Enhanced Implementation of Low Back Pain Guidelines in General Practice

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Enhanced guideline implementation strategy; Behavioral: Guideline implementation as usual

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.

• Study Type: Interventional
• Enrollment (Actual): 1101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9220
    • Research Unit for General Practice in the North Denmark Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced strategy; Enhanced implementation strategy	Behavioral: Enhanced guideline implementation strategy; Enhanced guideline implementation strategy
Active Comparator: Strategy as usual; Normal implementation strategy	Behavioral: Guideline implementation as usual; Newsletters and Invitation to Meetings

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Guideline compliance		During study
Actual delivered intervention		During study
Association between the STart Bact Tool and the functional disability	An ancillary analysis of the predictive ability of the STarT Back Tool	8 weeks

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aalborg University
• Investigators: Principal Investigator: Allan Riis, Master, University of Aarhus

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 13, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Estimate): November 30, 2016
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Low Back Pain; General Practice; Guideline; Health Plan Implementation; Referral and Consultation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2008-58-0028