Enhanced Implementation of Low Back Pain Guidelines in Ge... | NCT01699256

Studies
Enhanced Implementation of Low Back Pain Guidelines in General Practice

NCT01699256

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Nov 30, 2016Estimated

Enrollment

1,101Actual

Phase

Not Applicable

Conditions

Low Back Pain

Interventions

Guideline implementation as usual
Enhanced guideline implementation strategy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Sep 13, 2012

First Submission Date that Met QC Criteria

Oct 2, 2012

First Posted Date

Oct 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2016

Last Update Posted Date

Nov 30, 2016Estimated

Name	Class
Aalborg University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Guideline implementation as usual	Behavioral	Newsletters and Invitation to Meetings	Strategy as usual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Referral of patients to a secondary care back centre		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Cost-effectiveness		4, 8, and 52 weeks
Roland Morris 23q disability score		4, 8, and 52 weeks
Numerical pain rating

Other Outcomes

Measure	Description	Time Frame
Guideline compliance		During study
Actual delivered intervention		During study
Association between the STart Bact Tool and the functional disability

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allan Riis, Master	University of Aarhus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Unit for General Practice in the North Denmark Region		Aalborg	Aalborg	9220	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28835238	Derived	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.
27769263	Derived	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.

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms