Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)

Thoracic Surgery Clinical Trial

— TSPRO2  

Official title:

Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05311670
• Other study ID #: LCCC 2202
• Secondary ID: 1K23HL157765-01A
• Status: Completed
• Start date: April 7, 2022
• Est. completion date: October 10, 2022

Study information

• Verified date: December 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the LCCC 2202 is to evaluate the barriers and facilitators to implementing perioperative "ePRO monitoring". This study will inform a future hybrid effectiveness study (LCCC 2141:Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS). Eligible thoracic surgery patients will be enrolled to ePRO monitoring using web-based or telephone surveys. Patients will be asked to self-report symptoms for remote monitoring by their care team. Patients will be approached for a semi-structured interview to understand the barriers and facilitators to ePRO use.

Description:

This is a single-site, non-randomized study in patients receiving major thoracic surgery, which commonly involves chest wall incisions and overnight admission Eligible patients will be approached at any time point between their preoperative clinic visit and up to 30 days after discharge from the hospital. Approximately 60 patients will be enrolled in the study. Patients will complete symptom surveys via email or telephone. Concerning symptoms will generate alerts for the clinical care team who will follow their usual protocols for the management of symptoms. Patients will be purposively selected and invited to participate in a semi-structured interview to understand their experience using ePRO. Interviews will continue until 30 complete interviews are obtained and/or thematic saturation is reached.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 18 years or older
• English speaking
• Able and willing to complete a web-based or telephonic symptom survey
• Planned to undergo surgery within 90 days or have undergone and been discharged from major thoracic surgery within the last 30 days.

Exclusion Criteria:

• Not completing planned surgery within 3 months of obtaining informed consent (for subjects recruited preoperatively)
• Inability to read and speak English
• Planned for foregut surgery (e.g. paraesophageal hernia repair, esophageal resection or repair)
• Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)
• Dementia, altered mental status, or any psychiatric condition as determined by thoracic surgery provider team that would prohibit the understanding or rendering of informed consent.
• Current incarceration
• Pregnancy

Related Conditions & MeSH terms

• Aortic Dissection
• Thoracic Surgery

Intervention

Behavioral:
• Patient-reported outcomes monitoring
o Patient-reported outcomes will be collected from patients through web or telephone and alerts sent to providers.

Locations

Country	Name	City	State
United States	University of North Carolina at 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	Barriers to use of ePROs among patients	Semi-structured interview with patients to evaluate ePRO use.	Up to one year (From one month after the study start until the thematic saturation is reached)
Primary	Facilitators to use of ePROs among patients	Semi-structured interview with patients to evaluate ePRO use.	Up to one year (From one month after the study start until the thematic saturation is reached)

External Links

•   Clinical trials at UNC Lineberger