About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Symptom monitoring
Other interventionAlerts 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.
Treatment groups
Trial outcomes
Primary outcomes
Reach of ePRO monitoring
Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.
Adoption of ePRO monitoring
Percentage of ePRO monitoring alerts sent that result in clinical action by providers within 1 week of delivery
Patient-level Uptake
the percentage of enrolled patients who participate in \>=1 ePRO survey.
Overall Reach of ePRO monitoring
Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.
Secondary outcomes
Complication Rate
Percentage of participants with severe complications (Clavien-Dindo grade \>=3)
Emergency department visit at 30 days
Percentage of participants with an emergency department visit
Emergency department visit at 90 days
Percentage of participants with an emergency department visit
Readmission at 30 days
Percentage participants readmitted to a hospital
Sponsors and contacts
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UNC Lineberger Comprehensive Cancer Center
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator