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Enhanced Implementation of Low Back Pain Guidelines in General Practice

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Aarhus
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01699256
First received: September 13, 2012
Last updated: December 18, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Referral of patients to a secondary care back centre [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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: February 2016
Estimated Primary Completion Date: October 2014 (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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699256

Contacts
Contact: Allan Riis, Master +45 20823660 a.riis@rn.dk
Contact: Martin B Jensen, Ph.d. +45 25154519 mbj@rn.dk

Locations
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         
Sponsors and Collaborators
University of Aarhus
Aalborg University
Investigators
Principal Investigator: Allan Riis, Master University of Aarhus
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: December 18, 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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014