Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS) (TSPRO2)

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery
• Intervention / Treatment: Behavioral: Patient-reported outcomes monitoring

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects scheduled thoracic surgery at UNC Chapel Hill Hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single-arm; Participants will be assigned to the single-arm involving monitoring of their symptoms.	Behavioral: Patient-reported outcomes monitoring; o Patient-reported outcomes will be collected from patients through web or telephone and alerts sent to providers.; Other Names: Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Gita Mody, University of North Carolina, Chapel Hill

Publications and helpful links

Helpful Links

• Clinical trials at UNC Lineberger

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Electronic Patient-Reported Outcome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection
• Other Study ID Numbers: LCCC 2202; 1K23HL157765-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan as of now to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No