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

1. juni 2026 opdateret af: 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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

828

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv 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.
Andet: Usual care
Care supported by a clinical decision-support tool delivered via a smartphone app.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length of hospital stay (days)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correct pneumothorax subtype classification
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Periprocedural
Chest tube size (French gauge, Fr) used for pleural effusion drainage
Periprocedural
Definitive cause for pleural effusion
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zealand University Hospital

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2026

Primær færdiggørelse (Anslået)

15. oktober 2026

Studieafslutning (Anslået)

15. oktober 2026

Datoer for studieregistrering

Først indsendt

20. marts 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • p-2024-17577

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Pleurale sygdomme

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