Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 7:25 PM
Study NCT ID:
NCT00115557
Status:
COMPLETED
Last Update Posted:
2010-08-12
First Post:
2005-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delivery of Preventive Services in Primary Care
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-11', 'studyFirstSubmitDate': '2005-06-23', 'studyFirstSubmitQcDate': '2005-06-26', 'lastUpdatePostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implementation of one or more of three evidence-based strategies', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Rates of delivery of selected preventive services', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['translational research', 'prevention', 'primary care', 'practice-based research network'], 'conditions': ['Preventive Services', 'Immunizations', 'Screening']}, 'descriptionModule': {'briefSummary': 'The major goal of this project is to determine the effectiveness of a multi-component intervention designed to help primary care practices implement three office system strategies known to increase delivery of immunizations and other preventive services. This two-year study will contribute to our understanding of multi-component translational interventions in primary care, and particularly within practice-based research networks.', 'detailedDescription': 'The multi-component translational intervention that we plan to test includes medical record audits with feedback and benchmarking, academic detailing by an opinion leader including information from literature review plus the advice of local exemplars, a practice facilitator, who will work with the practices over a six-month period, and an IT application that provides decision-support, prompts, and reminders to office staff and patients.\n\nThe proposed project will be a randomized controlled trial of a multi-component strategy designed to facilitate the incorporation into primary care practices of three office management components known to increase preventive service delivery rates: 1) nurse standing orders; 2) special immunization/ preventive services "clinics;" and 3) recall and reminder systems. Twenty-four practices, all members of a primary care practice-based research network, will be enrolled and randomized to receive the complete intervention or performance feedback with benchmarking only. The primary outcomes will be number of management components implemented. Characteristics of clinicians and practices that are associated with greater or lesser success in implementing the three strategies and barriers encountered will also be examined, and we will measure and compare rates of selected immunizations and preventive services delivered.\n\nThe specific aims for this project are to:\n\n1. Determine the effectiveness of a multi-component translational intervention on adoption of three strategies known to increase delivery of preventive services: nurse standing orders, a reminder/recall system (preferably PSRS), and special immunization and/or preventive services clinics. The intervention will include: a) performance feedback and benchmarking; b) training of clinicians and office staff in principles of effective preventive services (enhanced academic detailing by a physician opinion leader); c) practice enhancement assistants to facilitate office system changes; and d) an IT application that provides prompts and reminders to office staff, clinicians, and patients.\n2. Document contextual factors and barriers to the adoption of the three strategies and their impact on the intervention.\n3. Measure the impact of the intervention on rates of delivery of the following preventive services: DtaP#4, MMR#1, and HepB#3 in 2-3 year olds, and pneumococcal immunization, colorectal cancer screening, and mammography in adults 50 - 75 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary care physician\n* Member of the Oklahoma Physicians Resource/Research Network\n* Computer with internet connection\n* More than 30 patients seen per week\n* Provides care to 2-3 year-olds and/or 50-75 year olds\n\nExclusion Criteria:\n\n* Does not provide preventive services\n* Inclusion of more than two of the preventive service delivery strategies at baseline\n* Involved in another network project\n* Unwilling to work with an external practice facilitator\n* IRB used by the practice will not allow records audits without individual patient consent'}, 'identificationModule': {'nctId': 'NCT00115557', 'briefTitle': 'Delivery of Preventive Services in Primary Care', 'organization': {'class': 'FED', 'fullName': 'Agency for Healthcare Research and Quality (AHRQ)'}, 'officialTitle': 'Delivery of Preventive Services in Primary Care', 'orgStudyIdInfo': {'id': '1R21HS014850', 'link': 'https://reporter.nih.gov/quickSearch/1R21HS014850', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Performance feedback, academic detailing, practice facilitation, IT support', 'interventionNames': ['Other: Practice intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Performance feedback only', 'interventionNames': ['Other: Practice intervention 2']}], 'interventions': [{'name': 'Practice intervention', 'type': 'OTHER', 'description': 'Performance feedback, academic detailing, practice facilitation, IT support', 'armGroupLabels': ['1']}, {'name': 'Practice intervention 2', 'type': 'OTHER', 'description': 'Performance feedback only.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OKPRN', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'James W Mold, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'James Mold, MD, MPH', 'oldOrganization': 'University of Oklahoma HSC Department of Family and Preventive Medicine'}}}}