Low Back PainNCT01699256
Enhanced Implementation of Low Back Pain Guidelines in General Practice
A study testing Guideline implementation as usual and Enhanced guideline implementation strategy in people with Low Back Pain, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Guideline implementation as usual and Enhanced guideline implementation strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,101 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provider number in the North Denmark Region (Practice level)
- ICPC coded: L02, L03, L84, and L86 (Patient level)
- Age 18-65 years (Patient level)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit for General Practice in the North Denmark Region
Aalborg, Aalborg, 9220
About this study
Official title: Enhanced Implementation of Low Back Pain Guidelines in General Practice: A Cluster Randomized Trial
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Guideline implementation as usual, Enhanced guideline implementation strategy
- Keywords
- General Practice, Low Back Pain, Guideline, Health Plan Implementation, Referral and Consultation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline implementation as usualBehavioural
Newsletters and Invitation to Meetings
Enhanced guideline implementation strategyBehavioural
Enhanced guideline implementation strategy
| Study group | Role | What they receive |
|---|---|---|
| Enhanced strategy | Experimental | Enhanced implementation strategy Receives: Behavioral: Enhanced guideline implementation strategy |
| Strategy as usual | Active comparator | Normal implementation strategy Receives: Behavioral: Guideline implementation as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral of patients to a secondary care back centre
Measured: 12 weeks
Secondary outcomes (6)
Cost-effectiveness
Measured: 4, 8, and 52 weeks
Roland Morris 23q disability score
Measured: 4, 8, and 52 weeks
Numerical pain rating
Measured: 4, 8, and 52 weeks
EQ-5D (Life quality)
Measured: 4, 8, and 52 weeks
Sick-leave
Measured: 4, 8, and 52 weeks
Employment status
Measured: 4, 8, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor
- Investigators
- Allan Riis, Master, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699256
- Sponsor's protocol ID
- 2008-58-0028
- Status last verified
- Jul 2015
- First submitted
- 13 Sep 2012
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28835238Riis 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.
PubMed 27769263Jensen 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.
PubMed 25293975Riis 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.
PubMed 24139140
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Implementation of Low Back Pain Guidelines in General Practice: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01699256
- Acronym / sponsor ID
- 2008-58-0028
- Conditions
- Low Back Pain
- Keywords
- General Practice, Low Back Pain, Guideline, Health Plan Implementation, Referral and Consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,101 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- Oct 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced strategy | Experimental | Behavioral: Enhanced guideline implementation strategyEnhanced implementation strategy |
| Strategy as usual | Active comparator | Behavioral: Guideline implementation as usualNormal implementation strategy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provider number in the North Denmark Region (Practice level)
- ICPC coded: L02, L03, L84, and L86 (Patient level)
- Age 18-65 years (Patient level)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guideline implementation as usualNewsletters and Invitation to Meetings | Behavioural | Strategy as usual |
| Enhanced guideline implementation strategyEnhanced guideline implementation strategy | Behavioural | Enhanced strategy |
Primary outcome
Referral of patients to a secondary care back centre
Time frame: 12 weeks
6 secondary outcomes
Cost-effectiveness
Time frame: 4, 8, and 52 weeks
Roland Morris 23q disability score
Time frame: 4, 8, and 52 weeks
Numerical pain rating
Time frame: 4, 8, and 52 weeks
EQ-5D (Life quality)
Time frame: 4, 8, and 52 weeks
Sick-leave
Time frame: 4, 8, and 52 weeks
Employment status
Time frame: 4, 8, and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Derived from this study: PubMed 28835238Riis 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.
- Derived from this study: PubMed 27769263Riis 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.
- Derived from this study: PubMed 25293975Jensen 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.
- Derived from this study: PubMed 24139140Riis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Riis, Master principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guideline implementation as usual and Enhanced guideline implementation strategy in people with Low Back Pain, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referral of patients to a secondary care back centre (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01699256, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.