Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-30 @ 2:46 PM
Study NCT ID:
NCT01699256
Status:
COMPLETED
Last Update Posted:
2016-11-30
First Post:
2012-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Implementation of Low Back Pain Guidelines in General Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2012-09-13', 'studyFirstSubmitQcDate': '2012-10-02', 'lastUpdatePostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Guideline compliance', 'timeFrame': 'During study'}, {'measure': 'Actual delivered intervention', 'timeFrame': 'During study'}, {'measure': 'Association between the STart Bact Tool and the functional disability', 'timeFrame': '8 weeks', 'description': 'An ancillary analysis of the predictive ability of the STarT Back Tool'}], 'primaryOutcomes': [{'measure': 'Referral of patients to a secondary care back centre', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness', 'timeFrame': '4, 8, and 52 weeks'}, {'measure': 'Roland Morris 23q disability score', 'timeFrame': '4, 8, and 52 weeks'}, {'measure': 'Numerical pain rating', 'timeFrame': '4, 8, and 52 weeks'}, {'measure': 'EQ-5D (Life quality)', 'timeFrame': '4, 8, and 52 weeks'}, {'measure': 'Sick-leave', 'timeFrame': '4, 8, and 52 weeks'}, {'measure': 'Employment status', 'timeFrame': '4, 8, and 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['General Practice', 'Low Back Pain', 'Guideline', 'Health Plan Implementation', 'Referral and Consultation'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '28835238', 'type': 'DERIVED', 'citation': 'Riis A, Rathleff MS, Jensen CE, Jensen MB. Predictive ability of the start back tool: an ancillary analysis of a low back pain trial from Danish general practice. BMC Musculoskelet Disord. 2017 Aug 23;18(1):360. doi: 10.1186/s12891-017-1727-6.'}, {'pmid': '27769263', 'type': 'DERIVED', 'citation': 'Riis A, Jensen CE, Bro F, Maindal HT, Petersen KD, Bendtsen MD, Jensen MB. A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice: a cluster randomised controlled trial. Implement Sci. 2016 Oct 21;11(1):143. doi: 10.1186/s13012-016-0509-0.'}, {'pmid': '25293975', 'type': 'DERIVED', 'citation': 'Jensen CE, Riis A, Pedersen KM, Jensen MB, Petersen KD. Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial. Implement Sci. 2014 Oct 8;9:140. doi: 10.1186/s13012-014-0140-x.'}, {'pmid': '24139140', 'type': 'DERIVED', 'citation': 'Riis A, Jensen CE, Bro F, Maindal HT, Petersen KD, Jensen MB. Enhanced implementation of low back pain guidelines in general practice: study protocol of a cluster randomised controlled trial. Implement Sci. 2013 Oct 20;8:124. doi: 10.1186/1748-5908-8-124.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate whether an enhanced strategy of implementation of the new guideline will lower the number of patients getting referred to secondary care spine centres compared to a normal implementation strategy.', 'detailedDescription': 'Introduction:\n\nThere is a need for more knowledge on how to introduce new guidelines effectively in general practice. A new low back pain treatment guideline is implemented in Denmark. This guideline demands that patients with low back pain who have not improved after eight weeks of primary care treatment should be referred to a secondary care spine centre.\n\nMethods:\n\nThis is a cluster randomized trial. One hundred general practices define clusters and are randomly allocated to enhanced or usual implementation of the new guideline. The practices are all situated in the North Denmark Region and count two hundred general practitioners (GPs).\n\nGeneral practices in the control group will receive normal implementation of the new guideline, which include newsletters and briefings. In contrast the intervention group will receive an enhanced implementation strategy, adding visits from a consultant, two different stratification tools and feedback on guideline compliance. The two stratification tools: The STarT back screening tool (STarT) and a "Social and Occupational Screening" tool (SOS). The two screening tools subgroups patients and aids the clinicians in their choice of treatment.\n\nDiscussion:\n\nTo evaluate how change in behaviour may improve guideline adherence and patient treatment we plan two Ph.d. studies in relation to this study; one focusing on the clinical and an one on the economic aspects of the study. In addition a qualitative study is planned for patients refered to specialists in social medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provider number in the North Denmark Region (Practice level)\n* ICPC coded: L02, L03, L84, and L86 (Patient level)\n* Age 18-65 years (Patient level)\n\nExclusion Criteria:\n\n* No signed written consent form (Practice level)\n* Earlier participation in project testing (Practice level)\n* Already included (Patient level)\n* Patients with "red flags"/signs of serious pathology (Patient level)\n* Pregnancy (Patient level)\n* Insufficient Danish language skills (Patient level)'}, 'identificationModule': {'nctId': 'NCT01699256', 'briefTitle': 'Enhanced Implementation of Low Back Pain Guidelines in General Practice', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Enhanced Implementation of Low Back Pain Guidelines in General Practice: A Cluster Randomized Trial', 'orgStudyIdInfo': {'id': '2008-58-0028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced strategy', 'description': 'Enhanced implementation strategy', 'interventionNames': ['Behavioral: Enhanced guideline implementation strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Strategy as usual', 'description': 'Normal implementation strategy', 'interventionNames': ['Behavioral: Guideline implementation as usual']}], 'interventions': [{'name': 'Guideline implementation as usual', 'type': 'BEHAVIORAL', 'description': 'Newsletters and Invitation to Meetings', 'armGroupLabels': ['Strategy as usual']}, {'name': 'Enhanced guideline implementation strategy', 'type': 'BEHAVIORAL', 'description': 'Enhanced guideline implementation strategy', 'armGroupLabels': ['Enhanced strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9220', 'city': 'Aalborg', 'state': 'Aalborg', 'country': 'Denmark', 'facility': 'Research Unit for General Practice in the North Denmark Region', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Allan Riis, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}