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 |
|---|---|---|---|---|---|---|---|---|
| Organize and Mobilize for Implementation Effectiveness | Our approach was based on the Implementation Sustainment Facilitation (ISF) and added discrete strategies from the Addiction Technology Transfer Center (ATTC), which were considered necessary elements from the original ISF trial. In addition to receiving the OEND best practice recommendations, our multi-component approach used external facilitation as the overarching strategy, by which seven other strategies were leveraged to support SSP staff and leadership. These included: organize implementation team meetings, identify and prepare champions, develop and organize quality monitoring system, assess for readiness and identify barriers, distribute educational materials and resources, conduct educational meetings, and provide ongoing consultation. Regarding potential dose, SSP staff and organizational leadership were provided the opportunity to participate in 60-minute sessions once a month for up to 12 months. In addition to monthly sessions, facilitators were provided up to 2 hours to prepare for sessions and to identify and distribute resources to SSPs based on identified priorities. All sessions were offered virtually over audio-visual connections. Thus, the maximum possible dose for each SSP was 12 sessions or 36 hours. | 0 | None | 0 | 51 | 0 | 51 | View |
| Dissemination of Best Practice Recommendations | Dissemination: Study staff disseminated best practice recommendations to all SSPs enrolled in the trial. To detail the OEND best practice recommendations, a Delphi study was carried out to develop a set of best practices for OEND implementation within SSPs. Experts for the Delphi study included people in paid and volunteer leadership and direct service positions in SSPs, OEND researchers, people who work in state or local health departments, and people who use drugs who deliver and access SSP/OEND services. All individuals had prior or current experience delivering OEND programming in community-based settings, and people with lived substance use experience were represented in each of the expert categories. Findings from this initiative were summarized into an organized best practices recommendations guide. | 0 | None | 0 | 51 | 0 | 51 | View |