Adverse Drug EventsVA ADENCT00780572
Implementation of Real-time ADE Surveillance and Decision Support
A study testing ADE alert assistant in people with Adverse Drug Events, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Drug Events
- What is being tested?
- ADE alert assistant
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 595 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Mar 2011
- 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
- All patients admitted to the SLCVAMC at time of study.
Who cannot join
- There are no exclusions.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Health Care Salt Lake City
Salt Lake City, Utah, 84148
About this study
Official title: Implementation of Real-Time ADE Surveillance and Decision Support
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.
Read the 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.
- Conditions
- Adverse Drug Events
- Being tested
- ADE alert assistant
- Keywords
- Safety Management, Risk Management, surveillance, triggers
- Medical subject headings
- 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.
ADE alert assistantBehavioural
A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: ADE alert assistant |
| Arm 2: Control/No Alerts | No intervention | The second arm is the control. Alerts will not be displayed for these patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intervention Once an ADE Alert Has Fired in CPRS
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2010
- Study completionMar 2011
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 (7)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EventsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jonathan R. Nebeker, MD MS, Principal investigator, VA Health Care Salt Lake City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780572
- Sponsor's protocol ID
- IAB 05-224
- Acronym
- VA ADE
- Status last verified
- Nov 2015
- First submitted
- 24 Oct 2008
- Last updated
- 21 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20686803Rupper 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.
PubMed 17909387Weir CR, Nebeker JR. Critical issues in an electronic documentation system. AMIA Annu Symp Proc. 2007 Oct 11;2007:786-90.
PubMed 18693944Nebeker 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.
PubMed 17909388Boockvar 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.
PubMed 20724395Kaafarani 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.
PubMed 20513790Olola 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.
PubMed 19893849
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Real-Time ADE Surveillance and Decision Support
- ClinicalTrials.gov ID
- NCT00780572
- Acronym / sponsor ID
- VA ADE / IAB 05-224
- Conditions
- Adverse Drug Events
- Keywords
- Safety Management, Risk Management, surveillance, triggers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Dec 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 Oct 2008 (estimated)
- Results
- Posted 18 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: ADE Alerts | Experimental | Behavioral: ADE alert assistantArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the SLCVAMC at time of study.
Key exclusion criteria (1 listed)
- There are no exclusions.
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 |
|---|---|---|
| ADE alert assistantA note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories. | Behavioural | Arm 1: ADE Alerts |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20686803LaFleur 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.
- Results publication: PubMed 17909387Rupper 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.
- Results publication: PubMed 18693944Weir CR, Nebeker JR. Critical issues in an electronic documentation system. AMIA Annu Symp Proc. 2007 Oct 11;2007:786-90.
- Results publication: PubMed 17909388Nebeker 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.
- Results publication: PubMed 20724395Boockvar 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.
- Results publication: PubMed 20513790Kaafarani 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.
- Results publication: PubMed 19893849Olola 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.
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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.
Jonathan R. Nebeker, MD MS principal investigator
VA Health Care Salt Lake City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADE alert assistant in people with Adverse Drug Events, run by VA Office of Research and Development 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 1 inclusion and 1 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 21 Dec 2015. 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 18 Nov 2015). 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?
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.). 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 NCT00780572, which also lists 7 linked publications.
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 21 Dec 2015.