Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-29 @ 5:11 PM
Study NCT ID:
NCT01108432
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2010-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DPBRN Hygienists Internet Quality Improvement in Tobacco Cessation (HiQuit)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-24', 'studyFirstSubmitDate': '2010-04-20', 'studyFirstSubmitQcDate': '2010-04-20', 'lastUpdatePostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of smokers referred to tobacco cessation website', 'timeFrame': '12 months', 'description': 'We will asses the number of patient referrals that the dental hygienists make to the tobacco cessation website.'}], 'secondaryOutcomes': [{'measure': 'Proportion of smokers who go to the tobacco cessation website', 'timeFrame': '12 months', 'description': 'We will assess the proportion of smokers who were referred to the tobacco cessation website to the number of patients who registered on the website.'}, {'measure': 'Point prevalence smoking cessation', 'timeFrame': '6 months', 'description': 'Tobacco cessation behaviors will be assessed by follow-up email and/or telephone interviews at six months from website enrollment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tobacco cessation counseling'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '33605440', 'type': 'DERIVED', 'citation': 'Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.'}, {'pmid': '24439349', 'type': 'DERIVED', 'citation': 'Ray MN, Funkhouser E, Williams JH, Sadasivam RS, Gilbert GH, Coley HL, Rindal DB, Houston TK; National Dental PBRN Collaborative Group. Smoking-cessation e-referrals: a national dental practice-based research network randomized controlled trial. Am J Prev Med. 2014 Feb;46(2):158-65. doi: 10.1016/j.amepre.2013.10.018.'}, {'pmid': '24139766', 'type': 'DERIVED', 'citation': 'Coley HL, Sadasivam RS, Williams JH, Volkman JE, Schoenberger YM, Kohler CL, Sobko H, Ray MN, Allison JJ, Ford DE, Gilbert GH, Houston TK; National Dental PBRN and QUITPRIMO Collaborative Group. Crowdsourced peer- versus expert-written smoking-cessation messages. Am J Prev Med. 2013 Nov;45(5):543-50. doi: 10.1016/j.amepre.2013.07.004.'}]}, 'descriptionModule': {'briefSummary': 'Our overall goal is to advance science related to using the Internet in health services delivery, and specifically smoking cessation by targeting dental hygienists. Our proposed intervention is the first Internet-delivered intervention to target the dental microsystem for smoking cessation-providing access to hygienists and patients.', 'detailedDescription': 'This study is designed to allow dental hygienists and dentists to provide additional tobacco cessation counseling with little additional marginal effort. This would be done using an Internet-based referral to external resources. This system, termed "ReferASmoker", will allow hygienists and dentists to refer patients to a patient education, self-management website, "Decide2Quit" and accompanying Quitline, while the patient is still in the dental office. We anticipate that hygienists will be the primary drivers of this intervention. Our intervention has several innovations designed to support the dental practice in their tobacco cessation activities and maximize patient cessation rates. We will randomize 80 community-based primary dental practices into a clinical trial.\n\nAim 1. To test hypothesis 1(H1)that the number of patients REFERRED to the self-management resource website will be larger in the intervention practices compared to control practices.\n\nAim 2. To test hypothesis 2 (H2) that the proportion of patients referred who GO to the patient self-management website will be larger in intervention practices compared to control practices\n\nAim 3. To test hypothesis 3 (H3) that the proportion of smokers who are referred who QUIT at six months will be larger among intervention compared to control because of the additional connectivity of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community-based practices with internet access available in the office seeing an average of five or more smokers in a week.\n\nExclusion Criteria:\n\n* Exclude practices that have ongoing computer-based smoking cessation programs for patients.'}, 'identificationModule': {'nctId': 'NCT01108432', 'acronym': 'HiQuit', 'briefTitle': 'DPBRN Hygienists Internet Quality Improvement in Tobacco Cessation (HiQuit)', 'organization': {'class': 'NETWORK', 'fullName': 'Dental Practice-Based Research Network'}, 'officialTitle': 'Hygienists Internet Tobacco Cessation Study (HiQuit)', 'orgStudyIdInfo': {'id': '122286'}, 'secondaryIdInfos': [{'id': 'U01DE016747', 'link': 'https://reporter.nih.gov/quickSearch/U01DE016747', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electronic Referrals', 'description': 'Dental practices randomized to the experimental group will have options on how to refer patients to the tobacco cessation website.', 'interventionNames': ['Other: Electronic Referral']}, {'type': 'NO_INTERVENTION', 'label': 'Routine Referral', 'description': 'Dental practices in this arm will refer patients to the Decide2Quit website by using an information prescription.'}], 'interventions': [{'name': 'Electronic Referral', 'type': 'OTHER', 'description': 'Dental practices in this arm will be able to have option of making electronic patient referrals to the Decide2Quit website.', 'armGroupLabels': ['Electronic Referrals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Health Partners Research Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Gregg H. GIlbert, DDS, MBA', 'role': 'STUDY_CHAIR', 'affiliation': 'Dental Practice-Based Research Network (DPBRN)'}, {'name': 'Midge N. Ray, RN, MSN, CCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama School of Health Professons at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dental Practice-Based Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, {'name': 'HealthPartners Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}