Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)

Not Applicable

Active, not recruiting

• Conditions: Thoracic

• Registration Number: NCT06075316
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

This is a single-site, non-randomized study on the outcomes of remote real-time "ePRO monitoring" in thoracic surgery patients. ePRO monitoring is a health information technology intervention comprised of delivering longitudinal electronic patient-reported outcome (ePRO) surveys (e.g., on symptoms, and physical functioning) coupled with automated provider alerts for concerning survey responses.

Detailed Description

Thoracic surgery patients are at high risk for severe complications post-surgery, such as respiratory failure, empyema, wound problems, and even mortality. Patients with complications may need readmission and invasive management. Usual care may not capture the symptoms of surgery complications. Well-designed remote monitoring of postoperative patients may enable early intervention and lower the risk of severe complications.

This study evaluates the implementation and effectiveness of perioperative electronic patient-reported outcomes (ePROs) monitoring in thoracic surgery patients. Previous studies demonstrated the feasibility of ePROs monitoring by thoracic surgery patients and providers. This study will explore barriers to implementation before real-world effectiveness studies.

Study Timeline

• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Study Start: 2023-11-14
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-19
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients participating in ePRO monitoring must meet the following inclusion criteria to participate in this study:

1. 18 years or older
2. English or Spanish speaking
3. Able to complete a web-based, telephonic (IVR), or CRA (or other IRB-approved research team member)-administrated symptom survey
4. Planned to undergo major thoracic surgery (involving chest wall incisions and overnight admission)
5. Discharged from the thoracic surgery service
6. Discharged to home

Exclusion Criteria

All patients meeting any of the following exclusion criteria at enrollment will be excluded from study participation:

1. Not completing planned surgery within 3 months of obtaining informed consent
2. Inability to understand English or Spanish
3. Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)
4. Dementia, altered mental status, or any psychiatric condition determined by the thoracic surgery provider team that would prohibit the understanding or rendering of informed consent.
5. Current incarceration
6. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reach of ePRO monitoring	Months 4 through 6 after implementation of the study	Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.
Adoption of ePRO monitoring	Months 4 through 6 after implementation of the study	Percentage of ePRO monitoring alerts sent that result in clinical action by providers within 1 week of delivery
Patient-level Uptake	Months 4 through 6 after implementation of the study	the percentage of enrolled patients who participate in \>=1 ePRO survey.
Overall Reach of ePRO monitoring	End of study	Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.

Secondary Outcome Measures

Name	Time	Method
Complication Rate	Baseline through 30 days post-discharge	Percentage of participants with severe complications (Clavien-Dindo grade \>=3)
Emergency department visit at 30 days	Baseline through 30 days post-discharge	Percentage of participants with an emergency department visit
Emergency department visit at 90 days	Baseline through 90 days post-discharge	Percentage of participants with an emergency department visit
Readmission at 30 days	Baseline through 30 days post-discharge	Percentage participants readmitted to a hospital
Readmission at 90 days	Baseline through 90 days post-discharge	Percentage participants readmitted to a hospital
Mortality at 30 days	Baseline through 30 days	Percentage participants who died
Mortality at 90 days	Baseline through 90 days	Percentage participants who died
Patient Alert Rate	Baseline through 90 days	Percentage of all patients who trigger at least 1 alert.
Alert Rate	Baseline through 90 days	Percentage of all ePRO surveys that trigger an alert

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States