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

ConditionThoracic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUNC Lineberger Comprehensive Cancer Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Symptom monitoring

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: ePRO monitoringOther 1 intervention

Trial outcomes

Primary outcomes

1

Reach of ePRO monitoring

Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.

Time frame
Months 4 through 6 after implementation of the study
2

Adoption of ePRO monitoring

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
3

Patient-level Uptake

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

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

Overall Reach of ePRO monitoring

Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.

Time frame
End of study

Secondary outcomes

1

Complication Rate

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

Time frame
Baseline through 30 days post-discharge
2

Emergency department visit at 30 days

Percentage of participants with an emergency department visit

Time frame
Baseline through 30 days post-discharge
3

Emergency department visit at 90 days

Percentage of participants with an emergency department visit

Time frame
Baseline through 90 days post-discharge
4

Readmission at 30 days

Percentage participants readmitted to a hospital

Time frame
Baseline through 30 days post-discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UNC Lineberger Comprehensive Cancer Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator