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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06075316
Other study ID # LCCC 2141
Secondary ID 1K23HL157765-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date November 14, 2023
Est. completion date December 2026

Study information

Verified date January 2024
Source UNC Lineberger Comprehensive Cancer Center
Contact Amanda Gentry
Phone (336) 655-7743
Email Amanda_gentry@med.unc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2026
Est. primary completion date May 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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) or been discharged from thoracic surgery within the last 30 days from or by thoracic surgery service. Exclusion Criteria: All patients meeting any of the following exclusion criteria at enrollment will be excluded from study participation: 1. Not completing planned surgery within 3 months of obtaining informed consent 2. Inability to understand English or Spanish 3. Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy) 4. 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. 5. Current incarceration 6. Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Symptom 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.

Locations

Country Name City State
United States Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reach of ePRO monitoring Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring. Months 4 through 6 after implementation of the study
Primary 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
Secondary Complication Rate Percentage of participants with severe complications (Clavien-Dindo grade >=3) Baseline through 30 days post-discharge
Secondary Emergency department visit at 30 days Percentage of participants with an emergency department visit Baseline through 30 days post-discharge
Secondary Emergency department visit at 90 days Percentage of participants with an emergency department visit Baseline through 90 days post-discharge
Secondary Readmission at 30 days Percentage participants readmitted to a hospital Baseline through 30 days post-discharge
Secondary Readmission at 90 days Percentage participants readmitted to a hospital Baseline through 90 days post-discharge
Secondary Mortality at 30 days Percentage participants who died Baseline through 30 days
Secondary Mortality at 90 days Percentage participants who died Baseline through 90 days
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