Adverse Drug Events
Conditions
Keywords
Safety Management, Risk Management, surveillance, triggers
Brief summary
The purpose of this study is to determine if an electronic alerting technology improves time to intervention for possible ADEs, identify what factors affect adoption of ADE alerts, and whether there is a cost benefit associated with the alerting technology.
Detailed description
Inpatient adverse drug events (ADEs) continue to be a major source of morbidity and mortality despite advances in computerized drug safety measures. Reports on the ability of computerized ADE alerts to prevent and mitigate ADEs are lacking. The aims of this project are to 1) Assess organizational, social, and cognitive factors that affect adoption of real-time ADE alerting technology; 2) Analyze the effect of the ADE alerting technology on management and rate of ADEs; and 3) Estimate the cost-benefit of the ADE alerting technology. This study will use a patient randomized design of computerized real-time ADE alerts intended for primary and secondary prevention of ADEs. The ADE alerts promise to reduce mortality, morbidity, and costs due to ADEs. This study will quantify the effect of the alerts in the hands of first-year medical residents and pharmacists. The study will explore the associations of organizational and soci-cognitive barriers and facilitators with the adoption of the ADE alert technology. At the cognitive level, it will explore whether ADE Alerts change user bias in diagnosing ADEs or whether the alerts heighten sensitivity to drug problems.
Interventions
BEHAVIORALADE alert assistant
A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- All patients admitted to the SLCVAMC at time of study.
Exclusion criteria
\- There are no exclusions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Intervention Once an ADE Alert Has Fired in CPRS | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 297 |
| Arm 2: Control/No Alerts The second arm is the control. Alerts will not be displayed for these patients. | 298 |
| Total | 595 |
Baseline characteristics
| Characteristic | Arm 1: ADE Alerts | Arm 2: Control/No Alerts | Total |
|---|---|---|---|
| Age, Customized 18+ | 297 participants | 298 participants | 595 participants |
| Region of Enrollment United States | 297 participants | 298 participants | 595 participants |
| Sex/Gender, Customized Female or Male | NA participants | NA participants | NA participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 297 | 0 / 298 |
| serious Total, serious adverse events | 0 / 297 | 0 / 298 |
Outcome results
Primary
Time to Intervention Once an ADE Alert Has Fired in CPRS
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: ADE Alerts | Time to Intervention Once an ADE Alert Has Fired in CPRS | 6.8 hours to intervention |
| Arm 2: Control/No Alerts | Time to Intervention Once an ADE Alert Has Fired in CPRS | 8 hours to intervention |
p-value: 0.66895% CI: [0.7068, 1.249]Regression, Cox