Clinical trial NCT05311670: Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
Official title: Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Keywords: Electronic Patient-Reported Outcome
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects scheduled thoracic surgery at UNC Chapel Hill Hospital.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Barriers to use of ePROs among patients
timeFrame: Up to one year (From one month after the study start until the thematic saturation is reached)
measure: Facilitators to use of ePROs among patients
timeFrame: Up to one year (From one month after the study start until the thematic saturation is reached)
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gita Mody
role: PRINCIPAL_INVESTIGATOR
References: