Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000098538
Ethics application status
Approved
Date submitted
11/03/2006
Date registered
14/03/2006
Date last updated
13/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The management of acute low-back pain in general practice
Scientific title
Implementing a clinical practice guideline for acute low-back pain evidence-based management in general practice: a cluster randomised controlled trial of the effectiveness of a tailored implementation strategy on patient low-back pain disability and x-ray referral
Secondary ID [1] 281227 0
Nil
Universal Trial Number (UTN)
Trial acronym
IMPLEMENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute (duration <3 months) non-specific low-back pain 1062 0
Condition category
Condition code
Musculoskeletal 1142 1142 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: tailored implementation strategy (face-to-face education sessions, printed educational materials and patient education) for a clinical practice guideline. Delivered over a two month time period.
Intervention code [1] 938 0
None
Intervention code [2] 285693 0
Other interventions
Comparator / control treatment
Control: dissemination only of the clinical practice guideline. Delivered at a single time point.
Control group
Active

Outcomes
Primary outcome [1] 1535 0
General practitioner (GP) level #1: measurement of behavioural constructs measured by a questionnaire developed by our research team for this trial. Questionnaire items were designed by considering constructs relevant to behaviour (drawn from the Theoretical Domains Framework and the Theory of Planned Behaviour)
Michie S, Johnston M, Abraham C, Lawton R, Parker D, et al. (2005) Making psychological theory useful for implementing evidence based practice: a consensus approach. Quality & Safety in Health Care 14: 26-33.
Ajzen I (1991) The theory of planned behavior. Organizational Behavior and Human Decision Processes 50: 179-211
Francis J, Eccles M, Johnston M, Walker A, Grimshaw J, et al. Constructing questionnaires based on the theory of planned behaviour. A manual for health services researchers, 2004. Centre for Health Services Research, University of Newcastle
Timepoint [1] 1535 0
Baseline and 12 months after intervention/control delivery
Primary outcome [2] 1536 0
GP level #2: Behavioural simulation outcomes (clinical decision in response to vignettes)
Timepoint [2] 1536 0
12 months after intervention/control delivery
Primary outcome [3] 287987 0
GP level #3: Referral rates for plain x-ray and CT scan (Administrative data outcomes)
Timepoint [3] 287987 0
12 months after intervention/control delivery
Secondary outcome [1] 2772 0
GP level #4: GPs' fear avoidance beliefs about low back pain were measured via a modified version of the Fear-Avoidance Beliefs Questionnaire (FAB-Q) physical activity subscale adapted for the GP participants.
Waddell G, Newton M, Henderson I, Somerville D, Main CJ (1993) A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain 52: 157-168.
Coudeyre E, Rannou F, Tubach F, Baron G, Coriat F, et al. (2006) General practitioners' fear-avoidance beliefs influence their management of patients with low back pain. Pain 124: 330-337
Timepoint [1] 2772 0
baseline and 12 months

Eligibility
Key inclusion criteria
General practices will be included if:1. The practice manager agrees to the practice being involved in the C-RCT.2. At least one GP, and no objection from the remaining GPs, within the practice provide written informed consent.3. Practice GPs do not work in more than one practice.4. Practice support staff are willing to facilitate patient recruitment. Patients will be included if:1. They attend the participating practices for acute non-specific LBP (duration of less than three months).2. Provide written informed consent.3. Are able to write and understand English.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General practices will be excluded if:1. Any of the GPs at the practice participated in focus groups during part one of this study.Patients will be excluded if:1. Radicular pain is present.2. They have had previous spinal surgery.3. “Red flags” are present, alerting the possibility of serious conditions such as malignancy, infection and fracture.4. Pregnancy.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A statistician independent of the study and located at a central administration location will implement the randomisation. Allocation will involve contacting the statistician via phone/email and providing them only with general practice codes and strata variables which will be used in the randomisation. The statistician will then provide the allocation of the general practices.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Restricted randomisation will be employed. Computer generated random numbers will be used to randomly select permutations.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1247 0
Government body
Name [1] 1247 0
NHMRC,Primary Health Care Project Grant 334060
Country [1] 1247 0
Australia
Primary sponsor type
University
Name
Institute of Health Services Research, Monash University
Address
43-51 Kanooka Grove
Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 1102 0
University
Name [1] 1102 0
Department of General Practice, Monash University
Address [1] 1102 0
Building 1, Omnico Business Park
270 Ferntree Gully Rd
Notting Hill VIC 3168
Country [1] 1102 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2581 0
Monash University Standing Committee on Ethics in Research Involving Humans
Ethics committee address [1] 2581 0
Ethics committee country [1] 2581 0
Australia
Date submitted for ethics approval [1] 2581 0
Approval date [1] 2581 0
Ethics approval number [1] 2581 0
2006/047

Summary
Brief summary
The recently released NHMRC-endorsed evidence-based clinical practice guideline for acute low-back pain management provides an opportunity to assess the effects of a tailored implementation strategy for use in general medical practice. This trial will assess the effectiveness of the implementation strategy both at the general practitioner and patient level and also assess the cost effectiveness of the strategy. Successful implementation of these guidelines will reduce the morbidity and cost of acute low-back pain. The trial will contribute to our knowledge about implementation strategies attempting to change clinical practice behaviour.
Trial website
http://www.cochrane.org.au/projects/implement.php
Trial related presentations / publications
McKenzie J, French S, O'Connor D, Grimshaw J, Mortimer D, Michie S, Francis F, Spike N, Schattner P, Kent P, Buchbinder R & Green S (2008). IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT): cluster randomised controlled trial study protocol. Implementation Science 3: 11

Mortimer D, French S, McKenzie J, O'Connor D & Green S (2008). Protocol for economic evaluation alongside the IMPLEMENT cluster randomised controlled trial. Implementation Science 3: 12

Page MJ, French SD, McKenzie JE, O'Connor DA, Green SE (2011) Recruitment difficulties in a primary care cluster randomised trial: investigating factors contributing to general practitioners' recruitment of patients. BMC Med Res Methodol 11: 35

French SD, Green SE, O'Connor DA, McKenzie JE, Francis JJ, et al. (2012) Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework. Implement Sci 7: 38
Public notes

Contacts
Principal investigator
Name 35347 0
Address 35347 0
Country 35347 0
Phone 35347 0
Fax 35347 0
Email 35347 0
Contact person for public queries
Name 10127 0
Simon French
Address 10127 0
Centre for Health, Exercise and Sports Medicine
The University of Melbourne
200 Berkeley St
Carlton, Victoria 3010
Country 10127 0
Australia
Phone 10127 0
+61 3 83445536
Fax 10127 0
Email 10127 0
s.french@unimelb.edu.au
Contact person for scientific queries
Name 1055 0
Sally Green
Address 1055 0
School of Public Health and Preventive Medicine
Level 6, The Alfred Centre
99 Commercial Road Melbourne VIC 3004
Country 1055 0
Australia
Phone 1055 0
+61 3 99030366
Fax 1055 0
Email 1055 0
sally.green@monash.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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