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

Официальное название

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.

Обзор

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.

Вмешательства

• Поведенческое 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.
• Другое Usual care
  Care supported by a clinical decision-support tool delivered via a smartphone app.

Первичные конечные точки

• Length of hospital stay (days) [Срок оценки: From hospital admission through hospital discharge (up to 90 days)]

Вторичные конечные точки (12)

• Correct pneumothorax subtype classification [Срок оценки: During index hospital admission (up to 90 days after admission)]
• Number of participants receiving each initial pneumothorax management strategy [Срок оценки: Within 24 hours from hospital admission]
• Chest tube size [Срок оценки: Periprocedural.]
• Number of participants with persistent air leak (>7 days) [Срок оценки: From chest tube insertion until resolution of air leak or up to 90 days]
• Number of participants undergoing high-resolution computed tomography (HRCT) [Срок оценки: During index hospital admission]
• Number of participants receiving complete recommended diagnostic work-up for unilateral pleural effusion [Срок оценки: At end of index hospital admission (up to 90 days).]
• Chest tube size [Срок оценки: Periprocedural]
• Definitive cause for pleural effusion [Срок оценки: During hospital admission or within 90 days after discharge.]
• Definitive pleural procedure [Срок оценки: During hospital admission or within 90 days after discharge.]
• Number of participants receiving complete recommended diagnostic work-up for suspected pleural infection [Срок оценки: Up to 90 days]
• Chest tube diameter of chest tubes used for pleural infection. [Срок оценки: Periprocedural.]
• Number of participants receiving intrapleural enzyme therapy (IET) for pleural infection. [Срок оценки: Up to 90 days.]

Критерии участия

Критерии включения

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

Критерии исключения

• Traumatic pneumothorax (including iatrogenic pneumothorax)
• Hemothorax

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 10 центров

• 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
• … и ещё 2 центра

Идентификаторы

NCT: NCT07625176 · p-2024-17577

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗