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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Reach of ePRO monitoring [Срок оценки: Months 4 through 6 after implementation of the study]
• Adoption of ePRO monitoring [Срок оценки: Months 4 through 6 after implementation of the study]
• Patient-level Uptake [Срок оценки: Months 4 through 6 after implementation of the study]
• Overall Reach of ePRO monitoring [Срок оценки: End of study]

Вторичные конечные точки (9)

• Complication Rate [Срок оценки: Baseline through 30 days post-discharge]
• Emergency department visit at 30 days [Срок оценки: Baseline through 30 days post-discharge]
• Emergency department visit at 90 days [Срок оценки: Baseline through 90 days post-discharge]
• Readmission at 30 days [Срок оценки: Baseline through 30 days post-discharge]
• Readmission at 90 days [Срок оценки: Baseline through 90 days post-discharge]
• Mortality at 30 days [Срок оценки: Baseline through 30 days]
• Mortality at 90 days [Срок оценки: Baseline through 90 days]
• Patient Alert Rate [Срок оценки: Baseline through 90 days]
• Alert Rate [Срок оценки: Baseline through 90 days]

Критерии участия

Критерии включения

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)
• Discharged from the thoracic surgery service
• Discharged to home

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT06075316 · LCCC 2141 · 1K23HL157765-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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