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

2026년 6월 1일 업데이트: 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.

연구 개요

상태

초대로 등록

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

828

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
다른: Usual care
Care supported by a clinical decision-support tool delivered via a smartphone app.
실험적: 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.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Length of hospital stay (days)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Correct pneumothorax subtype classification
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: Periprocedural
Chest tube size (French gauge, Fr) used for pleural effusion drainage
Periprocedural
Definitive cause for pleural effusion
기간: 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
기간: 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
기간: 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.
기간: 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.
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Zealand University Hospital

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 1일

기본 완료 (추정된)

2026년 10월 15일

연구 완료 (추정된)

2026년 10월 15일

연구 등록 날짜

최초 제출

2026년 3월 20일

QC 기준을 충족하는 최초 제출

2026년 6월 1일

처음 게시됨 (실제)

2026년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 1일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • p-2024-17577

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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