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Recruiting

NCT Number: NCT06075316

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.

Recruiting

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Amanda Gentry

CONTACT

[email protected]

919-966-3381

Gita Mody, MD

PRINCIPAL_INVESTIGATOR

MPH

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 18 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

Exclusion criteria

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Reach of ePRO monitoring

    Time frame: Months 4 through 6 after implementation of the study

    Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.

  2. Adoption of ePRO monitoring

    Time frame: 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

  3. Patient-level Uptake

    Time frame: Months 4 through 6 after implementation of the study

    the percentage of enrolled patients who participate in >=1 ePRO survey.

  4. Overall Reach of ePRO monitoring

    Time frame: End of study

    Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.

Secondary outcomes

  1. Complication Rate

    Time frame: Baseline through 30 days post-discharge

    Percentage of participants with severe complications (Clavien-Dindo grade >=3)

  2. Emergency department visit at 30 days

    Time frame: Baseline through 30 days post-discharge

    Percentage of participants with an emergency department visit

  3. Emergency department visit at 90 days

    Time frame: Baseline through 90 days post-discharge

    Percentage of participants with an emergency department visit

  4. Readmission at 30 days

    Time frame: Baseline through 30 days post-discharge

    Percentage participants readmitted to a hospital

  5. Readmission at 90 days

    Time frame: Baseline through 90 days post-discharge

    Percentage participants readmitted to a hospital

  6. Mortality at 30 days

    Time frame: Baseline through 30 days

    Percentage participants who died

  7. Mortality at 90 days

    Time frame: Baseline through 90 days

    Percentage participants who died

  8. Patient Alert Rate

    Time frame: Baseline through 90 days

    Percentage of all patients who trigger at least 1 alert.

  9. Alert Rate

    Time frame: Baseline through 90 days

    Percentage of all ePRO surveys that trigger an alert

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Gentry

CONTACT

[email protected]

(336) 655-7743

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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