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

• Sponsor: UNC Lineberger Comprehensive Cancer Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06075316
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42.5
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic	Other: Symptom monitoring	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The participants will have their alerts sent to the clinicians when concerning symptoms are reported.The participants will have their alerts sent to the clinicians when concerning symptoms are reported.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
• Anticipated Study Start Date: Oct 15, 2023
• Anticipated Primary Completion Date: Aug 1, 2026
• Anticipated Study Completion Date: May 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: ePRO monitoring Thoracic surgery patients will be enrolled in ePRO monitoring using web-based or telephone surveys.	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.

Outcome Measures

Primary Outcome Measures

1. Reach of ePRO monitoring [Months 4 through 6 after implementation of the study]

   Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.

2. 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

Secondary Outcome Measures

1. Complication Rate [Baseline through 30 days post-discharge]

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

2. Emergency department visit at 30 days [Baseline through 30 days post-discharge]

   Percentage of participants with an emergency department visit

3. Emergency department visit at 90 days [Baseline through 90 days post-discharge]

   Percentage of participants with an emergency department visit

4. Readmission at 30 days [Baseline through 30 days post-discharge]

   Percentage participants readmitted to a hospital

5. Readmission at 90 days [Baseline through 90 days post-discharge]

   Percentage participants readmitted to a hospital

6. Mortality at 30 days [Baseline through 30 days]

   Percentage participants who died

7. Mortality at 90 days [Baseline through 90 days]

   Percentage participants who died

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts 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) 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• UNC Lineberger Comprehensive Cancer Center
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Gita Mody, MD, MPH, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical trials at UNC Lineberger

Publications

None provided.

• Responsible Party: UNC Lineberger Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT06075316
• Other Study ID Numbers: LCCC 2141; 1K23HL157765-01A1
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by UNC Lineberger Comprehensive Cancer Center: Electronic Patient-Reported Outcome; Patient-Reported Outcome; thoracic surgery; complications
• Additional relevant MeSH terms: Aortic Dissection

Study Results

No Results Posted as of Oct 10, 2023