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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: ADE Alerts | Experimental | 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 |
|
| Arm 2: Control/No Alerts | No Intervention | The second arm is the control. Alerts will not be displayed for these patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADE alert assistant | Behavioral | A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories. |
|
| Measure | Description | 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. |
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Inclusion Criteria:
- All patients admitted to the SLCVAMC at time of study.
Exclusion Criteria:
- There are no exclusions.
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan R. Nebeker, MD MS | VA Health Care Salt Lake City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Health Care Salt Lake City | Salt Lake City | Utah | 84148 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20686803 | Background | LaFleur J, McAdam-Marx C, Alder SS, Sheng X, Asche CV, Nebeker J, Brixner DI, Silverman SL. Clinical risk factors for fracture among postmenopausal patients at risk for fracture: a historical cohort study using electronic medical record data. J Bone Miner Metab. 2011 Mar;29(2):193-200. doi: 10.1007/s00774-010-0207-y. Epub 2010 Aug 6. | |
| 17909387 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Arm 2: Control/No Alerts | The second arm is the control. Alerts will not be displayed for these patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Intervention Once an ADE Alert Has Fired in CPRS | Posted | Median | Inter-Quartile Range | hours to intervention | 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. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director HSR&D | VA SLC HCS | 801-582-1565 | IDEAS@va.gov |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| Rupper RW, Bair BD, Sauer BC, Nebeker JR, Shinogle J, Samore M. Out-of-pocket pharmacy expenditures for veterans under medicare part D. Med Care. 2007 Oct;45(10 Supl 2):S77-80. doi: 10.1097/MLR.0b013e3180413871. |
| 18693944 | Result | Weir CR, Nebeker JR. Critical issues in an electronic documentation system. AMIA Annu Symp Proc. 2007 Oct 11;2007:786-90. |
| 17909388 | Result | Nebeker JR, Yarnold PR, Soltysik RC, Sauer BC, Sims SA, Samore MH, Rupper RW, Swanson KM, Savitz LA, Shinogle J, Xu W. Developing indicators of inpatient adverse drug events through nonlinear analysis using administrative data. Med Care. 2007 Oct;45(10 Supl 2):S81-8. doi: 10.1097/MLR.0b013e3180616c2c. |
| 20724395 | Result | Boockvar KS, Livote EE, Goldstein N, Nebeker JR, Siu A, Fried T. Electronic health records and adverse drug events after patient transfer. Qual Saf Health Care. 2010 Oct;19(5):e16. doi: 10.1136/qshc.2009.033050. Epub 2010 Aug 19. |
| 20513790 | Result | Kaafarani HM, Rosen AK, Nebeker JR, Shimada S, Mull HJ, Rivard PE, Savitz L, Helwig A, Shin MH, Itani KM. Development of trigger tools for surveillance of adverse events in ambulatory surgery. Qual Saf Health Care. 2010 Oct;19(5):425-9. doi: 10.1136/qshc.2008.031591. Epub 2010 May 31. |
| 19893849 | Result | Olola CH, Rowan B, Narus S, Smith M, Hastings T, Poynton M, Nebeker J, Hales J, Evans RS. Implementation of an emergency medical card and a continuity of care report using continuity of care standard. Methods Inf Med. 2009;48(6):519-30. doi: 10.3414/ME09-01-0003. Epub 2009 Nov 5. |
| BG001 | Arm 2: Control/No Alerts | The second arm is the control. Alerts will not be displayed for these patients. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | No demographics were collected including gender. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 297 |
| 0 |
| 297 |
| EG001 | Arm 2: Control/No Alert | The second arm is the control. Alerts will not be displayed for these patients. | 0 | 298 | 0 | 298 |
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