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

NCT ID: NCT05311670

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-07

Study Completion Date

2022-10-10

Brief Summary

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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

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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.

Conditions

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Thoracic Surgery

Keywords

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Electronic Patient-Reported Outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single-arm

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

Patient-reported outcomes monitoring

Intervention Type BEHAVIORAL

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

Interventions

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Patient-reported outcomes monitoring

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Survey

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gita Mody

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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1K23HL157765-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC 2202

Identifier Type: -

Identifier Source: org_study_id