Kidney Failure, AcuteNCT01134900
Achieving Medication Safety During Acute Kidney Injury
A study testing Pharmacy Dashboard Review and Intervention in people with Kidney Failure, Acute, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Acute
- What is being tested?
- Pharmacy Dashboard Review and Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 0.5 mg/dl increase or decrease in serum creatinine within 48 hours
- Active, recurring order for targeted renally cleared or nephrotoxic medication
Who cannot join
- Chronic dialysis
- Transplant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37235
About this study
Official title: Achieving Medication Safety During Acute Kidney Injury: The Impact of Clinical Decision Support and Real-Time Pharmacy Surveillance
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.
- Conditions
- Kidney Failure, Acute
- Being tested
- Pharmacy Dashboard Review and Intervention
- Keywords
- Medication Errors, Adverse Drug Events, Decision Support Systems, Clinical
- Medical subject headings
- Acute Kidney Injury, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacy Dashboard Review and InterventionOther
Clinical pharmacist reviews patients on dashboard and makes intervention with providing team when necessary.
| Study group | Role | What they receive |
|---|---|---|
| Dashboard | Experimental | Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions. Receives: Other: Pharmacy Dashboard Review and Intervention |
| Control | No intervention | Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until patient discharge (~2 week average)
Secondary outcomes (1)
Time to Provider Response
Time from study event to modification or discontinuation of targeted medication
Measured: Until patient discharge (~2 week average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Principal investigator, Allison McCoy, Vanderbilt University
- Investigators
- Allison B McCoy, PhD, Principal investigator, The University of Texas Health Science Center at Houston (UTHealth)Josh F Peterson, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134900
- Sponsor's protocol ID
- 081002
- Other IDs
- R01LM009965
- Status last verified
- Jan 2012
- First submitted
- 27 May 2010
- Last updated
- 27 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 18999252
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Medication Safety During Acute Kidney Injury: The Impact of Clinical Decision Support and Real-Time Pharmacy Surveillance
- ClinicalTrials.gov ID
- NCT01134900
- Acronym / sponsor ID
- 081002
- Conditions
- Kidney Failure, Acute
- Keywords
- Medication Errors, Adverse Drug Events, Decision Support Systems, Clinical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Posted 27 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dashboard | Experimental | Other: Pharmacy Dashboard Review and InterventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 0.5 mg/dl increase or decrease in serum creatinine within 48 hours
- Active, recurring order for targeted renally cleared or nephrotoxic medication
Key exclusion criteria (2 listed)
- Chronic dialysis
- Transplant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacy Dashboard Review and InterventionClinical pharmacist reviews patients on dashboard and makes intervention with providing team when necessary. | Other | Dashboard |
Primary outcome
Adverse Drug Events or Potential Adverse Drug Events
Time frame: 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.
1 secondary outcome
Time to Provider Response
Time frame: Until patient discharge (~2 week average)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18999252McCoy 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison B McCoy, PhD principal investigator
The University of Texas Health Science Center at Houston (UTHealth)
Josh F Peterson, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacy Dashboard Review and Intervention in people with Kidney Failure, Acute, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Drug Events or Potential Adverse Drug Events (time frame: Until patient discharge (~2 week average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01134900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2012.