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

Open Access 01-12-2015 | Study protocol

Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial

Authors: Nina Østerås, Leti van Bodegom-Vos, Krysia Dziedzic, Tuva Moseng, Eline Aas, Øyvor Andreassen, Ibrahim Mdala, Bård Natvig, Jan Harald Røtterud, Unni-Berit Schjervheim, Thea Vliet Vlieland, Kåre Birger Hagen

Published in: Implementation Science | Issue 1/2015

Login to get access

Abstract

Background

Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8–12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model.

Methods/design

A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants’ treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER).

Discussion

The results from the present study will add to the current knowledge on tailored strategies, which aims to improve the uptake of evidence-based OA care recommendations and improve the quality of OA care in primary health care. The new knowledge can be used in national and international initiatives designed to improve the quality of OA care.

Trial registration

ClinicalTrials.gov NCT02333656
Appendix
Available only for authorised users
Literature
1.
go back to reference Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011;377:2115–26.CrossRefPubMed Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011;377:2115–26.CrossRefPubMed
2.
go back to reference National Clinical Guideline Centre. Osteoarthritis. In: Care and management in adults. London (UK): National Institute for Health and Care Excellence (NICE); 2014. p. 36. Clinical guideline; no. 177. National Clinical Guideline Centre. Osteoarthritis. In: Care and management in adults. London (UK): National Institute for Health and Care Excellence (NICE); 2014. p. 36. Clinical guideline; no. 177.
3.
go back to reference Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the global burden of disease study 2010. Lancet. 2013;380:2163–96.CrossRef Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the global burden of disease study 2010. Lancet. 2013;380:2163–96.CrossRef
4.
go back to reference Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009;15:S230–S5.PubMed Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009;15:S230–S5.PubMed
5.
go back to reference Ghomrawi HM, Schackman BR, Mushlin AI. Appropriateness criteria and elective procedures—total joint arthroplasty. N Engl J Med. 2012;367:2467–9.CrossRefPubMed Ghomrawi HM, Schackman BR, Mushlin AI. Appropriateness criteria and elective procedures—total joint arthroplasty. N Engl J Med. 2012;367:2467–9.CrossRefPubMed
6.
go back to reference Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012;64:455–74.CrossRef Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012;64:455–74.CrossRef
9.
go back to reference Referansegruppen for muskel- skjelettlidelser i Norsk Forening for Allmennmedisin. Råd og anbefalinger for riktig bruk av bildediagnostikk ved muskel-skjelettlidelser i allmennpraksis. Oslo: Norsk Forening for Allmennmedisin; 2010. Referansegruppen for muskel- skjelettlidelser i Norsk Forening for Allmennmedisin. Råd og anbefalinger for riktig bruk av bildediagnostikk ved muskel-skjelettlidelser i allmennpraksis. Oslo: Norsk Forening for Allmennmedisin; 2010.
10.
go back to reference Werner EL, Gross DP. The effects of a media campaign on beliefs and utilization of imaging examinations in Norwegian patients with low back pain. Nor Epidemiol. 2009;19:73–8. Werner EL, Gross DP. The effects of a media campaign on beliefs and utilization of imaging examinations in Norwegian patients with low back pain. Nor Epidemiol. 2009;19:73–8.
11.
go back to reference Porcheret M, Jordan K, Croft P. Treatment of knee pain in older adults in primary care: development of an evidence-based model of care. Rheumatology (Oxford). 2007;46:638–48.CrossRef Porcheret M, Jordan K, Croft P. Treatment of knee pain in older adults in primary care: development of an evidence-based model of care. Rheumatology (Oxford). 2007;46:638–48.CrossRef
12.
go back to reference Smink AJ, van den Ende CH, Vliet Vlieland TP, Swierstra BA, Kortland JH, Bijlsma JW, et al. “Beating osteoARThritis”: development of a stepped care strategy to optimize utilization and timing of non-surgical treatment modalities for patients with hip or knee osteoarthritis. Clin Rheumatol. 2011;30:1623–9.CrossRefPubMed Smink AJ, van den Ende CH, Vliet Vlieland TP, Swierstra BA, Kortland JH, Bijlsma JW, et al. “Beating osteoARThritis”: development of a stepped care strategy to optimize utilization and timing of non-surgical treatment modalities for patients with hip or knee osteoarthritis. Clin Rheumatol. 2011;30:1623–9.CrossRefPubMed
13.
go back to reference Smink AJ, Dekker J, Vliet Vlieland TP, Swierstra BA, Kortland JH, Bijlsma JW, et al. Health care use of patients with osteoarthritis of the hip or knee after implementation of a stepped-care strategy: an observational study. Arthritis Care Res (Hoboken). 2014;66:817–27. doi:10.1002/acr.22222.CrossRef Smink AJ, Dekker J, Vliet Vlieland TP, Swierstra BA, Kortland JH, Bijlsma JW, et al. Health care use of patients with osteoarthritis of the hip or knee after implementation of a stepped-care strategy: an observational study. Arthritis Care Res (Hoboken). 2014;66:817–27. doi:10.​1002/​acr.​22222.CrossRef
14.
go back to reference Smink AJ, van den Ende CH, Vliet Vlieland TP, Bijlsma JW, Swierstra BA, Kortland JH, et al. Effect of stepped care on health outcomes in patients with osteoarthritis: an observational study in Dutch general practice. Br J Gen Pract. 2014;64:e538–44. doi:10.3399/bjgp14X681337.CrossRefPubMedPubMedCentral Smink AJ, van den Ende CH, Vliet Vlieland TP, Bijlsma JW, Swierstra BA, Kortland JH, et al. Effect of stepped care on health outcomes in patients with osteoarthritis: an observational study in Dutch general practice. Br J Gen Pract. 2014;64:e538–44. doi:10.​3399/​bjgp14X681337.CrossRefPubMedPubMedCentral
15.
go back to reference Dziedzic KS, Healey EL, Porcheret M, Ong B, Main CJ, Jordan KP, et al. Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care—the Management of OsteoArthritis In Consultations (MOSAICS) study protocol. Implement Sci. 2014;9:95. doi:10.1186/s13012-014-0095-y.CrossRefPubMedPubMedCentral Dziedzic KS, Healey EL, Porcheret M, Ong B, Main CJ, Jordan KP, et al. Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care—the Management of OsteoArthritis In Consultations (MOSAICS) study protocol. Implement Sci. 2014;9:95. doi:10.​1186/​s13012-014-0095-y.CrossRefPubMedPubMedCentral
17.
go back to reference Thorstensson CA, Garellick G, Rystedt H, Dahlberg LE. Better management of patients with osteoarthritis: development and nationwide implementation of an evidence-based supported osteoarthritis self-management programme. Musculoskeletal Care. 2014. doi:10.1002/msc.1085. Thorstensson CA, Garellick G, Rystedt H, Dahlberg LE. Better management of patients with osteoarthritis: development and nationwide implementation of an evidence-based supported osteoarthritis self-management programme. Musculoskeletal Care. 2014. doi:10.​1002/​msc.​1085.
19.
go back to reference Norwegian Directorate of Health. Avklaring av ansvars-og oppgavedeling mellom kommunene og spesialisthelsetjenesten på rehabiliteringsområdet IS-1947. Oslo: The Norwegian Directorate of Health; 2012. Norwegian Directorate of Health. Avklaring av ansvars-og oppgavedeling mellom kommunene og spesialisthelsetjenesten på rehabiliteringsområdet IS-1947. Oslo: The Norwegian Directorate of Health; 2012.
20.
go back to reference Østeras N, Garratt A, Grotle M, Natvig B, Kjeken I, Kvien TK, et al. Patient-reported quality of care for osteoarthritis: development and testing of the osteoarthritis quality indicator questionnaire. Arthritis Care Res (Hoboken). 2013;65:1043–51. doi:10.1002/acr.21976.CrossRef Østeras N, Garratt A, Grotle M, Natvig B, Kjeken I, Kvien TK, et al. Patient-reported quality of care for osteoarthritis: development and testing of the osteoarthritis quality indicator questionnaire. Arthritis Care Res (Hoboken). 2013;65:1043–51. doi:10.​1002/​acr.​21976.CrossRef
22.
go back to reference Finset A. One size does not fit all: how to talk to patients about obesity. Patient Educ Couns. 2009;76:147–8.CrossRefPubMed Finset A. One size does not fit all: how to talk to patients about obesity. Patient Educ Couns. 2009;76:147–8.CrossRefPubMed
24.
go back to reference Jamtvedt G, Dahm KT, Holm I, Flottorp S. Measuring physiotherapy performance in patients with osteoarthritis of the knee: a prospective study. BMC Health Serv Res. 2008;8:145.CrossRefPubMedPubMedCentral Jamtvedt G, Dahm KT, Holm I, Flottorp S. Measuring physiotherapy performance in patients with osteoarthritis of the knee: a prospective study. BMC Health Serv Res. 2008;8:145.CrossRefPubMedPubMedCentral
25.
go back to reference Norwegian Knowledge Centre for the Health Services. Effects of organised follow-up of behaviour that may increase risk of disease in adults. Oslo: Norwegian Knowledge Centre for the Health Services; Report No.: 978-82-8121-497-2. 2012. Norwegian Knowledge Centre for the Health Services. Effects of organised follow-up of behaviour that may increase risk of disease in adults. Oslo: Norwegian Knowledge Centre for the Health Services; Report No.: 978-82-8121-497-2. 2012.
26.
go back to reference Norwegian Directorate of Health. Guide for primary health care frisklivssentraler. Establishment and organising. Oslo: Norwegian Directorate of Health; 2013. In Norwegian. Norwegian Directorate of Health. Guide for primary health care frisklivssentraler. Establishment and organising. Oslo: Norwegian Directorate of Health; 2013. In Norwegian.
27.
go back to reference Denison E UV, Berg RC, Vist GE. Effects of more than three months organized follow-up on physical activity and diet for people with increased risk of lifestyle related disease [In Norwegian]. Report no. 16−2014. Oslo: Norwegian Knowledge Centre for the Health Services; 2014. Denison E UV, Berg RC, Vist GE. Effects of more than three months organized follow-up on physical activity and diet for people with increased risk of lifestyle related disease [In Norwegian]. Report no. 16−2014. Oslo: Norwegian Knowledge Centre for the Health Services; 2014.
28.
go back to reference Norwegian Ministry of Health Care Services. National health and care services plan. Oslo: Norwegian Ministry of Health Care Services; 2011. In Norwegian. Norwegian Ministry of Health Care Services. National health and care services plan. Oslo: Norwegian Ministry of Health Care Services; 2011. In Norwegian.
29.
go back to reference Oxman AD, Thomson MA, Davis DA, Haynes RB. No magic bullets: a systematic review of 102 trials of interventions to improve professional practice. CMAJ. 1995;153:1423–31.PubMedPubMedCentral Oxman AD, Thomson MA, Davis DA, Haynes RB. No magic bullets: a systematic review of 102 trials of interventions to improve professional practice. CMAJ. 1995;153:1423–31.PubMedPubMedCentral
30.
go back to reference Aakhus E, Flottorp SA, Oxman AD. Implementing evidence-based guidelines for managing depression in elderly patients: a Norwegian perspective. Epidemiol Psychiatr Sci. 2012;21:237–40.CrossRefPubMed Aakhus E, Flottorp SA, Oxman AD. Implementing evidence-based guidelines for managing depression in elderly patients: a Norwegian perspective. Epidemiol Psychiatr Sci. 2012;21:237–40.CrossRefPubMed
31.
go back to reference Grol R, Wensing M. What drives change? Barriers to and incentives for achieving evidence-based practice. Med J Aust. 2004;180:S57–60.PubMed Grol R, Wensing M. What drives change? Barriers to and incentives for achieving evidence-based practice. Med J Aust. 2004;180:S57–60.PubMed
32.
go back to reference Sanders T, Foster NE, Ong BN. Perceptions of general practitioners towards the use of a new system for treating back pain: a qualitative interview study. BMC Med. 2011;9:49.CrossRefPubMedPubMedCentral Sanders T, Foster NE, Ong BN. Perceptions of general practitioners towards the use of a new system for treating back pain: a qualitative interview study. BMC Med. 2011;9:49.CrossRefPubMedPubMedCentral
33.
go back to reference Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, et al. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999;282:1458–65.CrossRefPubMed Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, et al. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999;282:1458–65.CrossRefPubMed
35.
go back to reference Bernhardsson S, Johansson K, Nilsen P, Oberg B, Larsson ME. Determinants of guideline use in primary care physical therapy: a cross-sectional survey of attitudes, knowledge, and behavior. Phys Ther. 2014;94:343–54. doi:10.2522/ptj.20130147.CrossRefPubMed Bernhardsson S, Johansson K, Nilsen P, Oberg B, Larsson ME. Determinants of guideline use in primary care physical therapy: a cross-sectional survey of attitudes, knowledge, and behavior. Phys Ther. 2014;94:343–54. doi:10.​2522/​ptj.​20130147.CrossRefPubMed
37.
go back to reference Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S et al. Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2010:CD005470. doi:10.1002/14651858.CD005470.pub2. Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S et al. Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2010:CD005470. doi:10.​1002/​14651858.​CD005470.​pub2.
39.
go back to reference Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMed Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMed
40.
go back to reference Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309.CrossRefPubMed Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309.CrossRefPubMed
42.
go back to reference Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, et al. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004;12:389–99.CrossRefPubMed Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, et al. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004;12:389–99.CrossRefPubMed
43.
go back to reference Stratford P, Gill C, Westaway M, Binkley J. Assessing disability and change on individual patients: a report of a patient specific measure. Physiother Can. 1995;47:258–63.CrossRef Stratford P, Gill C, Westaway M, Binkley J. Assessing disability and change on individual patients: a report of a patient specific measure. Physiother Can. 1995;47:258–63.CrossRef
44.
go back to reference Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS)—validation of a Swedish version. Scand J Med Sci Sports. 1998;8:439–48.CrossRefPubMed Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS)—validation of a Swedish version. Scand J Med Sci Sports. 1998;8:439–48.CrossRefPubMed
45.
go back to reference Klassbo M, Larsson E, Mannevik E. Hip disability and osteoarthritis outcome score. An extension of the Western Ontario and McMaster Universities Osteoarthritis Index. Scand J Rheumatol. 2003;32:46–51.CrossRefPubMed Klassbo M, Larsson E, Mannevik E. Hip disability and osteoarthritis outcome score. An extension of the Western Ontario and McMaster Universities Osteoarthritis Index. Scand J Rheumatol. 2003;32:46–51.CrossRefPubMed
46.
go back to reference Norwegian Ministry of Health Care Services. The coordination reform. Proper treatment—at the right place and right time. Oslo: Norwegian Ministry of Health Care Services; 2009. Norwegian Ministry of Health Care Services. The coordination reform. Proper treatment—at the right place and right time. Oslo: Norwegian Ministry of Health Care Services; 2009.
47.
go back to reference Kurtze N, Rangul V, Hustvedt BE, Flanders WD. Reliability and validity of self-reported physical activity in the Nord-Trondelag health study: HUNT 1. Scand J Public Health. 2008;36:52–61.CrossRefPubMed Kurtze N, Rangul V, Hustvedt BE, Flanders WD. Reliability and validity of self-reported physical activity in the Nord-Trondelag health study: HUNT 1. Scand J Public Health. 2008;36:52–61.CrossRefPubMed
48.
go back to reference Skudal KE, Garratt AM, Eriksson B, Leinonen T, Simonsen J, Bjertnaes OA. The Nordic Patient Experiences Questionnaire (NORPEQ): cross-national comparison of data quality, internal consistency and validity in four Nordic countries. BMJ Open. 2012;2. Skudal KE, Garratt AM, Eriksson B, Leinonen T, Simonsen J, Bjertnaes OA. The Nordic Patient Experiences Questionnaire (NORPEQ): cross-national comparison of data quality, internal consistency and validity in four Nordic countries. BMJ Open. 2012;2.
49.
go back to reference EuroQo LG. EuroQol—a new facility for the measurement of health-related quality of life. The Euro Qol Group Health Policy. 1990;16:199–208.CrossRef EuroQo LG. EuroQol—a new facility for the measurement of health-related quality of life. The Euro Qol Group Health Policy. 1990;16:199–208.CrossRef
50.
go back to reference Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q ExercSport. 1999;70:113–9.CrossRef Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q ExercSport. 1999;70:113–9.CrossRef
51.
go back to reference American Thoracic S. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166:111–7.CrossRef American Thoracic S. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166:111–7.CrossRef
52.
go back to reference Cataneo DC, Cataneo AJ. Accuracy of the stair climbing test using maximal oxygen uptake as the gold standard. J Bras Pneumol. 2007;33:128–33.CrossRefPubMed Cataneo DC, Cataneo AJ. Accuracy of the stair climbing test using maximal oxygen uptake as the gold standard. J Bras Pneumol. 2007;33:128–33.CrossRefPubMed
Metadata
Title
Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial
Authors
Nina Østerås
Leti van Bodegom-Vos
Krysia Dziedzic
Tuva Moseng
Eline Aas
Øyvor Andreassen
Ibrahim Mdala
Bård Natvig
Jan Harald Røtterud
Unni-Berit Schjervheim
Thea Vliet Vlieland
Kåre Birger Hagen
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2015
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-015-0353-7

Other articles of this Issue 1/2015

Implementation Science 1/2015 Go to the issue