Evaluating the Use of an App in Pleural Disease: Algorithm-supported Clinical Decision Making Versus Usual Care (APPLAUS)
Evaluating the Use of an App in Pleural Disease: Algorithm-supported Clinical Decision Making Versus Usual Care: a Multicentre, Stepped-wedge Cluster-randomised Controlled Trial to Reduce Number of Days in Hospital.
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
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Aalborg, Dania, 9000
- Aalborg University Hospital
-
Aarhus, Dania, 8200
- Aarhus University Hospital
-
Amager, Dania, 2300
- Amager Hospital
-
Esbjerg, Dania, 6700
- Esbjerg Hospital
-
Hillerød, Dania, 3400
- North Zealand Hospital, Hillerød
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Hvidovre, Dania, 2650
- Hvidovre Hospital
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Kolding, Dania, 6000
- Kolding Hospital
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Køge, Dania, 4600
- Zealand University Hospital, Køge
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Odense, Dania, 5000
- Odense University Hospital
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Slagelse, Dania, 4200
- Slagelse Hospital
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Usual care
Usual provided care for patients with spontaneous pneumothorax, pleural effusion or pleural infection. All clusters begin in this condition before transitioning to the intervention as part of the stepped-wedge schedule. |
Care supported by a clinical decision-support tool delivered via a smartphone app.
|
|
Eksperymentalny: Clinical decision-making support tool
Care supported by the clinical decision-making app.
Clusters transition to this condition at predefined time points according to the stepped-wedge design.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Length of hospital stay (days)
Ramy czasowe: From hospital admission through hospital discharge (up to 90 days)
|
Number of days from hospital admission to hospital discharge.
|
From hospital admission through hospital discharge (up to 90 days)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Correct pneumothorax subtype classification
Ramy czasowe: 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).
|
During index hospital admission (up to 90 days after admission)
|
|
Number of participants receiving each initial pneumothorax management strategy
Ramy czasowe: Within 24 hours from hospital admission
|
Number of participants managed with either conservative care, needle aspiration, chest tube insertion, or ambulatory device insertion
|
Within 24 hours from hospital admission
|
|
Chest tube size
Ramy czasowe: Periprocedural.
|
Diameter of chest tube used for treatment of spontaneous pneumothorax, reported in French units (Fr).
|
Periprocedural.
|
|
Number of participants with persistent air leak (>7 days)
Ramy czasowe: 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)
|
From chest tube insertion until resolution of air leak or up to 90 days
|
|
Number of participants undergoing high-resolution computed tomography (HRCT)
Ramy czasowe: 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
|
During index hospital admission
|
|
Number of participants receiving complete recommended diagnostic work-up for unilateral pleural effusion
Ramy czasowe: 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.
|
At end of index hospital admission (up to 90 days).
|
|
Chest tube size
Ramy czasowe: Periprocedural
|
Chest tube size (French gauge, Fr) used for pleural effusion drainage
|
Periprocedural
|
|
Definitive cause for pleural effusion
Ramy czasowe: During hospital admission or within 90 days after discharge.
|
Was a definitive cause for the cause of pleural effusion established.
|
During hospital admission or within 90 days after discharge.
|
|
Definitive pleural procedure
Ramy czasowe: During hospital admission or within 90 days after discharge.
|
Definitive pleural procedure within 90 days of admission due to pleural effusion.
|
During hospital admission or within 90 days after discharge.
|
|
Number of participants receiving complete recommended diagnostic work-up for suspected pleural infection
Ramy czasowe: 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.
|
Up to 90 days
|
|
Chest tube diameter of chest tubes used for pleural infection.
Ramy czasowe: Periprocedural.
|
Diameter of chest tube used for drainage of pleural infection, reported in French units (Fr).
|
Periprocedural.
|
|
Number of participants receiving intrapleural enzyme therapy (IET) for pleural infection.
Ramy czasowe: Up to 90 days.
|
Assessment of whether intrapleural enzyme therapy (IET) was administered in participants with pleural infection despite chest tube drainage.
|
Up to 90 days.
|
|
Length of antibiotic treatment
Ramy czasowe: During hospital admission or within 90 days after discharge.
|
Total length of antibiotic treatment (both intravenously and orally) for pleural infection.
|
During hospital admission or within 90 days after discharge.
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Casper Jensen, MD, Lungemedicinsk Forskningsenhed (PLUZ), Institut for Regional Sundhedsforskning, Syddansk Universitet
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- p-2024-17577
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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