<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01699256</url>
  </required_header>
  <id_info>
    <org_study_id>2008-58-0028</org_study_id>
    <nct_id>NCT01699256</nct_id>
  </id_info>
  <brief_title>Enhanced Implementation of Low Back Pain Guidelines in General Practice</brief_title>
  <official_title>Enhanced Implementation of Low Back Pain Guidelines in General Practice: A Cluster Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate whether an enhanced strategy of implementation of the&#xD;
      new guideline will lower the number of patients getting referred to secondary care spine&#xD;
      centres compared to a normal implementation strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      There is a need for more knowledge on how to introduce new guidelines effectively in general&#xD;
      practice. A new low back pain treatment guideline is implemented in Denmark. This guideline&#xD;
      demands that patients with low back pain who have not improved after eight weeks of primary&#xD;
      care treatment should be referred to a secondary care spine centre.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      This is a cluster randomized trial. One hundred general practices define clusters and are&#xD;
      randomly allocated to enhanced or usual implementation of the new guideline. The practices&#xD;
      are all situated in the North Denmark Region and count two hundred general practitioners&#xD;
      (GPs).&#xD;
&#xD;
      General practices in the control group will receive normal implementation of the new&#xD;
      guideline, which include newsletters and briefings. In contrast the intervention group will&#xD;
      receive an enhanced implementation strategy, adding visits from a consultant, two different&#xD;
      stratification tools and feedback on guideline compliance. The two stratification tools: The&#xD;
      STarT back screening tool (STarT) and a &quot;Social and Occupational Screening&quot; tool (SOS). The&#xD;
      two screening tools subgroups patients and aids the clinicians in their choice of treatment.&#xD;
&#xD;
      Discussion:&#xD;
&#xD;
      To evaluate how change in behaviour may improve guideline adherence and patient treatment we&#xD;
      plan two Ph.d. studies in relation to this study; one focusing on the clinical and an one on&#xD;
      the economic aspects of the study. In addition a qualitative study is planned for patients&#xD;
      refered to specialists in social medicine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Referral of patients to a secondary care back centre</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>4, 8, and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Roland Morris 23q disability score</measure>
    <time_frame>4, 8, and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical pain rating</measure>
    <time_frame>4, 8, and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D (Life quality)</measure>
    <time_frame>4, 8, and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sick-leave</measure>
    <time_frame>4, 8, and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Employment status</measure>
    <time_frame>4, 8, and 52 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Guideline compliance</measure>
    <time_frame>During study</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Actual delivered intervention</measure>
    <time_frame>During study</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Association between the STart Bact Tool and the functional disability</measure>
    <time_frame>8 weeks</time_frame>
    <description>An ancillary analysis of the predictive ability of the STarT Back Tool</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1101</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Enhanced strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enhanced implementation strategy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Strategy as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Normal implementation strategy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Guideline implementation as usual</intervention_name>
    <description>Newsletters and Invitation to Meetings</description>
    <arm_group_label>Strategy as usual</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced guideline implementation strategy</intervention_name>
    <description>Enhanced guideline implementation strategy</description>
    <arm_group_label>Enhanced strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provider number in the North Denmark Region (Practice level)&#xD;
&#xD;
          -  ICPC coded: L02, L03, L84, and L86 (Patient level)&#xD;
&#xD;
          -  Age 18-65 years (Patient level)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No signed written consent form (Practice level)&#xD;
&#xD;
          -  Earlier participation in project testing (Practice level)&#xD;
&#xD;
          -  Already included (Patient level)&#xD;
&#xD;
          -  Patients with &quot;red flags&quot;/signs of serious pathology (Patient level)&#xD;
&#xD;
          -  Pregnancy (Patient level)&#xD;
&#xD;
          -  Insufficient Danish language skills (Patient level)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allan Riis, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aarhus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Unit for General Practice in the North Denmark Region</name>
      <address>
        <city>Aalborg</city>
        <zip>9220</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>General Practice</keyword>
  <keyword>Low Back Pain</keyword>
  <keyword>Guideline</keyword>
  <keyword>Health Plan Implementation</keyword>
  <keyword>Referral and Consultation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01699256
org study id: 2008-58-0028
nct id: NCT01699256
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Referral of patients to a secondary care back centre
time frame: 12 weeks
measure: Cost-effectiveness
time frame: 4, 8, and 52 weeks
measure: Roland Morris 23q disability score
time frame: 4, 8, and 52 weeks
measure: Numerical pain rating
time frame: 4, 8, and 52 weeks
measure: EQ-5D (Life quality)
time frame: 4, 8, and 52 weeks
measure: Sick-leave
time frame: 4, 8, and 52 weeks
measure: Employment status
time frame: 4, 8, and 52 weeks
measure: Guideline compliance
time frame: During study
measure: Actual delivered intervention
time frame: During study
measure: Association between the STart Bact Tool and the functional disability
time frame: 8 weeks
description: An ancillary analysis of the predictive ability of the STarT Back Tool
arm group label: Enhanced strategy
arm group type: Experimental
description: Enhanced implementation strategy
arm group label: Strategy as usual
arm group type: Active Comparator
description: Normal implementation strategy
intervention type: Behavioral
intervention name: Guideline implementation as usual
description: Newsletters and Invitation to Meetings
arm group label: Strategy as usual
intervention type: Behavioral
intervention name: Enhanced guideline implementation strategy
description: Enhanced guideline implementation strategy
arm group label: Enhanced strategy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Allan Riis, Master
role: Principal Investigator
affiliation: University of Aarhus
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain