Clinical trial NCT06075316: Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
Official title: Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Thoracic
Keywords: Electronic Patient-Reported Outcome
Patient-Reported Outcome
thoracic surgery
complications
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-10-10
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participants will have their alerts sent to the clinicians when concerning symptoms are reported.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reach of ePRO monitoring
timeFrame: Months 4 through 6 after implementation of the study
measure: Adoption of ePRO monitoring
timeFrame: Months 4 through 6 after implementation of the study
measure: Patient-level Uptake
timeFrame: Months 4 through 6 after implementation of the study
Secondary outcomes:
measure: Complication Rate
timeFrame: Baseline through 30 days post-discharge
measure: Emergency department visit at 30 days
timeFrame: Baseline through 30 days post-discharge
measure: Emergency department visit at 90 days
timeFrame: Baseline through 90 days post-discharge
measure: Readmission at 30 days
timeFrame: Baseline through 30 days post-discharge
measure: Readmission at 90 days
timeFrame: Baseline through 90 days post-discharge
measure: Mortality at 30 days
timeFrame: Baseline through 30 days
measure: Mortality at 90 days
timeFrame: Baseline through 90 days
measure: Patient Alert Rate
timeFrame: Baseline through 90 days
measure: Alert Rate
timeFrame: Baseline through 90 days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gita Mody, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: