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Evaluating the Use of an App in Pleural Disease: Algorithm-supported Clinical Decision Making Versus Usual Care (APPLAUS)

1 giugno 2026 aggiornato da: Uffe Bodtger, Zealand University Hospital

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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

828

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Danimarca
      • Aalborg, Danimarca, 9000
        • Aalborg University Hospital
      • Aarhus, Danimarca, 8200
        • Aarhus University Hospital
      • Amager, Danimarca, 2300
        • Amager Hospital
      • Esbjerg, Danimarca, 6700
        • Esbjerg Hospital
      • Hillerød, Danimarca, 3400
        • North Zealand Hospital, Hillerød
      • Hvidovre, Danimarca, 2650
        • Hvidovre Hospital
      • Kolding, Danimarca, 6000
        • Kolding Hospital
      • Køge, Danimarca, 4600
        • Zealand University Hospital, Køge
      • Odense, Danimarca, 5000
        • Odense University Hospital
      • Slagelse, Danimarca, 4200
        • Slagelse Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: Usual care
Care supported by a clinical decision-support tool delivered via a smartphone app.
Sperimentale: 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.
Comportamentale: Clinical 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Length of hospital stay (days)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Correct pneumothorax subtype classification
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Periprocedural
Chest tube size (French gauge, Fr) used for pleural effusion drainage
Periprocedural
Definitive cause for pleural effusion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Zealand University Hospital

Investigatori

  • Investigatore principale: Casper Jensen, MD, Lungemedicinsk Forskningsenhed (PLUZ), Institut for Regional Sundhedsforskning, Syddansk Universitet

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2026

Completamento primario (Stimato)

15 ottobre 2026

Completamento dello studio (Stimato)

15 ottobre 2026

Date di iscrizione allo studio

Primo inviato

20 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • p-2024-17577

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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