Improving Laboratory Monitoring in Community Practices: A Randomized Trial

Healthy Clinical Trial

— LabMon  

Official title:

Improving Laboratory Monitoring in Community Practices: A Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00789594
• Other study ID #: R18HS017201-01
• Secondary ID: R18HS017201-01
• Status: Active, not recruiting
• Phase: N/A
• First received: November 11, 2008
• Last updated: September 19, 2012
• Start date: April 2009
• Est. completion date: March 2013

Study information

• Verified date: September 2012
• Source: VA Boston Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients receiving care from clinicians at primary care and adult internal medicine specialty practices

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• laboratory monitoring alerts
laboratory monitoring alerts
• Result management module
Result management module

Locations

Country	Name	City	State
United States	VA Boston Healthcare System	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
VA Boston Healthcare System	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory Monitoring		6-months	No
Secondary	Result management		6-months	No