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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05311670
Acronym
TSPRO2
Enrollment
40
Registered
2022-04-05
Start date
2022-04-07
Completion date
2022-10-10
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgery

Keywords

Electronic Patient-Reported Outcome

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.

Interventions

BEHAVIORALPatient-reported outcomes monitoring

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Barriers to use of ePROs among patientsUp 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.
Facilitators to use of ePROs among patientsUp 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026