Evaluating the Use of an App in Pleural Disease: Algorithm-supported Clinical Decision Making Versus Usual Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical decision-making support tool, Usual care.
- Who it may be relevant to
- Registry conditions: Pleural Diseases, Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary, Pleural Effusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Interventions
- Behavioral 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. - Other Usual care
Care supported by a clinical decision-support tool delivered via a smartphone app.
Primary outcome measures
- Length of hospital stay (days) [Time frame: From hospital admission through hospital discharge (up to 90 days)]
Secondary outcome measures (12)
- Correct pneumothorax subtype classification [Time frame: During index hospital admission (up to 90 days after admission)]
- Number of participants receiving each initial pneumothorax management strategy [Time frame: Within 24 hours from hospital admission]
- Chest tube size [Time frame: Periprocedural.]
- Number of participants with persistent air leak (>7 days) [Time frame: From chest tube insertion until resolution of air leak or up to 90 days]
- Number of participants undergoing high-resolution computed tomography (HRCT) [Time frame: During index hospital admission]
- Number of participants receiving complete recommended diagnostic work-up for unilateral pleural effusion [Time frame: At end of index hospital admission (up to 90 days).]
- Chest tube size [Time frame: Periprocedural]
- Definitive cause for pleural effusion [Time frame: During hospital admission or within 90 days after discharge.]
- Definitive pleural procedure [Time frame: During hospital admission or within 90 days after discharge.]
- Number of participants receiving complete recommended diagnostic work-up for suspected pleural infection [Time frame: Up to 90 days]
- Chest tube diameter of chest tubes used for pleural infection. [Time frame: Periprocedural.]
- Number of participants receiving intrapleural enzyme therapy (IET) for pleural infection. [Time frame: Up to 90 days.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 10 centers
- Aalborg University Hospital — Aalborg
- Aarhus University Hospital — Aarhus
- Amager Hospital — Amager
- Esbjerg Hospital — Esbjerg
- North Zealand Hospital, Hillerød — Hillerød
- Hvidovre Hospital — Hvidovre
- Kolding Hospital — Kolding
- Zealand University Hospital, Køge — Køge
- … and 2 more centers
Identifiers
NCT: NCT07625176 · p-2024-17577