Improving Laboratory Monitoring in Community Practices: A Randomized Trial (LabMon)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by VA Boston Healthcare System.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Simon, VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT00789594
First received: November 11, 2008
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Healthy
Behavioral: laboratory monitoring alerts
Behavioral: Result management module

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Laboratory Monitoring in Community Practices: A Randomized Trial

Further study details as provided by VA Boston Healthcare System:

Primary Outcome Measures:
  • Laboratory Monitoring [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Result management [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2009
Estimated Study Completion Date: March 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laboratory Monitoring
Laboratory Monitoring
Behavioral: laboratory monitoring alerts
laboratory monitoring alerts
Experimental: Result management
Result management
Behavioral: Result management module
Result management module
Experimental: Both interventions
Both laboratory monitoring and result management interventions
Behavioral: laboratory monitoring alerts
laboratory monitoring alerts
Behavioral: Result management module
Result management module
No Intervention: Usual care
Usual care

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00789594

Locations
United States, Massachusetts
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Boston Healthcare System
Investigators
Principal Investigator: Steven R Simon, MD VA Boston Healthcare System
  More Information

No publications provided

Responsible Party: Steven Simon, Principal Investigator, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT00789594     History of Changes
Other Study ID Numbers: R18 HS17201-01, R18 HS17201-01
Study First Received: November 11, 2008
Last Updated: September 19, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by VA Boston Healthcare System:
Monitoring
Testing
Medications
Patients receiving medications and having laboratory tests

ClinicalTrials.gov processed this record on October 01, 2014