Skip to main content
Top
Published in: Implementation Science 1/2015

Open Access 01-12-2016 | Research

A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice: a cluster randomised controlled trial

Authors: Allan Riis, Cathrine Elgaard Jensen, Flemming Bro, Helle Terkildsen Maindal, Karin Dam Petersen, Mette Dahl Bendtsen, Martin Bach Jensen

Published in: Implementation Science | Issue 1/2015

Login to get access

Abstract

Background

Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP) guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS).

Methods

In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate. Practices were randomised (1:1) and stratified by practice size to MuIS (28 practices) or a passive implementation strategy (PaIS; 32 practices). Included were patients with LBP aged 18 to 65 years who were able to complete questionnaires, had no serious underlying pathology, and were not pregnant. We developed a MuIS including outreach visits, quality reports, and the STarT Back Tool for subgrouping patients with LBP. Both groups were offered the usual dissemination of guidelines, guideline-concordant structuring of the medical record, and a new referral opportunity for patients with psycho-social problems. In an intention-to-treat analysis, the primary and secondary outcomes pertained to the patient, and a cost-effectiveness analysis was performed from a healthcare sector perspective. Patients and the assessment of outcomes were blinded. Practices and caregivers delivering the interventions were not blinded.

Results

Between January 2013 and July 2014, 60 practices were included, of which 54 practices (28 MuIS, 26 PaIS) included 1101 patients (539 MuIS, 562 PaIS). Follow-up data for the primary outcome were available on 100 % of these patients. Twenty-seven patients (5.0 %) in the MuIS group were referred to secondary care vs. 59 patients (10.5 %) in the PaIS group. The adjusted odds ratio (AOR) was 0.52 [95 % CI 0.30 to 0.90; p = 0.020]. The MuIS was cost-saving £−93.20 (£406.51 vs. £499.71 per patient) after 12 weeks. Conversely, the MuIS resulted in less satisfied patients after 52 weeks (AOR 0.50 [95 % CI 0.31 to 0.81; p = 0.004]).

Conclusions

Using a MuIS changed general practice referral behaviour and was cost effective, but patients in the MuIS group were less satisfied. This study supports the application of a MuIS when implementing guidelines.

Trial registration

ClinicalTrials.gov, NCT01699256
Appendix
Available only for authorised users
Literature
1.
go back to reference Newton JN, Briggs AD, Murray CJ, Dicker D, Foreman KJ, Wang H, et al. Changes in health in England, with analysis by English regions and areas of deprivation, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386(10010):2257–74.CrossRefPubMedPubMedCentral Newton JN, Briggs AD, Murray CJ, Dicker D, Foreman KJ, Wang H, et al. Changes in health in England, with analysis by English regions and areas of deprivation, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386(10010):2257–74.CrossRefPubMedPubMedCentral
2.
go back to reference Hancock MJ, Maher CG, Laslett M, Hay E, Koes B. Discussion paper: what happened to the ‘bio’ in the bio-psycho-social model of low back pain? Eur Spine J. 2011;20(12):2105–10.CrossRefPubMedPubMedCentral Hancock MJ, Maher CG, Laslett M, Hay E, Koes B. Discussion paper: what happened to the ‘bio’ in the bio-psycho-social model of low back pain? Eur Spine J. 2011;20(12):2105–10.CrossRefPubMedPubMedCentral
3.
go back to reference Nicholas MK, Linton SJ, Watson PJ, Decade of the Flags Working Group, Main CJ. Early identification and management of psychological risk factors (“yellow flags”) in patients with low back pain: a reappraisal. Phys Ther. 2011;91(5):737–53.CrossRefPubMed Nicholas MK, Linton SJ, Watson PJ, Decade of the Flags Working Group, Main CJ. Early identification and management of psychological risk factors (“yellow flags”) in patients with low back pain: a reappraisal. Phys Ther. 2011;91(5):737–53.CrossRefPubMed
4.
go back to reference Cook CE, Taylor J, Wright A, Milosavljevic S, Goode A, Whitford M. Risk factors for first time incidence sciatica: a systematic review. Physiother Res Int. 2014;19(2):65–78.CrossRefPubMed Cook CE, Taylor J, Wright A, Milosavljevic S, Goode A, Whitford M. Risk factors for first time incidence sciatica: a systematic review. Physiother Res Int. 2014;19(2):65–78.CrossRefPubMed
5.
go back to reference Gagliardi AR, Marshall C, Huckson S, James R, Moore V. Developing a checklist for guideline implementation planning: review and synthesis of guideline development and implementation advice. Implement Sci. 2015;10(1):19. -015-0205-5.CrossRefPubMedPubMedCentral Gagliardi AR, Marshall C, Huckson S, James R, Moore V. Developing a checklist for guideline implementation planning: review and synthesis of guideline development and implementation advice. Implement Sci. 2015;10(1):19. -015-0205-5.CrossRefPubMedPubMedCentral
7.
go back to reference Prior M, Guerin M, Grimmer-Somers K. The effectiveness of clinical guideline implementation strategies--a synthesis of systematic review findings. J Eval Clin Pract. 2008;14(5):888–97.CrossRefPubMed Prior M, Guerin M, Grimmer-Somers K. The effectiveness of clinical guideline implementation strategies--a synthesis of systematic review findings. J Eval Clin Pract. 2008;14(5):888–97.CrossRefPubMed
8.
go back to reference Gagliardi AR, Brouwers MC. Do guidelines offer implementation advice to target users? A systematic review of guideline applicability. BMJ Open. 2015;5(2), e007047. -2014-007047.CrossRefPubMedPubMedCentral Gagliardi AR, Brouwers MC. Do guidelines offer implementation advice to target users? A systematic review of guideline applicability. BMJ Open. 2015;5(2), e007047. -2014-007047.CrossRefPubMedPubMedCentral
9.
go back to reference 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;8:124-5908-8-124.CrossRef 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;8:124-5908-8-124.CrossRef
10.
go back to reference Pedersen KM, Andersen JS, Sondergaard J. General practice and primary health care in Denmark. J Am Board Fam Med. 2012;25 Suppl 1:S34–8.CrossRefPubMed Pedersen KM, Andersen JS, Sondergaard J. General practice and primary health care in Denmark. J Am Board Fam Med. 2012;25 Suppl 1:S34–8.CrossRefPubMed
11.
go back to reference Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011;378(9802):1560–71.CrossRefPubMedPubMedCentral Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011;378(9802):1560–71.CrossRefPubMedPubMedCentral
12.
go back to reference Roland MO, Morris RW. A study of the natural history of back pain. Part 1: Development of a reliable and sensitive measure of disability in low back pain. Spine. 1983;8:141–4.CrossRefPubMed Roland MO, Morris RW. A study of the natural history of back pain. Part 1: Development of a reliable and sensitive measure of disability in low back pain. Spine. 1983;8:141–4.CrossRefPubMed
13.
go back to reference Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders. Introduction. Spine (Phila Pa 1976). 2000;25(24):3097–9.CrossRef Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders. Introduction. Spine (Phila Pa 1976). 2000;25(24):3097–9.CrossRef
14.
go back to reference Ramsey SD, Willke RJ, Glick H, Reed SD, Augustovski F, Jonsson B, et al. Cost-effectiveness analysis alongside clinical trials II—an ISPOR Good Research Practices Task Force report. Value Health. 2015;18(2):161–72.CrossRefPubMed Ramsey SD, Willke RJ, Glick H, Reed SD, Augustovski F, Jonsson B, et al. Cost-effectiveness analysis alongside clinical trials II—an ISPOR Good Research Practices Task Force report. Value Health. 2015;18(2):161–72.CrossRefPubMed
15.
go back to reference 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;9:140.CrossRefPubMedPubMedCentral 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;9:140.CrossRefPubMedPubMedCentral
16.
go back to reference Harrell FE. Regression modeling strategies. With application to linear models, logistic and ordinal regressions, and survival analysis. 2nd ed. Cham: Springer; 2015. Harrell FE. Regression modeling strategies. With application to linear models, logistic and ordinal regressions, and survival analysis. 2nd ed. Cham: Springer; 2015.
17.
go back to reference Wu S, Crespi CM, Wong WK. Comparison of methods for estimating the intraclass correlation coefficient for binary responses in cancer prevention cluster randomized trials. Contemp Clin Trials. 2012;33(5):869–80.CrossRefPubMedPubMedCentral Wu S, Crespi CM, Wong WK. Comparison of methods for estimating the intraclass correlation coefficient for binary responses in cancer prevention cluster randomized trials. Contemp Clin Trials. 2012;33(5):869–80.CrossRefPubMedPubMedCentral
18.
go back to reference Campbell MK, Piaggio G, Elbourne DR, for the CONSORT Group, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345, e5661.CrossRefPubMed Campbell MK, Piaggio G, Elbourne DR, for the CONSORT Group, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345, e5661.CrossRefPubMed
19.
go back to reference Squires JE, Sullivan K, Eccles MP, Worswick J, Grimshaw JM. Are multifaceted interventions more effective than single-component interventions in changing health-care professionals’ behaviours? An overview of systematic reviews. Implement Sci. 2014;9:152-014-0152-6. Squires JE, Sullivan K, Eccles MP, Worswick J, Grimshaw JM. Are multifaceted interventions more effective than single-component interventions in changing health-care professionals’ behaviours? An overview of systematic reviews. Implement Sci. 2014;9:152-014-0152-6.
20.
go back to reference Dey P, Simpson CW, Collins SI, Hodgson G, Dowrick CF, Simison AJ, Rose MJ. Implementation of RCGP guidelines for acute low back pain: a cluster randomised controlled trial. Br J Gen Pract. 2004;54(498):33–7.PubMedPubMedCentral Dey P, Simpson CW, Collins SI, Hodgson G, Dowrick CF, Simison AJ, Rose MJ. Implementation of RCGP guidelines for acute low back pain: a cluster randomised controlled trial. Br J Gen Pract. 2004;54(498):33–7.PubMedPubMedCentral
21.
go back to reference Becker A, Leonhardt C, Kochen MM, Keller S, Wegscheider K, Baum E, et al. Effects of two guideline implementation strategies on patient outcomes in primary care: a cluster randomized controlled trial. Spine (Phila Pa 1976). 2008;33(5):473–80.CrossRef Becker A, Leonhardt C, Kochen MM, Keller S, Wegscheider K, Baum E, et al. Effects of two guideline implementation strategies on patient outcomes in primary care: a cluster randomized controlled trial. Spine (Phila Pa 1976). 2008;33(5):473–80.CrossRef
22.
go back to reference Engers AJ, Wensing M, van Tulder MW, Timmermans A, Oostendorp RA, Koes BW, et al. Implementation of the Dutch low back pain guideline for general practitioners: a cluster randomized controlled trial. Spine (Phila Pa 1976). 2005;30(6):559–600.CrossRef Engers AJ, Wensing M, van Tulder MW, Timmermans A, Oostendorp RA, Koes BW, et al. Implementation of the Dutch low back pain guideline for general practitioners: a cluster randomized controlled trial. Spine (Phila Pa 1976). 2005;30(6):559–600.CrossRef
23.
go back to reference French SD, McKenzie JE, O’Connor DA, Grimshaw JM, Mortimer D, Francis JJ, et al. Evaluation of a theory-informed implementation intervention for the management of acute low back pain in general medical practice: the IMPLEMENT cluster randomised trial. PLoS One. 2013;8(6), e65471.CrossRefPubMedPubMedCentral French SD, McKenzie JE, O’Connor DA, Grimshaw JM, Mortimer D, Francis JJ, et al. Evaluation of a theory-informed implementation intervention for the management of acute low back pain in general medical practice: the IMPLEMENT cluster randomised trial. PLoS One. 2013;8(6), e65471.CrossRefPubMedPubMedCentral
24.
go back to reference Bishop PB, Wing PC. Knowledge transfer in family physicians managing patients with acute low back pain: a prospective randomized control trial. Spine J. 2006;6(3):282–8.CrossRefPubMed Bishop PB, Wing PC. Knowledge transfer in family physicians managing patients with acute low back pain: a prospective randomized control trial. Spine J. 2006;6(3):282–8.CrossRefPubMed
25.
go back to reference Ip IK, Gershanik EF, Schneider LI, Raja AS, Mar W, Seltzer S, et al. Impact of IT-enabled intervention on MRI use for back pain. Am J Med. 2014;127(6):512–8. e1.CrossRefPubMedPubMedCentral Ip IK, Gershanik EF, Schneider LI, Raja AS, Mar W, Seltzer S, et al. Impact of IT-enabled intervention on MRI use for back pain. Am J Med. 2014;127(6):512–8. e1.CrossRefPubMedPubMedCentral
26.
go back to reference Foster NE, Mullis R, Hill JC, Lewis M, Whitehurst DG, Doyle C, et al. Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison. Ann Fam Med. 2014;12(2):102–11.CrossRefPubMedPubMedCentral Foster NE, Mullis R, Hill JC, Lewis M, Whitehurst DG, Doyle C, et al. Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison. Ann Fam Med. 2014;12(2):102–11.CrossRefPubMedPubMedCentral
27.
go back to reference Morso L, Albert H, Kent P, Manniche C, Hill J. Translation and discriminative validation of the STarT Back Screening Tool into Danish. Eur Spine J. 2011;20(12):2166–73.CrossRefPubMedPubMedCentral Morso L, Albert H, Kent P, Manniche C, Hill J. Translation and discriminative validation of the STarT Back Screening Tool into Danish. Eur Spine J. 2011;20(12):2166–73.CrossRefPubMedPubMedCentral
29.
go back to reference Takeyachi Y, Konno S, Otani K, Yamauchi K, Takahashi I, Suzukamo Y, et al. Correlation of low back pain with functional status, general health perception, social participation, subjective happiness, and patient satisfaction. Spine (Phila Pa 1976). 2003;28(13):1461–6. discussion 1467. Takeyachi Y, Konno S, Otani K, Yamauchi K, Takahashi I, Suzukamo Y, et al. Correlation of low back pain with functional status, general health perception, social participation, subjective happiness, and patient satisfaction. Spine (Phila Pa 1976). 2003;28(13):1461–6. discussion 1467.
30.
go back to reference Hoy D, March L, Brooks P, Woolf A, Blyth F, Vos T, et al. Measuring the global burden of low back pain. Best Pract Res Clin Rheumatol. 2010;24(2):155–65.CrossRefPubMed Hoy D, March L, Brooks P, Woolf A, Blyth F, Vos T, et al. Measuring the global burden of low back pain. Best Pract Res Clin Rheumatol. 2010;24(2):155–65.CrossRefPubMed
Metadata
Title
A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice: a cluster randomised controlled trial
Authors
Allan Riis
Cathrine Elgaard Jensen
Flemming Bro
Helle Terkildsen Maindal
Karin Dam Petersen
Mette Dahl Bendtsen
Martin Bach Jensen
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2015
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-016-0509-0

Other articles of this Issue 1/2015

Implementation Science 1/2015 Go to the issue