Overview

This trial is active, not recruiting.

Condition healthy
Treatments laboratory monitoring alerts, result management module
Sponsor VA Boston Healthcare System
Collaborator Agency for Healthcare Research and Quality (AHRQ)
Start date April 2009
End date June 2012
Trial size 50 participants
Trial identifier NCT00789594, R18 HS17201-01

Summary

The investigators propose a cluster-randomized controlled trial (RCT) of computerized point-of-care alerts in the EHR to prevent errors related to laboratory monitoring at the initiation and continuation of drug therapy and a results management system to prevent errors related to the delay in follow-up of abnormal laboratory testing.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Laboratory Monitoring
laboratory monitoring alerts
laboratory monitoring alerts
(Experimental)
Result management
result management module
Result management module
(Experimental)
Both laboratory monitoring and result management interventions
laboratory monitoring alerts
laboratory monitoring alerts
result management module
Result management module
(No Intervention)
Usual care

Primary Outcomes

Measure
Laboratory Monitoring
time frame: 6-months

Secondary Outcomes

Measure
Result management
time frame: 6-months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients receiving care from clinicians at primary care and adult internal medicine specialty practices Exclusion Criteria: - None

Additional Information

Official title Improving Laboratory Monitoring in Community Practices: A Randomized Trial
Principal investigator Steven R Simon, MD
Description Medication errors and preventable adverse drug events occur commonly among patients in the ambulatory setting and constitute an important target for patient safety and quality improvement. Laboratory monitoring to ensure the safety and effectiveness of drug therapy and the timely management of abnormal results of laboratory testing have been increasingly recognized as important areas for improving patient safety in ambulatory care. Promising interventions have been developed for practices affiliated with hospitals and integrated delivery systems, but efforts to date have not adequately reached physicians practicing solo or in small practices in the community. The Massachusetts e-Health Collaborative (MAeHC; www.maehc.org) provides an important opportunity to study implementation of healthcare information technology innovations in a community setting. In 2007, the MAeHC will complete the implementation of commercially available electronic health records (EHRs) for 441 physicians in more than 200 office practices in three diverse communities in Massachusetts. In this group of small-to-medium sized office practices in both urban and rural regions of the State, we will: 1) identify the barriers to and facilitators of laboratory monitoring and timely follow-up of abnormal laboratory results, especially for elderly patients and clinical scenarios common to this population; 2) design, implement and evaluate the effectiveness of clinical decision support (point-of-care alerts) for laboratory monitoring in a widely used, commercially available EHR; 3) design, implement and evaluate the effectiveness of a results management system to improve the timely follow-up of abnormal laboratory test results in office practice; 4) develop a practical dissemination guide to assist other practices and communities interested in implementing similar interventions. The results of this study will be important because they will demonstrate and accelerate the dissemination of clinicians' use of healthcare information technology to improve patient safety and healthcare quality beyond integrated delivery systems and should be broadly generalizable to small- and medium-sized office practices in community settings.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by VA Boston Healthcare System.