OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the ED: Chest X-ray or CT

OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the ED: Chest X-ray or CT - The OPTIMACT trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45978

Enrollment

2400

Registered

2016-11-24

Start date

2017-01-18

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-traumatic pulmonary disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -> 18 years, -presenting at the Emergency department with a suspicion of non-traumatic pulmonary disease: with complaints of: dyspnoea, fever, chest pain or cough. -written informed consent for data collection

Exclusion criteria

Exclusion criteria: -incapacitated patiënts, -pregnant patiënts, -life expectancy less than one month, -patients with anticipated barriers to completing follow-up data collection, -patients who are not able to undergo a chest X-ray or chest CT, -earlier participation in this RCT.

Design outcomes

Primary

Measure	Time frame
- Functional health at 28 days measured by the physical summary scale of the SF-12. - Total health care costs during the first 28 days (healt care costs/iPCQ/iMCQ)	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints are: - Correct diagnosis at Emergency Department discharge (including use of other diagnosic measures if indicated), as confirmed by an independent adjucication committee at day 28. - Mental health (mental summary scale SF-12) - Length of hospital stay - Mortality within 28 days - Quality Adjusted Life Years during the first 28 days (EQ-5D-5L at 28 days) - Number of patients in follow-up because of incidental findings on chest X-ray or ULD chest CT Additional study parameters/endpoints for CAP sub-study - Correct diagnosis of CAP at Emergency department discharge, as confirmed by an independent adjudication committee at day 28 - Initial treatment decision (antibiotics yes/no) - Total antibiotic use over 28 days - Aetiology of pneumonia in patients with CAP and correlation of aetiology with results of chest X-ray and ULD chest CT - The role of biomarkers in the diagnosis of pneumonia and its correlation with the correct diagnosis of pneumonia confirmed by an independent adjudication committee at day 28.	—

Measure

Time frame

Secondary study parameters/endpoints are: - Correct diagnosis at Emergency Department discharge (including use of other diagnosic measures if indicated), as confirmed by an independent adjucication committee at day 28. - Mental health (mental summary scale SF-12) - Length of hospital stay - Mortality within 28 days - Quality Adjusted Life Years during the first 28 days (EQ-5D-5L at 28 days) - Number of patients in follow-up because of incidental findings on chest X-ray or ULD chest CT Additional study parameters/endpoints for CAP sub-study - Correct diagnosis of CAP at Emergency department discharge, as confirmed by an independent adjudication committee at day 28 - Initial treatment decision (antibiotics yes/no) - Total antibiotic use over 28 days - Aetiology of pneumonia in patients with CAP and correlation of aetiology with results of chest X-ray and ULD chest CT - The role of biomarkers in the diagnosis of pneumonia and its correlation with the correct diagnosis of pneumonia confirmed by an independent adjudication committee at day 28.

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Countries

Netherlands

Outcome results