Patient Profiling and Provider Feedback to Reduce Adverse... | NCT00013143

Studies
Patient Profiling and Provider Feedback to Reduce Adverse Drug Events

NCT00013143

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Apr 7, 2015Estimated

Enrollment

1,200Estimated

Phase

Not Applicable

Conditions

Adverse Drug Events

Interventions

Patient risk profiling (potential ADEs) w/provider feedback

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Not provided

Completion Date

Jan 2003Actual

First Submitted Date

Mar 14, 2001

First Submission Date that Met QC Criteria

Mar 15, 2001

First Posted Date

Mar 16, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2015

Last Update Posted Date

Apr 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Adverse drug events (ADE) present a unique focus for error reduction. Computerized provider order entry, with embedded clinical decision support, has great promise in reducing medication errors but preventable adverse drug events may still occur despite such systems.

Detailed Description

Background:

Objectives:

The purpose of the study was to evaluate whether adding medication profiling (by using a retrospective drug utilization review program) to computerized provider order entry with embedded order checks (drug alerts) reduces the incidence of adverse drug events.

Methods:

Medication profiles mainly focused on possible drug-drug and drug-disease interactions, with some drug duplications. To do the medication profiles we licensed a proprietary computerized retrospective drug utilization review system. We randomly assigned over 900 patients to Usual Care or Provider Feedback. For patients in the latter group, selected providers were contacted by letter with pertinent information; electronic mail was used for follow-up contact. Clinical and other relevant data was retrospectively abstracted from the medical records for up to one year from the last medication profile for all patients. This was done by a pharmacist reviewer, using a study-derived instrument, and blinded to patient assignment. ADE incidence is the primary outcome of interest, with other outcomes such as ADE severity and preventability also assessed. We also developed and implemented provider surveys in pre- and post-profiling periods.

Status:

Pre and post survey results published. Adjunct study on clinical actions as a result of drug alerts published. Main study (profiling): manuscript in proces.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Other		Behavioral: Patient risk profiling (potential ADEs) w/provider feedback

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient risk profiling (potential ADEs) w/provider feedback	Behavioral		Arm 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient must be alive
patient must be currently active in GLA system
medication for which alert was generated must be currently active
patient provider must not be Peter Glassman

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter A. Glassman, MBBS MSc	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Greater Los Angeles Healthcare System, West Los Angeles, CA		West Los Angeles	California	90073	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16501396	Result	Glassman PA, Belperio P, Simon B, Lanto A, Lee M. Exposure to automated drug alerts over time: effects on clinicians' knowledge and perceptions. Med Care. 2006 Mar;44(3):250-6. doi: 10.1097/01.mlr.0000199849.08389.91.
12458299	Result	Glassman PA, Simon B, Belperio P, Lanto A. Improving recognition of drug interactions: benefits and barriers to using automated drug alerts. Med Care. 2002 Dec;40(12):1161-71. doi: 10.1097/00005650-200212000-00004.