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Implementation of Real-time ADE Surveillance and Decision Support (VA ADE)

Primary Purpose

Adverse Drug Events

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADE alert assistant
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adverse Drug Events focused on measuring Safety Management, Risk Management, surveillance, triggers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- All patients admitted to the SLCVAMC at time of study.

Exclusion Criteria:

- There are no exclusions.

Sites / Locations

  • VA Health Care Salt Lake City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1: ADE Alerts

Arm 2: Control/No Alerts

Arm Description

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

The second arm is the control. Alerts will not be displayed for these patients.

Outcomes

Primary Outcome Measures

Time to Intervention Once an ADE Alert Has Fired in CPRS

Secondary Outcome Measures

Full Information

First Posted
October 24, 2008
Last Updated
November 18, 2015
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00780572
Brief Title
Implementation of Real-time ADE Surveillance and Decision Support
Acronym
VA ADE
Official Title
Implementation of Real-Time ADE Surveillance and Decision Support
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Events
Keywords
Safety Management, Risk Management, surveillance, triggers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
595 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: ADE Alerts
Arm Type
Experimental
Arm Description
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 Title
Arm 2: Control/No Alerts
Arm Type
No Intervention
Arm Description
The second arm is the control. Alerts will not be displayed for these patients.
Intervention Type
Behavioral
Intervention Name(s)
ADE alert assistant
Intervention Description
A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - All patients admitted to the SLCVAMC at time of study. Exclusion Criteria: - There are no exclusions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan R. Nebeker, MD MS
Organizational Affiliation
VA Health Care Salt Lake City
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Health Care Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20686803
Citation
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.
Results Reference
background
PubMed Identifier
17909387
Citation
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.
Results Reference
result
PubMed Identifier
18693944
Citation
Weir CR, Nebeker JR. Critical issues in an electronic documentation system. AMIA Annu Symp Proc. 2007 Oct 11;2007:786-90.
Results Reference
result
PubMed Identifier
17909388
Citation
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.
Results Reference
result
PubMed Identifier
20724395
Citation
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.
Results Reference
result
PubMed Identifier
20513790
Citation
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.
Results Reference
result
PubMed Identifier
19893849
Citation
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.
Results Reference
result

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Implementation of Real-time ADE Surveillance and Decision Support

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