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 |
|---|---|---|---|---|---|---|---|---|
| Direct Intervention | Initial Evaluation: Prior to discharge, the care coordinator will review the hospital discharge plan, obtain the approval of the patient's physicians to co-manage the patient's care, and schedule a visit at the place of discharge. Participants receive direct interaction with a care coordinator to develop an individualized care plan. Frequent assessments will occur to continue to follow or to modify the care plan based on the needs of the patient. At the end of 6 months, all patients will be transitioned to full care by their primary care and specialty physicians and their participation in this study will be ended. Care Coordinator Intervention for Direct Intervention Group: The coordinator will conduct a visit within 72 hours of discharge to assess the physical, cognitive, and psychological status, and will complete a needs assessment for both the patient and family caregiver. These will be used to guide the care protocols and development of the individualized care plan. The care plan is developed with an emphasis on coordinating services with the patient's providers. During the second visit, the individualized care plan is reviewed with the patient and family caregiver and revisions are made based on assessment outcomes. The 6-month Interaction Period: The coordinator and participant meet to revisit the care plan and to facilitate care. At the end of 6 months, all patients are transitioned to full care by their primary care and specialty physicians. | 7 | None | 0 | 20 | 0 | 20 | View |
| Standard of Care | Prior to hospital discharge, the care coordinator will identify the primary care and/or hepatology provider of patients in the usual care group and will ensure follow up appointments at the time of hospital discharge. The coordinator will compose and send a letter to the primary care and/or hepatology provider summarizing the patient's diagnosis, hospital course, discharge medications, and the plan of follow-up care. If the patient does not already have a primary care or hepatology provider, the coordinator will work with the patient to identify a new provider. Subjects in this group will receive no further intervention. Care Coordinator Intervention for Standard of Care Group: For participants randomized to this arm, a consultation with the care team will be arranged prior to hospital discharge. Outcome measures will be obtained by blinded research staff from all enrolled subjects at baseline, 3 months, and 6 months. This is the extent of interventions received for participants in this arm. | 6 | None | 0 | 20 | 0 | 20 | View |
| Caregiver | The caregivers of people with cirrhosis will be enrolled in the study. They will complete the assessments at baseline, 3 months and 6 months. Caregiver Intervention: Caregivers of the participants will be assessed for caregiver burden at 3 time points. | 0 | None | 0 | 4 | 0 | 4 | View |