Enhanced Implementation of Low Back Pain Guidelines in General Practice

University of Aarhus

Status: Completed

Conditions: Low Back Pain

Treatments: Behavioral: Enhanced guideline implementation strategy; Behavioral: Guideline implementation as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT01699256

2008-58-0028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,101 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,101 participants in 2 patient groups

Enhanced strategy

Experimental group

Description:

Enhanced implementation strategy

Treatment:

Behavioral: Enhanced guideline implementation strategy

Strategy as usual

Active Comparator group

Description:

Normal implementation strategy

Treatment:

Behavioral: Guideline implementation as usual