search
Back to results

Enhanced Implementation of Low Back Pain Guidelines in General Practice

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Guideline implementation as usual
Enhanced guideline implementation strategy
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring General Practice, Low Back Pain, Guideline, Health Plan Implementation, Referral and Consultation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Research Unit for General Practice in the North Denmark Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced strategy

Strategy as usual

Arm Description

Enhanced implementation strategy

Normal implementation strategy

Outcomes

Primary Outcome Measures

Referral of patients to a secondary care back centre

Secondary Outcome Measures

Cost-effectiveness
Roland Morris 23q disability score
Numerical pain rating
EQ-5D (Life quality)
Sick-leave
Employment status

Full Information

First Posted
September 13, 2012
Last Updated
November 29, 2016
Sponsor
University of Aarhus
Collaborators
Aalborg University
search

1. Study Identification

Unique Protocol Identification Number
NCT01699256
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aalborg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
General Practice, Low Back Pain, Guideline, Health Plan Implementation, Referral and Consultation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced strategy
Arm Type
Experimental
Arm Description
Enhanced implementation strategy
Arm Title
Strategy as usual
Arm Type
Active Comparator
Arm Description
Normal implementation strategy
Intervention Type
Behavioral
Intervention Name(s)
Guideline implementation as usual
Intervention Description
Newsletters and Invitation to Meetings
Intervention Type
Behavioral
Intervention Name(s)
Enhanced guideline implementation strategy
Intervention Description
Enhanced guideline implementation strategy
Primary Outcome Measure Information:
Title
Referral of patients to a secondary care back centre
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Time Frame
4, 8, and 52 weeks
Title
Roland Morris 23q disability score
Time Frame
4, 8, and 52 weeks
Title
Numerical pain rating
Time Frame
4, 8, and 52 weeks
Title
EQ-5D (Life quality)
Time Frame
4, 8, and 52 weeks
Title
Sick-leave
Time Frame
4, 8, and 52 weeks
Title
Employment status
Time Frame
4, 8, and 52 weeks
Other Pre-specified Outcome Measures:
Title
Guideline compliance
Time Frame
During study
Title
Actual delivered intervention
Time Frame
During study
Title
Association between the STart Bact Tool and the functional disability
Description
An ancillary analysis of the predictive ability of the STarT Back Tool
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Riis, Master
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Unit for General Practice in the North Denmark Region
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28835238
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.
Results Reference
derived
PubMed Identifier
27769263
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.
Results Reference
derived
PubMed Identifier
25293975
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.
Results Reference
derived
PubMed Identifier
24139140
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.
Results Reference
derived

Learn more about this trial

Enhanced Implementation of Low Back Pain Guidelines in General Practice

We'll reach out to this number within 24 hrs