Trial Outcomes & Findings for Implementation of Real-time ADE Surveillance and Decision Support (NCT NCT00780572)
NCT ID: NCT00780572
Last Updated: 2015-12-21
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
595 participants
Primary outcome timeframe
From the time an ADE alert fires in CPRS until the time action has been taken, i.e. an order placed, up to 24 hours.
Results posted on
2015-12-21
Participant Flow
Participant milestones
| Measure |
Arm 1: ADE Alerts
Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group
ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories.
|
Arm 2: Control/No Alerts
The second arm is the control. Alerts will not be displayed for these patients.
|
|---|---|---|
|
Overall Study
STARTED
|
297
|
298
|
|
Overall Study
COMPLETED
|
297
|
298
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementation of Real-time ADE Surveillance and Decision Support
Baseline characteristics by cohort
| Measure |
Arm 1: ADE Alerts
n=297 Participants
Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group
ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories.
|
Arm 2: Control/No Alerts
n=298 Participants
The second arm is the control. Alerts will not be displayed for these patients.
|
Total
n=595 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18+
|
297 participants
n=5 Participants
|
298 participants
n=7 Participants
|
595 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female or Male
|
NA participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
Region of Enrollment
United States
|
297 participants
n=5 Participants
|
298 participants
n=7 Participants
|
595 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the time an ADE alert fires in CPRS until the time action has been taken, i.e. an order placed, up to 24 hours.Outcome measures
| Measure |
Arm 1: ADE Alerts
n=297 Participants
Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group
ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories.
|
Arm 2: Control/No Alerts
n=298 Participants
The second arm is the control. Alerts will not be displayed for these patients.
|
|---|---|---|
|
Time to Intervention Once an ADE Alert Has Fired in CPRS
|
6.8 hours to intervention
Interval 1.4 to 25.5
|
8 hours to intervention
Interval 1.7 to 42.0
|
Adverse Events
Arm 1: ADE Alerts
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Control/No Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place