Thoracic
Conditions
Keywords
Electronic Patient-Reported Outcome, Patient-Reported Outcome, thoracic surgery, complications
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.
Detailed description
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.
Interventions
OTHERSymptom monitoring
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.
Sponsors
UNC Lineberger Comprehensive Cancer Center
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The participants will have their alerts sent to the clinicians when concerning symptoms are reported.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Patients participating in ePRO monitoring must meet the following inclusion criteria to participate in this study: 1. 18 years or older 2. English or Spanish speaking 3. Able to complete a web-based, telephonic (IVR), or CRA (or other IRB-approved research team member)-administrated symptom survey 4. Planned to undergo major thoracic surgery (involving chest wall incisions and overnight admission) 5. Discharged from the thoracic surgery service 6. Discharged to home
Exclusion criteria
All patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach of ePRO monitoring | Months 4 through 6 after implementation of the study | Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring. |
| Adoption of ePRO monitoring | 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 |
| Patient-level Uptake | Months 4 through 6 after implementation of the study | the percentage of enrolled patients who participate in \>=1 ePRO survey. |
| Overall Reach of ePRO monitoring | End of study | Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate | Baseline through 30 days post-discharge | Percentage of participants with severe complications (Clavien-Dindo grade \>=3) |
| Emergency department visit at 30 days | Baseline through 30 days post-discharge | Percentage of participants with an emergency department visit |
| Emergency department visit at 90 days | Baseline through 90 days post-discharge | Percentage of participants with an emergency department visit |
| Readmission at 30 days | Baseline through 30 days post-discharge | Percentage participants readmitted to a hospital |
| Readmission at 90 days | Baseline through 90 days post-discharge | Percentage participants readmitted to a hospital |
| Mortality at 30 days | Baseline through 30 days | Percentage participants who died |
| Mortality at 90 days | Baseline through 90 days | Percentage participants who died |
| Patient Alert Rate | Baseline through 90 days | Percentage of all patients who trigger at least 1 alert. |
| Alert Rate | Baseline through 90 days | Percentage of all ePRO surveys that trigger an alert |
Countries
United States
Contacts
CONTACTAmanda Gentry
PRINCIPAL_INVESTIGATORGita Mody, MD, MPH
University of North Carolina, Chapel Hill
Outcome results
None listed