Patient Profiling and Provider Feedback to Reduce Adverse Drug Events
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|ClinicalTrials.gov Identifier: NCT00013143|
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adverse Drug Events||Behavioral: Patient risk profiling (potential ADEs) w/provider feedback||Not Applicable|
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.
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.
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.
Pre and post survey results published. Adjunct study on clinical actions as a result of drug alerts published. Main study (profiling): manuscript in proces.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Patient Profiling and Provider Feedback to Reduce Adverse Drug Events|
|Study Start Date :||June 2001|
|Actual Study Completion Date :||January 2003|
|Arm 1||Behavioral: Patient risk profiling (potential ADEs) w/provider feedback|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013143
|United States, California|
|VA Greater Los Angeles Healthcare System, West Los Angeles, CA|
|West Los Angeles, California, United States, 90073|
|Principal Investigator:||Peter A. Glassman, MBBS MSc||VA Greater Los Angeles Healthcare System, West Los Angeles, CA|