Improving Laboratory Monitoring in Community Practices: A Randomized Trial

NCT ID: NCT00789594

Last Updated: 2012-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-03-31

Brief 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.

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.

Conditions

Healthy

Keywords

Monitoring; Testing; Medications; Patients receiving medications and having laboratory tests

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Laboratory Monitoring

Laboratory Monitoring

Group Type: EXPERIMENTAL

laboratory monitoring alerts

Intervention Type: BEHAVIORAL

laboratory monitoring alerts

Result management

Result management

Group Type: EXPERIMENTAL

Result management module

Intervention Type: BEHAVIORAL

Result management module

Both interventions

Both laboratory monitoring and result management interventions

Group Type: EXPERIMENTAL

laboratory monitoring alerts

Intervention Type: BEHAVIORAL

laboratory monitoring alerts

Result management module

Intervention Type: BEHAVIORAL

Result management module

Usual care

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

laboratory monitoring alerts

laboratory monitoring alerts

Intervention Type: BEHAVIORAL

Result management module

Result management module

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

VA Boston Healthcare System

FED

Sponsor Role: lead

Responsible Party

Steven Simon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven R Simon, MD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System

Locations

VA Boston Healthcare System

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R18HS017201-01

Identifier Type: AHRQ

Identifier Source: secondary_id

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R18HS017201-01

Identifier Type: AHRQ

Identifier Source: org_study_id

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