NCT00780572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
595

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

November 18, 2015

Completed
Last Updated

December 21, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

October 24, 2008

Results QC Date

October 15, 2015

Last Update Submit

November 18, 2015

Conditions

Adverse Drug Events

Keywords

Safety ManagementRisk Managementsurveillancetriggers

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

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

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.

Interventions

ADE alert assistantBEHAVIORAL

A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories.

Arm 1: ADE Alerts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Health Care Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

Related Publications (7)

  • 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.

    PMID: 20686803BACKGROUND

  • 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.

    PMID: 17909387RESULT

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

    PMID: 18693944RESULT

  • 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.

    PMID: 17909388RESULT

  • 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.

    PMID: 20724395RESULT

  • 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.

    PMID: 20513790RESULT

  • 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.

    PMID: 19893849RESULT

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Results Point of Contact

Title
Director HSR&D
Organization
VA SLC HCS
IDEAS@va.gov
801-582-1565

Study Officials

  • Jonathan R. Nebeker, MD MS

    VA Health Care Salt Lake City

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 27, 2008

Study Start

December 1, 2008

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

December 21, 2015

Results First Posted

November 18, 2015

Record last verified: 2015-11

Locations

US(1)