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Completed

NCT Number: NCT05311670

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

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.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-reported outcomes monitoring

Behavioral

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

Other names: Survey

Primary outcomes

  1. Barriers to use of ePROs among patients

    Time frame: Up to one year (From one month after the study start until the thematic saturation is reached)

    Semi-structured interview with patients to evaluate ePRO use.

  2. Facilitators to use of ePROs among patients

    Time frame: Up to one year (From one month after the study start until the thematic saturation is reached)

    Semi-structured interview with patients to evaluate ePRO use.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: TSPRO2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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