Implementation of Real-time ADE Surveillance and Decision Support

Adverse Drug Events Clinical Trial

— VA ADE  

Official title:

Implementation of Real-Time ADE Surveillance and Decision Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780572
• Other study ID #: IAB 05-224
• Status: Completed
• Phase: N/A
• First received: October 24, 2008
• Last updated: November 18, 2015
• Start date: December 2008
• Est. completion date: March 2011

Study information

• Verified date: November 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 595
• Est. completion date: March 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• There are no exclusions.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Adverse Drug Events
• Drug-Related Side Effects and Adverse Reactions

Intervention

Behavioral:
• ADE alert assistant
A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories.

Locations

Country	Name	City	State
United States	VA Health Care Salt Lake City	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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 Su — View 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- — View 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. — View Citation

Weir CR, Nebeker JR. Critical issues in an electronic documentation system. AMIA Annu Symp Proc. 2007 Oct 11:786-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Intervention Once an ADE Alert Has Fired in CPRS		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.	Yes