Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013143
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Patient Profiling and Provider Feedback to Reduce Adverse Drug Events
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Patient Profiling and Provider Feedback to Reduce Adverse Drug Events
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None