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Sponsors and Collaborators: |
Harvard Pilgrim Health Care Agency for Healthcare Research and Quality (AHRQ) |
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Information provided by: | Harvard Pilgrim Health Care |
ClinicalTrials.gov Identifier: | NCT00789594 |
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 |
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Healthy |
Behavioral: laboratory monitoring alerts Behavioral: Result management module |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Factorial Assignment |
Official Title: | Improving Laboratory Monitoring in Community Practices: A Randomized Trial |
Estimated Enrollment: | 50 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Laboratory Monitoring: Experimental
Laboratory Monitoring
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Behavioral: laboratory monitoring alerts
laboratory monitoring alerts
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Result management: Experimental
Result management
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Behavioral: Result management module
Result management module
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Both interventions: Experimental
Both laboratory monitoring and result management interventions
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Behavioral: laboratory monitoring alerts
laboratory monitoring alerts
Behavioral: Result management module
Result management module
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Usual care: No Intervention
Usual care
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Steven R Simon, MD | 617-509-9938 | steven_simon@hphc.org |
United States, Massachusetts | |
Harvard Pilgrim Health Care | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Steven R Simon, MD | Harvard Pilgrim Health Care |
Responsible Party: | Harvard Pilgrim Health Care ( Steven R. Simon, Principal Investigator ) |
Study ID Numbers: | R18 HS17201-01, R18 HS17201-01 |
Study First Received: | November 11, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00789594 |
Health Authority: | United States: Institutional Review Board |
Monitoring Testing Medications Patients receiving medications and having laboratory tests |
Healthy |