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

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic
• Intervention / Treatment: Other: Symptom monitoring

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

Contacts and Locations

• Study Contact: Name: Amanda Gentry; Phone Number: (336) 655-7743; Email: Amanda_gentry@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
      • Contact: Amanda Gentry; Phone Number: 919-966-3381; Email: amanda_gentry@med.unc.edu
      • Contact: MPH
      • Principal Investigator: Gita Mody, MD

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ePRO monitoring; Thoracic surgery patients will be enrolled in ePRO monitoring using web-based or telephone surveys.	Other: Symptom monitoring; Alerts will be sent to providers via email and/or the electronic medical record at pre-specified response thresholds. Providers will be instructed to respond to and document the management of alerts per their clinical routine.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Gita Mody, MD, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

Helpful Links

• Clinical trials at UNC Lineberger

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: complications; thoracic surgery; Patient-Reported Outcome; Electronic Patient-Reported Outcome
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: LCCC 2141; 1K23HL157765-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan as of now to make IPD available to other researchers.

Drug and device information, study documents

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