Enhanced Implementation of Low Back Pain Guidelines in General Practice

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699256
• Other study ID #: 2008-58-0028
• Status: Completed
• Phase: N/A
• First received: September 13, 2012
• Last updated: November 29, 2016
• Start date: October 2012
• Est. completion date: May 2016

Study information

• Verified date: July 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1101
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Guideline implementation as usual
Newsletters and Invitation to Meetings
• Enhanced guideline implementation strategy
Enhanced guideline implementation strategy

Locations

Country	Name	City	State
Denmark	Research Unit for General Practice in the North Denmark Region	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Guideline compliance		During study	No
Other	Actual delivered intervention		During study	No
Other	Association between the STart Bact Tool and the functional disability	An ancillary analysis of the predictive ability of the STarT Back Tool	8 weeks	No
Primary	Referral of patients to a secondary care back centre		12 weeks	No
Secondary	Cost-effectiveness		4, 8, and 52 weeks	No
Secondary	Roland Morris 23q disability score		4, 8, and 52 weeks	No
Secondary	Numerical pain rating		4, 8, and 52 weeks	No
Secondary	EQ-5D (Life quality)		4, 8, and 52 weeks	No
Secondary	Sick-leave		4, 8, and 52 weeks	No
Secondary	Employment status		4, 8, and 52 weeks	No