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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL157765-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ePRO monitoring | Other | Thoracic surgery patients will be enrolled in ePRO monitoring using web-based or telephone surveys. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reach of ePRO monitoring | Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring. | Months 4 through 6 after implementation of the study |
| Adoption of ePRO monitoring | Percentage of ePRO monitoring alerts sent that result in clinical action by providers within 1 week of delivery | Months 4 through 6 after implementation of the study |
| Patient-level Uptake | the percentage of enrolled patients who participate in >=1 ePRO survey. | Months 4 through 6 after implementation of the study |
| Overall Reach of ePRO monitoring | Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring. | End of study |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | Percentage of participants with severe complications (Clavien-Dindo grade >=3) | Baseline through 30 days post-discharge |
| Emergency department visit at 30 days | Percentage of participants with an emergency department visit |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Gentry | Contact | (336) 655-7743 | Amanda_gentry@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gita Mody, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| Clinical trials at UNC Lineberger | View source |
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No plan as of now to make IPD available to other researchers.
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The participants will have their alerts sent to the clinicians when concerning symptoms are reported.
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| Baseline through 30 days post-discharge |
| Emergency department visit at 90 days | Percentage of participants with an emergency department visit | Baseline through 90 days post-discharge |
| Readmission at 30 days | Percentage participants readmitted to a hospital | Baseline through 30 days post-discharge |
| Readmission at 90 days | Percentage participants readmitted to a hospital | Baseline through 90 days post-discharge |
| Mortality at 30 days | Percentage participants who died | Baseline through 30 days |
| Mortality at 90 days | Percentage participants who died | Baseline through 90 days |
| Patient Alert Rate | Percentage of all patients who trigger at least 1 alert. | Baseline through 90 days |
| Alert Rate | Percentage of all ePRO surveys that trigger an alert | Baseline through 90 days |