Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2020

Open Access 01-12-2020 | Knee Osteoarthritis | Study protocol

Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial

Authors: Bryan Yijia Tan, Michelle Jessica Pereira, Su-Yin Yang, David J. Hunter, Soren Thorgaard Skou, Julian Thumboo, Josip Car

Published in: BMC Musculoskeletal Disorders | Issue 1/2020

Login to get access

Abstract

Background

Knee Osteoarthritis (OA) is a leading cause of global disability. The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT) Model of Care (MoC) was developed by optimizing evidence-based non-surgical treatments to deliver value-based care for people with knee OA. The primary aim of this study is to determine the clinical effectiveness of the CONNACT MoC (3 months) compared to usual care. The secondary aims are: a) To determine the cost-effectiveness and b) To develop an evaluation and implementation framework to inform large scale implementation for this MoC.

Methodology

Type 1 Effectiveness-Implementation Hybrid Trial using an explanatory sequential mixed-method approach. The study consists of 3 components. The first component is the pragmatic, parallel-arm, single-blinded randomized control trial. Inclusion criteria are patients with knee OA based on the National Institute of Health and Care Excellence (NICE) criteria with radiographic severity of greater than Kellgren-Lawrence 1, and Knee Injury and OA Outcome Score (KOOS4) of equal or less than 75. Exclusion criteria include other forms of arthritis, history of previous knee arthroplasty or wheelchair-bound patient. KOOS4 is the primary outcome measure at 3 months, 6 months and 1 year. Secondary outcomes include KOOS individual subscales, quality of life scoring, functional performance, global, diet and psychological related outcomes. The second component is an economic evaluation of the cost-effectiveness of the CONNACT MoC using a societal perspective. The third component is an implementation and evaluation framework using process evaluation under the RE-AIM framework using a mixed-method approach. Sample size of 100 patients has been calculated.

Discussion

CONNACT MoC is a complex intervention. In line with the MRC guidance for developing and evaluating complex interventions, a pilot feasibility study was completed and a comprehensive approach including an RCT, economic evaluation and process evaluation is described in this study protocol. Results from this study will help clinicians, healthcare administrators and policymakers guide the sustainable and effective implementation of the CONNACT MoC for knee OA and serve as a basis for similar multidisciplinary MoC for chronic degenerative musculoskeletal conditions to be developed.

Trial registration

Clinicaltrials.​gov Identifier: NCT03809975. Registered January 182,019.
Appendix
Available only for authorised users
Literature
1.
Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, et al. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73(7):1323–30.PubMedCrossRef
2.
McGrory B, Weber K, Lynott JA, Richmond JC, Davis CM 3rd, Yates A Jr, et al. The American Academy of Orthopaedic surgeons evidence-based clinical practice guideline on surgical Management of Osteoarthritis of the knee. J Bone Joint Surg Am. 2016;98(8):688–92.PubMedCrossRef
3.
McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthr Cartil. 2014;22(3):363–88.CrossRef
4.
Australian Institute for Health and Welfare (2010). Use of health services for arthritis and osteoporosis, in Arthritis Series no. 14. Cat. no. PHE 130. AIHW:Canberra.
5.
Basedow M, Esterman A. Assessing appropriateness of osteoarthritis care using quality indicators: a systematic review. J Eval Clin Pract. 2015;21(5):782–9.PubMedCrossRef
6.
Hagen KB, Smedslund G, Osteras N, Jamtvedt G. Quality of community-based osteoarthritis care: a systematic review and meta-analysis. Arthritis Care Res (Hoboken). 2016;68(10):1443–52.CrossRef
7.
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780–5.PubMedCrossRef
8.
Coggon D, Reading I, Croft P, McLaren M, Barrett D, Cooper C. Knee osteoarthritis and obesity. Int J Obes Relat Metab Dis. 2001;25(5):622–7.CrossRef
9.
Mulcahy H, Chew FS. Current concepts in knee replacement: complications. AJR Am J Roentgenol. 2014;202(1):W76–86.PubMedCrossRef
10.
Grover A, Joshi A. An overview of chronic disease models: a systematic literature review. Global J Health Sci. 2014;7(2):210–27.CrossRef
11.
Allen KD, Choong PF, Davis AM, Dowsey MM, Dziedzic KS, Emery C, et al. Osteoarthritis: models for appropriate care across the disease continuum. Best Pract Res Clin Rheumatol. 2016;30(3):503–35.PubMedCrossRef
12.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ (Clin Res ed). 2008;337:a1655.
13.
Tan BY, Ding BTK, Pereira MJ, Skou ST, Thumboo J, Car J. Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals Trial (CONNACT) – A Feasibility Study in patients with knee osteoarthritis using a mixed method approach. PREPRINT (Version 1) available at Research Square. 2020.
14.
Peters D, Tran N, Adam T, Alliance for Health Policy and Systems Research, World Health Organization. Implementation research in health: a practical guide. 2013.
15.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–26.PubMedPubMedCentralCrossRef
16.
Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011;104(12):510–20.PubMedPubMedCentralCrossRef
17.
Klesges LM, Estabrooks PA, Dzewaltowski DA, Bull SS, Glasgow RE. Beginning with the application in mind: designing and planning health behavior change interventions to enhance dissemination. Ann Behav Med. 2005;29(2):66–75.PubMedCrossRef
18.
Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ (Clin Res ed). 2015;350:h2147.
19.
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(3):200–7.PubMedPubMedCentralCrossRef
20.
McAlindon TE, Driban JB, Henrotin Y, Hunter DJ, Jiang GL, Skou ST, et al. OARSI clinical trials recommendations: design, conduct, and reporting of clinical trials for knee osteoarthritis. Osteoarthr Cartil. 2015;23(5):747–60.CrossRef
21.
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ (Clin Res ed). 2010;340:c869.CrossRef
22.
National Institute for Health and Care Excellence (NICE) Guideline 2014. Osteoarthritis: care and management.
23.
24.
Roos EM, Lohmander LS. The knee injury and osteoarthritis outcome score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1:64.PubMedPubMedCentralCrossRef
25.
Tan BY, Ding BTK, Pereira MJ, Skou ST, Thumboo J, Car J. Collaborative model of care between Orthopaedics and allied healthcare professionals trial (CONNACT) - a feasibility study in patients with knee osteoarthritis using a mixed method approach. BMC Musculoskelet Disord. 2020;21(1):592.PubMedPubMedCentralCrossRef
26.
Sanders JO, Murray J, Gross L. Non-arthroplasty treatment of osteoarthritis of the knee. J Am Acad Orthop Surg. 2014;22(4):256–60.PubMedCrossRef
27.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.PubMedCrossRef
28.
Slade S, Dionne C, Underwood M, Buchbinder R, Beck B, Bennell K, et al. Consensus on exercise reporting template (CERT): modified Delphi study. Phys Ther. 2016;96.
29.
American College of Sport Medicine (ACSM) Guidelines for Exercise Testing and Prescription.
30.
Skou ST, Roos EM. Good life with osteoArthritis in Denmark (GLA:D): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017;18(1):72.PubMedPubMedCentralCrossRef
31.
National Institute for Health and Care Excellence (NICE) Guideline 2014. Weight management: lifestyle services for overweight or obese adults. .
32.
Hayes SC SK, Wilson KG. Acceptance and commitment therapy (an experiential approach to behavior change): New York: a division of Guildford publications Inc; 1999.
33.
Yang S-Y, McCracken L. Acceptance and commitment therapy for chronic pain. J Clin Outcomes Manag. 2014;21:134–44.
34.
Ngooi B. What are the crucial components of patient activation interventions? Biomedical Journal of Scientific & Technical Research. 2017;1.
35.
Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009;50(6):613–21.PubMed
36.
Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, et al. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009;24(6):733–8.PubMedPubMedCentralCrossRef
37.
Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005;40(6 Pt 1):1918–30.PubMedPubMedCentralCrossRef
38.
Sharma A, Kudesia P, Shi Q, Gandhi R. Anxiety and depression in patients with osteoarthritis: impact and management challenges. Open Access Rheumatol. 2016;8:103–13.PubMedPubMedCentralCrossRef
39.
Sharma L, Cahue S, Song J, Hayes K, Pai Y-C, Dunlop D. Physical functioning over three years in knee osteoarthritis: role of psychosocial, local mechanical, and neuromuscular factors. Arthritis Rheum. 2003;48(12):3359–70.PubMedCrossRef
40.
Cleeland CS, Ryan KM. Pain assessment: global use of the brief pain inventory. Ann Acad Med Singap. 1994;23(2):129–38.PubMed
41.
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105–21.CrossRefPubMed
42.
Wise BL, Niu J, Zhang Y, Wang N, Jordan JM, Choy E, et al. Psychological factors and their relation to osteoarthritis pain. Osteoarthr Cartil. 2010;18(7):883–7.CrossRef
43.
Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health affairs (Project Hope). 2013;32(2):207–14.CrossRef
44.
Hibbard JH, Greene J, Tusler M. Improving the outcomes of disease management by tailoring care to the patient's level of activation. Am J Manag Care. 2009;15(6):353–60.PubMed
45.
Hsu WC, Araneta MRG, Kanaya AM, Chiang JL, Fujimoto W. BMI cut points to identify at-risk Asian Americans for type 2 diabetes screening. Diabetes Care. 2015;38(1):150.PubMedCrossRef
46.
Yang S-Y, McCracken LM, Moss-Morris R. Psychological treatment needs for chronic pain in Singapore and the relevance of the psychological flexibility model. Pain Med. 2016;18(9):1679–94.
47.
Lally P, van Jaarsveld CHM, Potts HWW, Wardle J. How are habits formed: Modelling habit formation in the real world. Eur J Soc Psychol. 2010;40(6):998–1009.CrossRef
48.
McCarthy CJ. The effectiveness of supplementing a home exercise programme with a class based exercise programme in the treatment of knee osteoarthritis. Effectiveness of Supplementing a Home Exercise Programme With a Class Based Exercise Programme in the Treatment of Knee Osteoarthritis. 2001:1-.
49.
Burke S, Carron A, Eys M, Ntoumanis N, Estabrooks P. Group versus individual approach? A meta-analysis of the effectiveness of interventions to promote physical activity. Sport Exer Psychol Rev. 2005;2.
50.
Messier SP, Callahan LF, Golightly YM, Keefe FJ. OARSI clinical trials recommendations: design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis. Osteoarthr Cartil. 2015;23(5):787–97.CrossRef
51.
EuroQol--a new facility for the measurement of health-related quality of life. Health policy (Amsterdam, Netherlands). 1990;16(3):199–208.
52.
Neelakantan N, Whitton C, Seah S, Koh H, Rebello SA, Lim JY, et al. Development of a Semi-Quantitative Food Frequency Questionnaire to Assess the Dietary Intake of a Multi-Ethnic Urban Asian Population. Nutrients. 2016;8(9).
53.
Scott W, McCracken LM. Patients' impression of change following treatment for chronic pain: global, specific, a single dimension, or many? J Pain. 2015;16(6):518–26.PubMedCrossRef
54.
Dougados M, Moore A, Yu S, Gitton X. Evaluation of the patient acceptable symptom state in a pooled analysis of two multicentre, randomised, double-blind, placebo-controlled studies evaluating lumiracoxib and celecoxib in patients with osteoarthritis. Arthritis Res Ther. 2007;9:R11.PubMedPubMedCentralCrossRef
55.
Kolt GS, Brewer BW, Pizzari T, Schoo AMM, Garrett N. The sport injury rehabilitation adherence scale: a reliable scale for use in clinical physiotherapy. Physiotherapy. 2007;93(1):17–22.CrossRef
56.
Naal FD, Impellizzeri FM, Leunig M. Which is the best activity rating scale for patients undergoing total joint arthroplasty? Clin Orthop Relat Res. 2009;467(4):958–65.PubMedCrossRef
57.
Schoenthaler M, Miernik A, Offner K, Karcz WK, Hauschke D, Sevcenco S, et al. The cumulative analgesic consumption score (CACS): evaluation of a new score to describe postsurgical analgesic consumption as a surrogate parameter for postoperative pain and invasiveness of surgical procedures. Int Braz J Urol. 2014;40(3):330–6.PubMedCrossRef
58.
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–83.PubMedCrossRef
59.
Mahoney FI, Barthel DW. FUNCTIONAL EVALUATION: The BARTHEL index. Maryland State Med J. 1965;14:61–5.
60.
Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br Volume. 1993;75(5):797–8.CrossRef
61.
Skou ST, Rasmussen S, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, et al. The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement: a randomized controlled trial with 1-year follow-up. Osteoarthr Cartil. 2015;23(9):1465–75.CrossRef
62.
Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, et al. Cross-cultural adaptation and validation of Singapore English and Chinese versions of the knee injury and osteoarthritis outcome score (KOOS) in Asians with knee osteoarthritis in Singapore. Osteoarthr Cartil. 2006;14(11):1098–103.CrossRef
63.
Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, et al. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthr Cartil. 2013;21(8):1042–52.CrossRef
64.
Terwee CB, Bouwmeester W, van Elsland SL, de Vet HC, Dekker J. Instruments to assess physical activity in patients with osteoarthritis of the hip or knee: a systematic review of measurement properties. Osteoarthr Cartil. 2011;19(6):620–33.CrossRef
65.
Luo N, Wang P, Thumboo J, Lim YW, Vrijhoef HJ. Valuation of EQ-5D-3L health states in Singapore: modeling of time trade-off values for 80 empirically observed health states. PharmacoEconomics. 2014;32(5):495–507.PubMedCrossRef
66.
Roddy E, Zhang W, Doherty M, Arden NK, Barlow J, Birrell F, et al. Evidence-based recommendations for the role of exercise in the management of osteoarthritis of the hip or knee--the MOVE consensus. Rheumatology (Oxford, England). 2005;44(1):67–73.CrossRef
67.
McLean S, Holden MA, Potia T, Gee M, Mallett R, Bhanbhro S, et al. Quality and acceptability of measures of exercise adherence in musculoskeletal settings: a systematic review. Rheumatology (Oxford, England). 2017;56(3):426–38.
68.
Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, et al. Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine. Jama. 2016;316(10):1093–103.PubMedCrossRef
69.
Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMJ (Clin Res ed). 2013;346:f1049.
70.
Rice DP. Estimating the cost of illness. Am J Public Health Nation’s Health. 1967;57(3):424–40.CrossRef
71.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. PharmacoEconomics. 1993;4(5):353–65.PubMedCrossRef
72.
Pinto D, Robertson MC, Hansen P, Abbott JH. Good agreement between questionnaire and administrative databases for health care use and costs in patients with osteoarthritis. BMC Med Res Methodol. 2011;11:45.PubMedPubMedCentralCrossRef
73.
Davis AM, Kennedy D, Wong R, Robarts S, Skou ST, McGlasson R, et al. Cross-cultural adaptation and implementation of good life with osteoarthritis in Denmark (GLA:D): group education and exercise for hip and knee osteoarthritis is feasible in Canada. Osteoarthr Cartil. 2018;26(2):211–9.CrossRef
74.
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ (Clin Res ed). 2015;350:h1258.
75.
Briggs AM, Jordan JE, Jennings M, Speerin R, Bragge P, Chua J, et al. Supporting the evaluation and implementation of musculoskeletal models of care: a globally informed framework for judging readiness and success. Arthritis Care Res (Hoboken). 2017;69(4):567–77.PubMedCrossRef
76.
Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, et al. Standards for Reporting Implementation Studies (StaRI) Statement. BMJ (Clin Res Ed). 2017;356:i6795.CrossRef
77.
Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117.PubMedPubMedCentralCrossRef
78.
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349–57.PubMedCrossRef
79.
Roos EM, Juhl CB, Roos EM, Juhl CB. Osteoarthritis 2012 year in review: rehabilitation and outcomes. Osteoarthritis Cartilage. 2012;20(12):1477–83.PubMedCrossRef
80.
Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, et al. Designing and evaluating complex interventions to improve health care. BMJ (Clin Res Ed). 2007;334(7591):455–9.CrossRef
Metadata
Title
Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial
Authors
Bryan Yijia Tan
Michelle Jessica Pereira
Su-Yin Yang
David J. Hunter
Soren Thorgaard Skou
Julian Thumboo
Josip Car
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2020
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-020-03695-3

Other articles of this Issue 1/2020

BMC Musculoskeletal Disorders 1/2020 Go to the issue

Study protocol

Better Knee, Better Me™: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis – protocol for a randomized controlled trial

Research article

Appropriate insertion point for percutaneous pedicle screw placement in the lumbar spine using c-arm fluoroscopy: a cadaveric study

Correspondence

Classifications of good versus poor outcome following knee arthroplasty should not be defined using arbitrary criteria

Research article

The clinical efficacy and experience of bipedicular percutaneous vertebroplasty combined with postural reduction in the treatment of Kümmell’s disease

Research article

Risk of tuberculosis in patients with spondyloarthritis: data from a centralized electronic database in Hong Kong

Research article

Comparative study of imaging and histology of sacroiliac joint in normal rats based on IVIM-DWI and DCE-MRI