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

NCT06075316 | Recruiting DMC

• 2 other identifiers: LCCC 21411K23HL157765-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic

Keywords

Electronic Patient-Reported Outcome; Patient-Reported Outcome; thoracic surgery; complications

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Complication Rate

  Baseline through 30 days post-discharge

• Emergency department visit at 30 days

  Baseline through 30 days post-discharge

• Emergency department visit at 90 days

  Baseline through 90 days post-discharge

• Readmission at 30 days

  Baseline through 30 days post-discharge

• Readmission at 90 days

  Baseline through 90 days post-discharge

Study Arms (1)

ePRO monitoring

OTHER

Thoracic surgery patients will be enrolled in ePRO monitoring using web-based or telephone surveys.

Other: Symptom monitoring

Interventions

Symptom monitoring OTHER

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.

ePRO monitoring

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not completing planned surgery within 3 months of obtaining informed consent
• Inability to understand English or Spanish
• Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)
• 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.
• Current incarceration
• Pregnancy

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• Clinical trials at UNC Lineberger

Study Officials

• Gita Mody, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Gentry

CONTACT

(336) 655-7743; Amanda_gentry@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants will have their alerts sent to the clinicians when concerning symptoms are reported.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: November 14, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)