Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Computer-Assisted Preoperative CBT Intervention | Patients will receive the computer-assisted preoperative CBT intervention (n=75). A particularly promising internet-based CBT pain program for the population of interest, PAINTrainer, demonstrated improved pain, function, coping and global health in patients with chronic knee arthritic pain in comparison to an internet education control, with benefits persisting for up to 52 weeks. In addition to the PAINTrainer, there will be an integration of a motivational interviewing (MI) intervention delivered by a trained "coach" across the sessions about (1) the benefits of opioid tapering for post-operative pain control, (2) approaches for safely tapering, (3) identifying and managing withdrawal symptoms patients may experience. Computer-Assisted Preoperative CBT Intervention (PAINTrainer): Subjects will be asked to complete eight (8) 30- to 45-minute educational sessions during the 4 weeks prior to your surgery. In addition to the computer based training sessions, there is a motivational interviewing component that requires subjects to meet with a member of the study team weekly for a total of four (4) 30- to 45-minute meetings to help manage opioid medication use. It is expected that subject participation in this arm of the study will be a total of 12 hours over the course of the entire study. | 0 | None | 0 | 20 | 0 | 20 | View |
| Treatment-as-usual (Control) | Patients scheduled to undergo total joint arthroplasty at the study site are automatically enrolled in a mandatory 4-hour education class delivered by a nurse educator or physical therapist. Utilizing an in-person Powerpoint presentation format, patients are informed about pre-habilitation exercises to do prior to surgery; what to expect the day of surgery; the multimodal analgesia protocol used in the perioperative period; options for anesthesia and analgesia; and the expectation of physical therapy after surgery. | 0 | None | 0 | 20 | 0 | 20 | View |