Enhanced Implementation of Low Back Pain Guidelines in General Practice
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Low Back Pain |
Behavioral: Guideline implementation as usual Behavioral: Enhanced guideline implementation strategy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Enhanced Implementation of Low Back Pain Guidelines in General Practice: A Cluster Randomized Trial |
- Referral of patients to a secondary care back centre [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Cost-effectiveness [ Time Frame: 4, 8, and 52 weeks ] [ Designated as safety issue: No ]
- Roland Morris 23q disability score [ Time Frame: 4, 8, and 52 weeks ] [ Designated as safety issue: No ]
- Numerical pain rating [ Time Frame: 4, 8, and 52 weeks ] [ Designated as safety issue: No ]
- EQ-5D (Life quality) [ Time Frame: 4, 8, and 52 weeks ] [ Designated as safety issue: No ]
- Sick-leave [ Time Frame: 4, 8, and 52 weeks ] [ Designated as safety issue: No ]
- Employment status [ Time Frame: 4, 8, and 52 weeks ] [ Designated as safety issue: No ]
- Guideline compliance [ Time Frame: During study ] [ Designated as safety issue: No ]
- Actual delivered intervention [ Time Frame: During study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2700 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Enhanced strategy
Enhanced implementation strategy
|
Behavioral: Enhanced guideline implementation strategy
Enhanced guideline implementation strategy
|
|
Active Comparator: Strategy as asual
Normal implementation strategy
|
Behavioral: Guideline implementation as usual
Newsletters and Invitation to Meetings
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Allan Riis, Master | +45 20823660 | a.riis@rn.dk |
| Contact: Martin B Jensen, Ph.d. | +45 25154519 | mbj@rn.dk |
| Denmark | |
| Research Unit for General Practice in the North Denmark Region | Recruiting |
| Aalborg, Denmark, 9220 | |
| Contact: Allan Riis, Master +45 20823660 a.riis@rn.dk | |
| Contact: Martin B Jensen, Ph.d. +45 25154519 mbj@rn.dk | |
| Principal Investigator: Allan Riis, Master | |
| Principal Investigator: Cathrine E Jensen, Master | |
| Principal Investigator: | Allan Riis, Master | University of Aarhus |
More Information
No publications provided
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01699256 History of Changes |
| Other Study ID Numbers: | 2008-58-0028 |
| Study First Received: | September 13, 2012 |
| Last Updated: | April 12, 2013 |
| Health Authority: | Denmark: Danish Health and Medicines Authority |
Keywords provided by University of Aarhus:
|
General Practice Low Back Pain Guideline Health Plan Implementation Referral and Consultation |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013