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
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT04601506
Description:
Adverse events not collected
Frequency Threshold:
5
Time Frame:
Adverse events not collected
Study:
NCT04601506
Study Brief:
PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Primary Care Providers
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Care as Usual | Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing. | 0 | None | 0 | 0 | 0 | 0 | View |
| Choice Architecture Nudge | Clinics in this arm will receive the choice architecture nudge intervention. Choice Architecture Nudge: Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options. PCPs will also be sent alerts when they initiate an opioid order for a patient will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be. The alert contains options to either cancel the refill order, or to continue with the order. | 0 | None | 0 | 0 | 0 | 0 | View |
| PMP Integration & Nudge | Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention. PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient. | 0 | None | 0 | 0 | 0 | 0 | View |
| Choice Architecture Nudge + PMP Integration & Nudge | Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions. Choice Architecture Nudge: Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance and prompts open the "SmartSet" to order non-opioid treatment alternatives. PCPs will also be sent alerts when they initiate an opioid order for a patient will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be. PMP Integration \& Nudge: During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient. | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Other Events(If Any):