NCT01699256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,101

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 30, 2016

Status Verified

July 1, 2015

Enrollment Period

3.6 years

First QC Date

September 13, 2012

Last Update Submit

November 29, 2016

Conditions

Low Back Pain

Keywords

General PracticeLow Back PainGuidelineHealth Plan ImplementationReferral and Consultation

Outcome Measures

Primary Outcomes (1)

  • Referral of patients to a secondary care back centre

    12 weeks

Secondary Outcomes (6)

  • Cost-effectiveness

    4, 8, and 52 weeks

  • Roland Morris 23q disability score

    4, 8, and 52 weeks

  • Numerical pain rating

    4, 8, and 52 weeks

  • EQ-5D (Life quality)

    4, 8, and 52 weeks

  • Sick-leave

    4, 8, and 52 weeks

  • +1 more secondary outcomes

Other Outcomes (3)

  • Guideline compliance

    During study

  • Actual delivered intervention

    During study

  • Association between the STart Bact Tool and the functional disability

    8 weeks

Study Arms (2)

Enhanced strategy

EXPERIMENTAL

Enhanced implementation strategy

Behavioral: Enhanced guideline implementation strategy

Strategy as usual

ACTIVE COMPARATOR

Normal implementation strategy

Behavioral: Guideline implementation as usual

Interventions

Guideline implementation as usualBEHAVIORAL

Newsletters and Invitation to Meetings

Strategy as usual
Enhanced guideline implementation strategyBEHAVIORAL

Enhanced guideline implementation strategy

Enhanced strategy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provider number in the North Denmark Region (Practice level)
  • ICPC coded: L02, L03, L84, and L86 (Patient level)
  • Age 18-65 years (Patient level)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for General Practice in the North Denmark Region

Aalborg, Aalborg, 9220, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 28835238DERIVED

  • 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.

    PMID: 27769263DERIVED

  • 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.

    PMID: 25293975DERIVED

  • 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.

    PMID: 24139140DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Allan Riis, Master

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2012

First Posted

October 3, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 30, 2016

Record last verified: 2015-07

Locations

DK(1)