Enhanced Implementation of Low Back Pain Guidelines in General Practice

Study Overview
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Brief Summary
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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.

Detailed Description
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Introduction: 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.

Official Title
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Enhanced Implementation of Low Back Pain Guidelines in General Practice: A Cluster Randomized Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Guideline implementation as usual
* Behavioral: Enhanced guideline implementation strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provider number in the North Denmark Region (Practice level) ICPC coded: L02, L03, L84, and L86 (Patient level) Age 18-65 years (Patient level) Exclusion Criteria: No signed written consent form (Practice level) 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced strategy<br>Enhanced implementation strategy | Behavioral: Enhanced guideline implementation strategy<br>* Enhanced guideline implementation strategy<br>|
| Active Comparator: Strategy as usual<br>Normal implementation strategy | Behavioral: Guideline implementation as usual<br>* Newsletters and Invitation to Meetings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Referral of patients to a secondary care back centre |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness |  | 4, 8, and 52 weeks | 
| Roland Morris 23q disability score |  | 4, 8, and 52 weeks | 
| Numerical pain rating |  | 4, 8, and 52 weeks | 
| EQ-5D (Life quality) |  | 4, 8, and 52 weeks | 
| Sick-leave |  | 4, 8, and 52 weeks | 
| Employment status |  | 4, 8, and 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General Practice, Low Back Pain, Guideline, Health Plan Implementation, Referral and Consultation