Enhanced Implementation of Low Back Pain Guidelines in General Practice

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Behavioral: Enhanced guideline implementation strategy; Behavioral: Guideline implementation as usual

• Registration Number: NCT01699256
• Lead Sponsor: University of Aarhus

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-09-13
• Study Start: 2012-10
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-03
• Status Verified: 2015-07
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-11-29
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1101

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced strategy	Enhanced guideline implementation strategy	Enhanced implementation strategy
Strategy as usual	Guideline implementation as usual	Normal implementation strategy

Primary Outcome Measures

Name	Time	Method
Referral of patients to a secondary care back centre	12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Unit for General Practice in the North Denmark Region; 🇩🇰 Aalborg, Denmark