Clinical trial NCT01699256: Enhanced Implementation of Low Back Pain Guidelines in General Practice
Official title: Enhanced Implementation of Low Back Pain Guidelines in General Practice: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: General Practice
Low Back Pain
Guideline
Health Plan Implementation
Referral and Consultation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2012-10-03
Enrollment: 1101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Referral of patients to a secondary care back centre
timeFrame: 12 weeks
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 4, 8, and 52 weeks
measure: Roland Morris 23q disability score
timeFrame: 4, 8, and 52 weeks
measure: Numerical pain rating
timeFrame: 4, 8, and 52 weeks
measure: EQ-5D (Life quality)
timeFrame: 4, 8, and 52 weeks
measure: Sick-leave
timeFrame: 4, 8, and 52 weeks
measure: Employment status
timeFrame: 4, 8, and 52 weeks
Other outcomes:
measure: Guideline compliance
timeFrame: During study
measure: Actual delivered intervention
timeFrame: During study
measure: Association between the STart Bact Tool and the functional disability
timeFrame: 8 weeks
Locations:
city: Aalborg
country: Denmark
facility: Research Unit for General Practice in the North Denmark Region
Study officials:
affiliation: University of Aarhus
name: Allan Riis, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.