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

NCT07625176 | Enrolling By Invitation DMC

• 1 other identifier: p-2024-17577
• Study Type: interventional
• Target: 828
• Locations: 1 country
• Sites: 10

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.

Conditions

Pleural Diseases; Pneumothorax Spontaneous Primary; Pneumothorax Spontaneous Secondary; Pleural Effusion; Pleural Infection

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay (days)

  Number of days from hospital admission to hospital discharge.

  From hospital admission through hospital discharge (up to 90 days)

Secondary Outcomes (13)

• Correct pneumothorax subtype classification

  During index hospital admission (up to 90 days after admission)

• Number of participants receiving each initial pneumothorax management strategy

  Within 24 hours from hospital admission

• Chest tube size

  Periprocedural.

• 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 undergoing high-resolution computed tomography (HRCT)

  During index hospital admission

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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.

Other: Usual care

Clinical decision-making support tool

EXPERIMENTAL

Care supported by the clinical decision-making app. Clusters transition to this condition at predefined time points according to the stepped-wedge design.

Behavioral: Clinical decision-making support tool

Interventions

Clinical decision-making support tool BEHAVIORAL

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.

Clinical decision-making support tool

Usual care OTHER

Care supported by a clinical decision-support tool delivered via a smartphone app.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Traumatic pneumothorax (including iatrogenic pneumothorax)
• Hemothorax

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (10)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Amager Hospital

Amager, 2300, Denmark

Location

Esbjerg Hospital

Esbjerg, 6700, Denmark

Location

North Zealand Hospital, Hillerød

Hillerød, 3400, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Kolding Hospital

Kolding, 6000, Denmark

Location

Zealand University Hospital, Køge

Køge, 4600, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Slagelse Hospital

Slagelse, 4200, Denmark

Location

MeSH Terms

Conditions

Pleural Diseases; Pneumothorax; Pleural Effusion

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Casper Jensen, MD

  Lungemedicinsk Forskningsenhed (PLUZ), Institut for Regional Sundhedsforskning, Syddansk Universitet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stepped-wedge cluster-randomized controlled trial. All clusters begin in the control condition and cross over to the intervention at randomized time points.

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: June 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (10)