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

NCT05311670 | Completed DMC

• 2 other identifiers: LCCC 22021K23HL157765-01A1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic Surgery

Keywords

Electronic Patient-Reported Outcome

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Single-arm

Participants will be assigned to the single-arm involving monitoring of their symptoms.

Behavioral: Patient-reported outcomes monitoring

Interventions

Patient-reported outcomes monitoring BEHAVIORAL

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

Also known as: Survey

Single-arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects scheduled thoracic surgery at UNC Chapel Hill Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gita Mody

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: April 5, 2022
• Study Start: April 7, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)