Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-07 @ 1:48 AM
Study NCT ID:
NCT00292968
Status:
COMPLETED
Last Update Posted:
2012-07-20
First Post:
2006-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D004327', 'term': 'Drinking Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5670}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-18', 'studyFirstSubmitDate': '2006-02-15', 'studyFirstSubmitQcDate': '2006-02-15', 'lastUpdatePostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health behaviors (diet, exercise, smoking status, and alcohol use', 'timeFrame': '4 and 9 months post intervention'}], 'secondaryOutcomes': [{'measure': "Intervention's Reach, Adoption, Implementation, Maintenance", 'timeFrame': 'At the time of delivery of care'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Health Behavior', 'Prevention', 'Informatics', 'Electronic Health Record'], 'conditions': ['Unhealthy Diet, Exercise, Smoking, and Alcohol Use']}, 'referencesModule': {'references': [{'pmid': '20453184', 'type': 'BACKGROUND', 'citation': 'Krist AH, Cifuentes M, Dodoo MS, Green LA. Measuring primary care expenses. J Am Board Fam Med. 2010 May-Jun;23(3):376-83. doi: 10.3122/jabfm.2010.03.090089.'}, {'pmid': '20338714', 'type': 'RESULT', 'citation': 'Wilson DB, Johnson RE, Jones RM, Krist AH, Woolf SH, Flores SK. Patient weight counseling choices and outcomes following a primary care and community collaborative intervention. Patient Educ Couns. 2010 Jun;79(3):338-43. doi: 10.1016/j.pec.2010.01.025. Epub 2010 Mar 24.'}, {'pmid': '20171538', 'type': 'RESULT', 'citation': 'Krist AH, Woolf SH, Johnson RE, Rothemich SF, Cunningham TD, Jones RM, Wilson DB, Devers KJ. Patient costs as a barrier to intensive health behavior counseling. Am J Prev Med. 2010 Mar;38(3):344-8. doi: 10.1016/j.amepre.2009.11.010.'}, {'pmid': '18929990', 'type': 'RESULT', 'citation': 'Dodoo MS, Krist AH, Cifuentes M, Green LA. Start-up and incremental practice expenses for behavior change interventions in primary care. Am J Prev Med. 2008 Nov;35(5 Suppl):S423-30. doi: 10.1016/j.amepre.2008.08.007.'}, {'pmid': '18929981', 'type': 'RESULT', 'citation': "Krist AH, Woolf SH, Frazier CO, Johnson RE, Rothemich SF, Wilson DB, Devers KJ, Kerns JW. An electronic linkage system for health behavior counseling effect on delivery of the 5A's. Am J Prev Med. 2008 Nov;35(5 Suppl):S350-8. doi: 10.1016/j.amepre.2008.08.010."}], 'seeAlsoLinks': [{'url': 'http://www.prescriptionforhealth.org/', 'label': 'Source of funding - Prescription for Health Innitiative'}, {'url': 'http://www.acorn.fap.vcu.edu/', 'label': 'Practice base research network study conducting the study - ACORN'}]}, 'descriptionModule': {'briefSummary': 'Using an electronic health record to link the resources of primary care practices and community programs will help patients to improve their diet and exercise, quit smoking, and moderate their drinking.', 'detailedDescription': 'We posit that practice systems to promote healthy behaviors must combine five attributes to be effective and sustainable. They must be comprehensive (addressing multiple behaviors and the "5 As"), flexible (offering options), generalizable to ordinary practices, practice-friendly (limiting burden), and apply the Chronic Care Model. We will test the effectiveness and implementation of an innovative "packaged" intervention with these features. Six ACORN-affiliated practices will adopt a brief (3 minute) routine to deliver A1-3 (Ask, Advise, Agree) in the office and to offer patients four options for intensive assistance (Assist \\[A4\\], Arrange \\[A5\\]) outside the office. Patients can select 9 months of online, telephone, or group counseling; or usual care. An electronic health record (EHR) will expedite the in-office intervention and referrals. Outcome measures will include health behaviors (derived from 7200 surveys administered pre-intervention and 3 and 9 months post-exposure) and implementation (derived from EHR data, "counselee" surveys, and patient/staff interviews). We hypothesize that implementing this novel "package" of interventions will be associated with improved health behaviors (using the Common Measures for physical activity, diet, smoking, and alcohol use). EHR-captured data will measure RE-AIM parameters, including Reach (14 sub-measures), Adoption, and Maintenance. Surveys and qualitative analysis of semi-structured interviews with patients and office staff will explore Implementation issues and suggested improvements. We hope to demonstrate that this innovative intervention not only promotes healthy behaviors but is feasible and sustainable in primary care. Accomplishing these goals requires a delicate balancing act--deploying evidence-based strategies that are effective in lifestyle change but limit demands for new staff, training, or time. We strike this balance by harnessing effective technologies and tools and by leveraging resources outside the practice. If our intervention helps patients change unhealthy behaviors and is appealing to ordinary practices, we envision the potential for widespread adoption and substantial population health benefits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll individuals over the age of 8 years presenting for care in 9 primary care practices\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT00292968', 'briefTitle': 'A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors', 'orgStudyIdInfo': {'id': '6268'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Computer based care', 'type': 'BEHAVIORAL'}, {'name': 'Telephone counseling', 'type': 'BEHAVIORAL'}, {'name': 'Group visits', 'type': 'BEHAVIORAL'}, {'name': 'Usual care', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23666', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Riverside Physicians Associates', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}], 'overallOfficials': [{'name': 'Alex Krist, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}, {'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}