Kidney Failure, Acute
Conditions
Keywords
Medication Errors, Adverse Drug Events, Decision Support Systems, Clinical
Brief summary
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.
Interventions
OTHERPharmacy Dashboard Review and Intervention
Clinical pharmacist reviews patients on dashboard and makes intervention with providing team when necessary.
Sponsors
National Library of Medicine (NLM)
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 0.5 mg/dl increase or decrease in serum creatinine within 48 hours * Active, recurring order for targeted renally cleared or nephrotoxic medication
Exclusion criteria
* Chronic dialysis * Transplant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Drug Events or Potential Adverse Drug Events | Until patient discharge (~2 week average) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Provider Response | Until patient discharge (~2 week average) | Time from study event to modification or discontinuation of targeted medication |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Dashboard Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions. | 200 |
| Control Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions. | 196 |
| Total | 396 |
Baseline characteristics
| Characteristic | Control | Dashboard | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 76 Participants | 89 Participants | 165 Participants |
| Age, Categorical Between 18 and 65 years | 120 Participants | 111 Participants | 231 Participants |
| Age Continuous | 58.3 years STANDARD_DEVIATION 15.7 | 60.7 years STANDARD_DEVIATION 16.8 | 59.5 years STANDARD_DEVIATION 16.3 |
| Region of Enrollment United States | 196 participants | 200 participants | 396 participants |
| Sex: Female, Male Female | 77 Participants | 94 Participants | 171 Participants |
| Sex: Female, Male Male | 119 Participants | 106 Participants | 225 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Until patient discharge (~2 week average)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dashboard | Adverse Drug Events or Potential Adverse Drug Events | 99 Patient-Medication Pairs |
| Control | Adverse Drug Events or Potential Adverse Drug Events | 104 Patient-Medication Pairs |
Secondary
Time to Provider Response
Time from study event to modification or discontinuation of targeted medication
Time frame: Until patient discharge (~2 week average)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dashboard | Time to Provider Response | Ordered Prior to AKI | 23.7 Hours |
| Dashboard | Time to Provider Response | Ordered After AKI | 42.37 Hours |
| Control | Time to Provider Response | Ordered Prior to AKI | 27.31 Hours |
| Control | Time to Provider Response | Ordered After AKI | 43.83 Hours |