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

Thoracic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075316
• Other study ID #: LCCC 2141
• Secondary ID: 1K23HL157765-01A
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aortic Dissection
• Thoracic

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

External Links

•   Clinical trials at UNC Lineberger