Digital Follow-up Program After Discharge Home Following Thoracic Surgery

Официальное название

The Development and Evaluation of a Digital Follow-up Program During the Initial Four Weeks After Discharge Home Following Thoracic Surgery. A Confirmatory, Single-center, Prospective, Non-blinded, Randomized, Controlled Study

Обзор

The aim of the study is to evaluate whether a digital follow-up program can improve postoperative pain management and quality of life in patients during the first 28 days after discharge home following thoracic surgery, compared to standard follow-up care.

Подробное описание

Thoracic surgery is essential for treating conditions such as thoracic malignancies, trauma, and chronic pulmonary diseases. While often life-saving, recovery after thoracic surgery can be challenging. Enhanced Recovery After Surgery (ERAS) programs have improved outcomes across surgical fields, but their impact on postoperative quality of life (QoL) in thoracic surgery is under-researched.

QoL post-surgery involves factors such as pain, physical and respiratory function, psychological well-being, and return to daily life. Effective communication between patients and their physicians post-discharge is crucial for early detection and management of complications.

Studies in other surgical areas (e.g., colorectal and cardiac surgery) have shown that mobile apps for follow-up can reduce emergency visits, readmissions, and improve patient experience. However, similar evidence is scarce in thoracic surgery. Existing studies suggest electronic patient-reported outcome (ePRO) systems could help monitor symptoms and improve care, but further research is needed.

Despite promising results in other specialties, there is limited evidence on the use of digital tools to monitor and support recovery after thoracic surgery. Given the importance of pain management, QoL, and preventing complications, the researchers aim to explore whether a digital follow-up program could offer measurable benefits for patients recovering at home.

The study aims to develop and evaluate a digital follow-up program for patients in the first 28 days after discharge home from thoracic surgery. The primary objective is to assess whether active, digital patient-physician communication can improve postoperative pain outcomes, compared to standard follow-up care.

Вмешательства

• Другое digital outpatient follow-up
  In addition to routine outpatient follow-up visits on day 14 and 28 post-operative, digital follow-up by questionnaire on their health status and general well-being are provided. Possibility to request an interaction with a doctor from our department at any time during the 28 days following discharge
• Другое standard follow-up
  routine outpatient follow-up visits on day 14 and 28 post-operative

Первичные конечные точки

• Subjective pain perception [Срок оценки: 4 weeks after discharge home]

Вторичные конечные точки (5)

• General well-being [Срок оценки: 4 weeks after discharge home]
• Post-Discharge documentation of analgesic use [Срок оценки: During the 4 weeks after discharge home]
• Emergency consultations [Срок оценки: During the 4 weeks after discharge home]
• Readmissions [Срок оценки: During the 4 weeks after discharge home]
• postoperative complications [Срок оценки: During the 4 weeks after discharge home]

Критерии участия

Критерии включения

• Patients who have signed an informed consent form and underwent a surgery performed at the Thoracic Surgery Department of the University Hospital Basel
• Age ≥ 18 years at the time of informed consent
• First participation in the Study
• Patient operated under general anesthesia
• Patients who are in possession of a smart phone or personal computer and have an e-mail account and are able to answer a digital questionnaire. Or an immediate caretaker in the same household owns a smartphone or personal computer and is familiar with the use
• Patients who understand verbal and written German or French
• Patients discharged at home after surgery
• Hospital stay > 3 nights after surgery

Критерии исключения

• Patients under preoperative opioid/cortisone therapy
• Patients who are unable to follow the procedure of the study, e. g. read or understand German or French, psychological disorders, dementia, etc.
• Enrolment of the investigator, his/her family members, employees and other dependent person
• Patients with polytrauma or who underwent mediastinoscopy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Швейцария · 1 центр

• University Hospital Basel — Basel

Идентификаторы

NCT: NCT07044440 · 2025-00796;kt25Lardinois3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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