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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Thoracic

Intervention / Treatment
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* Other: Symptom monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients participating in ePRO monitoring must meet the following inclusion criteria to participate in this study: 18 years or older English or Spanish speaking Able to complete a web-based, telephonic (IVR), or CRA (or other IRB-approved research team member)-administrated symptom survey 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: Not completing planned surgery within 3 months of obtaining informed consent Inability to understand English or Spanish Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy) 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. Current incarceration Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: The participants will have their alerts sent to the clinicians when concerning symptoms are reported.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ePRO monitoring<br>Thoracic surgery patients will be enrolled in ePRO monitoring using web-based or telephone surveys. | Other: Symptom monitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complications, Electronic Patient-Reported Outcome, Patient-Reported Outcome, thoracic surgery