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Completed

NCT Number: NCT01699256

Enhanced Implementation of Low Back Pain Guidelines in General Practice

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Unit for General Practice in the North Denmark Region

Aalborg, 9220, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Guideline implementation as usual

Behavioral

Newsletters and Invitation to Meetings

Enhanced guideline implementation strategy

Behavioral

Enhanced guideline implementation strategy

Primary outcomes

  1. Referral of patients to a secondary care back centre

    Time frame: 12 weeks

Secondary outcomes

  1. Cost-effectiveness

    Time frame: 4, 8, and 52 weeks

  2. Roland Morris 23q disability score

    Time frame: 4, 8, and 52 weeks

  3. Numerical pain rating

    Time frame: 4, 8, and 52 weeks

  4. EQ-5D (Life quality)

    Time frame: 4, 8, and 52 weeks

  5. Sick-leave

    Time frame: 4, 8, and 52 weeks

  6. Employment status

    Time frame: 4, 8, and 52 weeks

Other outcomes

  1. Guideline compliance

    Time frame: During study

  2. Actual delivered intervention

    Time frame: During study

  3. Association between the STart Bact Tool and the functional disability

    Time frame: 8 weeks

    An ancillary analysis of the predictive ability of the STarT Back Tool

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 3, 2012
Registry last updated
Nov 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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