Clinical trial NCT00235027: Improving Safety By Computerizing Outpatient Prescribing
Official title: Improving Safety By Computerizing Outpatient Prescribing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impact of Electronic Prescribing on Medication Safety
Lead sponsor: Agency for Healthcare Research and Quality (AHRQ)
Sponsor class: FED
First posted: 2005-10-10
Enrollment: 701
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patient safety is at the forefront of critical issues in health care. Medications are the single most frequent cause of adverse events, and in the inpatient setting adverse drug events (ADEs) are common, expensive, injurious to patients, and often preventable. Relatively little, however, is known about the frequency of ADEs in the ambulatory setting, how to monitor for outpatient ADEs, or on the impact of prevention strategies such as computerization of prescribing supplemented by decision-support.

Detailed description: Specific Aim 1: Increase routine identification of outpatient adverse drug events (ADEs) through development of a computerized ADE detection monitor.

Specific Aim 2: Use basic computerized outpatient prescribing to reduce preventable ADEs in a diverse array of outpatient settings.

Specific Aim 3: Use advanced decision-support within computerized prescribing to reduce the frequency of preventable ADEs, medication errors, and potential ADEs.

Eligibility criteria: Inclusion Criteria: At Brigham \& Women's Hospital, clinics utilizing the electronic medical record will be included. At Regenstrief, any clinic that has access to their electronic medical record will be utilized.

* For the impact of basic decision support, clinics were not randomized
* For impact of advanced decision support, clinics were randomized to receive the intervention

Exclusion Criteria:

* Clinics not using electronic medical records

Primary outcomes:
measure: Preventable Adverse drug events
timeFrame: 8/5/2004 - 1/5/2005
Secondary outcomes:
measure: Total adverse drug events, medication errors
timeFrame: 1/15/2001 - 5/15/2001
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Regenstrief/Indiana University
state: Indiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Tejal K Gandhi, MD, MPH
role: STUDY_DIRECTOR
affiliation: Brigham and Women's Hospital
name: David Bates, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regenstrief Institute, Inc.
name: Marc Overhage, MD
role: STUDY_DIRECTOR
References:
citation: Shah NR, Seger AC, Seger DL, Fiskio JM, Kuperman GJ, Blumenfeld B, Recklet EG, Bates DW, Gandhi TK. Improving acceptance of computerized prescribing alerts in ambulatory care. J Am Med Inform Assoc. 2006 Jan-Feb;13(1):5-11. doi: 10.1197/jamia.M1868. Epub 2005 Oct 12.
citation: Gandhi TK, Seger AC, Overhage JM, Murray MD, Hope C, Fiskio J, Teal E, Bates DW. Outpatient adverse drug events identified by screening electronic health records. J Patient Saf. 2010 Jun;6(2):91-6. doi: 10.1097/PTS.0b013e3181dcae06.