emergency room discharge to 14 days after emergency room discharge)
- Unscheduled medical care 72 hours, 7 days and 14 days(From emergency room discharge to 72 hours, 7 days and 14 days after emergency room discharge)
- CDDS potential(Time from emergency room admission to 14 days after emergency room discharge)
- Diagnostic error(From emergency room discharge to 14 days after emergency room discharge)
- Diagnostic tests(Time from emergency room admission to emergency room discharge, up to 24 hours)
- Resource consumption(Time from emergency room admission to emergency room discharge, up to 18 days)
- Discharge destination(Timepoint of emergency room discharge (according to clinical routine, up to 24 hours))
- Number of differential diagnoses(Timepoint of emergency room discharge (according to clinical routine, up to 24 hours))
- CDDS usage(Time from emergency room admission to emergency room discharge From 0 up to 24 hours.)
- Physician confidence calibration, advice seeking and collaboration(Exact timepoints to be defined, up to a maximum of 9 months. From June 2022 to March 2023)