Enhanced Implementation of Low Back Pain Guidelines in General Practice
NCT ID: NCT01699256
Last Updated: 2016-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1101 participants
INTERVENTIONAL
2012-10-31
2016-05-31
Brief Summary
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Detailed Description
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There 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.
Methods:
This 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).
General 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.
Discussion:
To 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Enhanced strategy
Enhanced implementation strategy
Enhanced guideline implementation strategy
Enhanced guideline implementation strategy
Strategy as usual
Normal implementation strategy
Guideline implementation as usual
Newsletters and Invitation to Meetings
Interventions
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Guideline implementation as usual
Newsletters and Invitation to Meetings
Enhanced guideline implementation strategy
Enhanced guideline implementation strategy
Eligibility Criteria
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Inclusion Criteria
* ICPC coded: L02, L03, L84, and L86 (Patient level)
* Age 18-65 years (Patient level)
Exclusion Criteria
* Earlier participation in project testing (Practice level)
* Already included (Patient level)
* Patients with "red flags"/signs of serious pathology (Patient level)
* Pregnancy (Patient level)
* Insufficient Danish language skills (Patient level)
18 Years
65 Years
ALL
No
Sponsors
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Aalborg University
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Allan Riis, Master
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Research Unit for General Practice in the North Denmark Region
Aalborg, Aalborg, Denmark
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2008-58-0028
Identifier Type: -
Identifier Source: org_study_id