Digital Follow-up Program After Discharge Home Following Thoracic Surgery (DFP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Surgery; Post Operative Recovery; Mobile Health; Follow-up
• Intervention / Treatment: Other: digital outpatient follow-up; Other: standard follow-up

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zeljko Djakovic, MD; Phone Number: +41 61 328 51 96; Email: zeljko.djakovic@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Zeljko Djakovic, MD; Phone Number: +41 61 328 51 96; Email: zeljko.djakovic@usb.ch
    • Principal Investigator: Zeljko Djakovic, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: digital follow-up; digital follow-up by questionnaire in addition to routine follow-up	Other: 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
Active Comparator: standard follow-up; routine follow-up	Other: standard follow-up; routine outpatient follow-up visits on day 14 and 28 post-operative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective pain perception	Impact on the subjective pain perception is assessed by the numeric rating scale (NRS). Scale ranges from 0-10 while 10 indicates more pain	4 weeks after discharge home

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General well-being	General well-being is assessed by the numeric rating scale (NRS). Scale ranges from 0-10 while 10 indicates better outcome	4 weeks after discharge home
Post-Discharge documentation of analgesic use	Assessment of any analgesics admitted after discharge home	During the 4 weeks after discharge home
Emergency consultations	Number of emergency consultations within 4 weeks after discharge home	During the 4 weeks after discharge home
Readmissions		During the 4 weeks after discharge home
postoperative complications	postoperative complications after hospital discharge home according to the Clavien-Dindo Classification of surgical complications	During the 4 weeks after discharge home

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Didier Lardinois, Prof. MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 16, 2025
• First Submitted That Met QC Criteria: June 25, 2025
• First Posted (Actual): July 1, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Thoracic Surgery; Electronic Follow-up
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: 2025-00796;kt25Lardinois3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No