Pleural Diseases, Pleural Effusion, Pleural Infection, Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary
Conditions
Brief summary
Pleural disease is a group of conditions that affect the membrane around the lungs. These conditions-fluid around the lungs, infections, cancer, and collapsed lung-are common and can cause serious illness. They often lead to long hospital stays, emergency admissions, and reduced quality of life. In Denmark and worldwide, the number of patients with pleural disease is rising, and the treatment is costly for the healthcare system. How long patients stay in the hospital depends on the type of pleural disease. Some stay less than a week, while others remain for several weeks, especially if complications occur. Research shows that early diagnosis and treatment based on clinical guidelines can shorten hospital stays and improve outcomes. In the UK, many hospitals have created dedicated pleural clinics run by specialists. These clinics help ensure that patients receive fast, consistent, and evidence based care, and they have reduced the number of days patients spend in hospital. In Denmark, however, such clinics are rare. A recent national survey showed that many Danish hospitals do not follow current pleural disease guidelines, and many lack clear pathways for diagnosing and treating these patients. As a result, patients may receive suboptimal care. This project aims to close that gap. The goal is to develop an easy to use, guideline based decision tool that supports doctors in emergency, medical, and surgical departments. The tool will guide clinicians from the moment a patient arrives until discharge, helping them choose the right tests and treatments at the right time. By making expert knowledge accessible to non specialists, the project hopes to improve patient care, reduce complications, and shorten hospital stays. Ultimately, the project seeks to ensure that all patients with pleural disease in Denmark receive fast, safe, and evidence based treatment-no matter where they are admitted.
Interventions
BEHAVIORALClinical decision-making support tool
Care for patients with spontaneous pneumothorax, pleural effusion or pleural infection when supported by a clinical decision-support tool, in the form of a smartphone app.
OTHERUsual care
Care supported by a clinical decision-support tool delivered via a smartphone app.
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Stepped-wedge cluster-randomized controlled trial. All clusters begin in the control condition and cross over to the intervention at randomized time points.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
One or more of the following, relevante ICD-10 codes for either spontaneous pneumothorax, pleural effusion or pleural infection. Spontaneous pneumothorax: * DJ93 * DJ930 * DJ931 * DJ938 * DJ939 Pleural effusion: * DJ90 * DJ909 * DJ919 * DJ91 * DJ940 * DJ948 * DJ948A * DJ949 * DC782 Pleural infection: * DJ86 * DJ860 * DJ860
Exclusion criteria
* Traumatic pneumothorax (including iatrogenic pneumothorax) * Hemothorax
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay (days) | From hospital admission through hospital discharge (up to 90 days) | Number of days from hospital admission to hospital discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correct pneumothorax subtype classification | During index hospital admission (up to 90 days after admission) | Whether the pneumothorax subtype was correctly classified during the index hospital admission according to predefined diagnostic criteria (yes/no). |
| Number of participants receiving each initial pneumothorax management strategy | Within 24 hours from hospital admission | Number of participants managed with either conservative care, needle aspiration, chest tube insertion, or ambulatory device insertion |
| Chest tube size | Periprocedural. | Diameter of chest tube used for treatment of spontaneous pneumothorax, reported in French units (Fr). |
| Number of participants with persistent air leak (>7 days) | From chest tube insertion until resolution of air leak or up to 90 days | Number of participants with ongoing air leak through the chest drainage system for more than 7 days after chest tube insertion (yes/no) |
| Number of participants undergoing high-resolution computed tomography (HRCT) | During index hospital admission | Number of participants who underwent high-resolution computed tomography (HRCT) during hospital admission or within 90 days after discharge, recorded as yes/no |
| Number of participants receiving complete recommended diagnostic work-up for unilateral pleural effusion | At end of index hospital admission (up to 90 days). | Assessment of whether recommended blood tests (full blood count, C-reactive protein, renal function tests, liver function tests, and albumin) and pleural fluid analyses (pH or glucose, LDH, leukocyte differential count, microbiology culture and sensitivity analysis, and cytology) were performed in participants with unilateral pleural effusion. |
| Definitive cause for pleural effusion | During hospital admission or within 90 days after discharge. | Was a definitive cause for the cause of pleural effusion established. |
| Definitive pleural procedure | During hospital admission or within 90 days after discharge. | Definitive pleural procedure within 90 days of admission due to pleural effusion. |
| Number of participants receiving complete recommended diagnostic work-up for suspected pleural infection | Up to 90 days | Assessment of whether recommended blood tests (full blood count, C-reactive protein, renal function tests, liver function tests, and albumin) and pleural fluid analyses (pH or glucose, LDH, leukocyte differential count, microbiology culture and sensitivity analysis, and cytology) were performed in participants with suspected pleural infection. |
| Chest tube diameter of chest tubes used for pleural infection. | Periprocedural. | Diameter of chest tube used for drainage of pleural infection, reported in French units (Fr). |
| Number of participants receiving intrapleural enzyme therapy (IET) for pleural infection. | Up to 90 days. | Assessment of whether intrapleural enzyme therapy (IET) was administered in participants with pleural infection despite chest tube drainage. |
| Length of antibiotic treatment | During hospital admission or within 90 days after discharge. | Total length of antibiotic treatment (both intravenously and orally) for pleural infection. |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORCasper Jensen, MD
Lungemedicinsk Forskningsenhed (PLUZ), Institut for Regional Sundhedsforskning, Syddansk Universitet
Outcome results
None listed