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
Gita Mody, MD
PRINCIPAL_INVESTIGATOR
MPH
CONTACT
NCT Number: NCT06075316
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.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
Location status: Recruiting
Amanda Gentry
CONTACT
Gita Mody, MD
PRINCIPAL_INVESTIGATOR
MPH
CONTACT
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.
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:
Exclusion criteria
All patients meeting any of the following exclusion criteria at enrollment will be excluded from study participation:
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.
Time frame: Months 4 through 6 after implementation of the study
Percentage of eligible thoracic surgery patients enrolling in 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
Time frame: Months 4 through 6 after implementation of the study
the percentage of enrolled patients who participate in >=1 ePRO survey.
Time frame: End of study
Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.
Time frame: Baseline through 30 days post-discharge
Percentage of participants with severe complications (Clavien-Dindo grade >=3)
Time frame: Baseline through 30 days post-discharge
Percentage of participants with an emergency department visit
Time frame: Baseline through 90 days post-discharge
Percentage of participants with an emergency department visit
Time frame: Baseline through 30 days post-discharge
Percentage participants readmitted to a hospital
Time frame: Baseline through 90 days post-discharge
Percentage participants readmitted to a hospital
Time frame: Baseline through 30 days
Percentage participants who died
Time frame: Baseline through 90 days
Percentage participants who died
Time frame: Baseline through 90 days
Percentage of all patients who trigger at least 1 alert.
Time frame: Baseline through 90 days
Percentage of all ePRO surveys that trigger an alert
Contact information is provided by the study sponsor or research team.
UNC Lineberger Comprehensive Cancer Center
Other
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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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