Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-01 @ 5:24 PM
Study NCT ID:
NCT00789594
Status:
UNKNOWN
Last Update Posted:
2012-09-20
First Post:
2008-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Laboratory Monitoring in Community Practices: A Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-19', 'studyFirstSubmitDate': '2008-11-11', 'studyFirstSubmitQcDate': '2008-11-12', 'lastUpdatePostDateStruct': {'date': '2012-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Laboratory Monitoring', 'timeFrame': '6-months'}], 'secondaryOutcomes': [{'measure': 'Result management', 'timeFrame': '6-months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Monitoring', 'Testing', 'Medications', 'Patients receiving medications and having laboratory tests'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving care from clinicians at primary care and adult internal medicine specialty practices\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00789594', 'acronym': 'LabMon', 'briefTitle': 'Improving Laboratory Monitoring in Community Practices: A Randomized Trial', 'organization': {'class': 'FED', 'fullName': 'VA Boston Healthcare System'}, 'officialTitle': 'Improving Laboratory Monitoring in Community Practices: A Randomized Trial', 'orgStudyIdInfo': {'id': 'R18HS017201-01', 'link': 'https://reporter.nih.gov/quickSearch/R18HS017201-01', 'type': 'AHRQ'}, 'secondaryIdInfos': [{'id': 'R18HS017201-01', 'link': 'https://reporter.nih.gov/quickSearch/R18HS017201-01', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laboratory Monitoring', 'description': 'Laboratory Monitoring', 'interventionNames': ['Behavioral: laboratory monitoring alerts']}, {'type': 'EXPERIMENTAL', 'label': 'Result management', 'description': 'Result management', 'interventionNames': ['Behavioral: Result management module']}, {'type': 'EXPERIMENTAL', 'label': 'Both interventions', 'description': 'Both laboratory monitoring and result management interventions', 'interventionNames': ['Behavioral: laboratory monitoring alerts', 'Behavioral: Result management module']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care'}], 'interventions': [{'name': 'laboratory monitoring alerts', 'type': 'BEHAVIORAL', 'description': 'laboratory monitoring alerts', 'armGroupLabels': ['Both interventions', 'Laboratory Monitoring']}, {'name': 'Result management module', 'type': 'BEHAVIORAL', 'description': 'Result management module', 'armGroupLabels': ['Both interventions', 'Result management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Steven R Simon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Boston Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Boston Healthcare System', 'class': 'FED'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Steven Simon', 'investigatorAffiliation': 'VA Boston Healthcare System'}}}}