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| ID | Type | Description | Link |
|---|---|---|---|
| R01LM009965 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Library of Medicine (NLM) | NIH |
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The utilization of clinical decision support (CDS) is increasing among healthcare facilities which have implemented computerized physician order entry or electronic medical records. Formal prospective evaluation of CDS implementations occurs rarely, and misuse or flaws in system design are often unrecognized. Retrospective review can identify failures but is too late to make critical corrections or initiate redesign efforts. A real-time surveillance dashboard for high-alert medications integrates externalized CDS interactions with relevant medication ordering, administration, and therapeutic monitoring data. The surveillance view of the dashboard displays all currently admitted, eligible patients and provides brief demographics with triggering order, laboratory, and CDS failure data to allow prioritization of high-risk scenarios. The patient detail view displays a detailed timeline of orders, order administrations, laboratory values, and CDS interactions for an individual patient and allows users to understand provider actions and patient condition changes occurring in conjunction with CDS failures. Clinical pharmacists' use of the dashboard for patient monitoring and intervention aims to increase the rate and timeliness of intercepted medication errors compared to CPOE-based CDS in the setting of acute kidney injury, which affects patients at various points across all hospital units and services and has numerous opportunities for intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dashboard | Experimental | Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions. |
|
| Control | No Intervention | Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacy Dashboard Review and Intervention | Other | Clinical pharmacist reviews patients on dashboard and makes intervention with providing team when necessary. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Drug Events or Potential Adverse Drug Events | Our primary outcome measured the rate of AKI-related ADEs and pADEs. We defined pADEs as incidents with the potential for injury related to a drug, such as use of a non-steroidal anti-inflammatory drug for at least 24 hours, and ADEs as injuries resulting from the administration of a drug, such as a toxic vancomycin trough level or a bleed after administration of enoxaparin. We measured outcomes after completion of the inpatient encounter (either by death or discharge); pADEs or ADEs occurring after patient discharge were not included in the analysis. | Until patient discharge (~2 week average) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Provider Response | Time from study event to modification or discontinuation of targeted medication | Until patient discharge (~2 week average) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison B McCoy, PhD | The University of Texas Health Science Center at Houston (UTHealth) | Principal Investigator |
| Josh F Peterson, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18999252 | Background | McCoy AB, Peterson JF, Gadd CS, Danciu I, Waitman LR. A system to improve medication safety in the setting of acute kidney injury: initial provider response. AMIA Annu Symp Proc. 2008 Nov 6:1051. |
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Patients who were dialyzed prior to the first serum creatinine change event or identified as a dialysis patient through a dialysis flag order, in addition to those admitted to renal transplant, liver transplant, or nephrology services were excluded.
We performed a randomized, controlled trial during June 1, 2010 through August 31, 2010 at a large academic, tertiary care facility. We included all admitted adult patients who experienced a 0.5 mg/dl change in serum creatinine over 48 hours following an active, recurring order for one or more targeted nephrotoxic or renally cleared medications.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dashboard | Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions. |
| FG001 | Control | Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dashboard | Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions. |
| BG001 | Control | Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Adverse Drug Events or Potential Adverse Drug Events | Our primary outcome measured the rate of AKI-related ADEs and pADEs. We defined pADEs as incidents with the potential for injury related to a drug, such as use of a non-steroidal anti-inflammatory drug for at least 24 hours, and ADEs as injuries resulting from the administration of a drug, such as a toxic vancomycin trough level or a bleed after administration of enoxaparin. We measured outcomes after completion of the inpatient encounter (either by death or discharge); pADEs or ADEs occurring after patient discharge were not included in the analysis. | Posted | Number | Patient-Medication Pairs | Until patient discharge (~2 week average) | Patient-Medication Pairs | Participants |
|
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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 | Dashboard | Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison B. McCoy, PhD | The University of Texas Health Science Center at Houston (UTHealth) | 713-500-6931 | allison.b.mccoy@uth.tmc.edu |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions. |
|
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| Secondary | Time to Provider Response | Time from study event to modification or discontinuation of targeted medication | Posted | Median | Inter-Quartile Range | Hours | Until patient discharge (~2 week average) | Patient-Medication Pairs | Participants |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control | Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions. | 0 | 0 | 0 | 0 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D064419 | Chemically-Induced Disorders |