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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2021

01-12-2021 | Osteoarthrosis | Study protocol

Task shifting in the care for patients with hand osteoarthritis. Protocol for a randomized controlled non-inferiority trial

Authors: Ingvild Kjeken, Kjetil Bergsmark, Ida K. Haugen, Toril Hennig, Merete Hermann-Eriksen, Vivian Tryving Hornburg, Åshild Hove, Anne Prøven, Trine Amalie Sjøvold, Barbara Slatkowsky-Christensen

Published in: BMC Musculoskeletal Disorders | Issue 1/2021

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Abstract

Background

Current health policy states that patients with osteoarthritis (OA) should mainly be managed in primary health care. Still, research shows that patients with hand OA have poor access to recommended treatment in primary care, and in Norway, they are increasingly referred to rheumatologist consultations in specialist care. In this randomized controlled non-inferiority trial, we will test if a new model, where patients referred to consultation in specialist health care receive their first consultation by an occupational therapy (OT) specialist, is as safe and effective as the traditional model, where they receive their first consultation by a rheumatologist. More specifically, we will answer the following questions:
1.
What are the characteristics of patients with hand OA referred to specialist health care with regards to joint affection, disease activity, symptoms and function?
 
2.
Is OT-led hand OA care as effective and safe as rheumatologist-led care with respect to treatment response, disease activity, symptoms, function and patient satisfaction?
 
3.
Is OT-led hand OA care equal to, or more cost effective than rheumatologist-led care?
 
4.
Which factors, regardless of hand OA care, predict improvement 6 and 12 months after baseline?
 

Methods

Participants will be patients with hand OA diagnosed by a general practitioner and referred for consultation at one of two Norwegian departments of rheumatology. Those who agree will attend a clinical assessment and report their symptoms and function in validated outcome measures, before they are randomly selected to receive their first consultation by an OT specialist (n = 200) or by a rheumatologist (n = 200). OTs may refer patients to a rheumatologist consultation and vice versa. The primary outcome will be the number of patients classified as OMERACT/OARSI-responders after six months. Secondary outcomes are pain, function and satisfaction with care over the twelve-month trial period. The analysis of the primary outcome will be done by logistic regression. A two-sided 95% confidence interval for the difference in response probability will be formed, and non-inferiority of OT-led care will be claimed if the upper endpoint of this interval does not exceed 15%.

Discussion

The findings will improve access to evidence-based management of people with hand OA.

Trial registration

ClinicalTrials.gov, NCT03102788. Registered April 6th, 2017, https://clinicaltrials.gov/ct2/show/NCT03102788?term=Kjeken&draw=2&rank=1
Date and version identifier:
December 17th, 2020. First version.
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;73:1323–30.PubMedCrossRef
2.
Marshall M, Watt FE, Vincent TL, Dziedzic K. Hand osteoarthritis: clinical phenotypes, molecular mechanisms and disease management. Nat Rev Rheumatol. 2018;14:641–56.PubMedCrossRef
3.
Botha-Scheepers S, Riyazi N, Watt I, Rosendaal FR, Slagboom E, Bellamy N, et al. Progression of hand osteoarthritis over 2 years: a clinical and radiological follow-up study. Ann Rheum Dis. 2009;68:1260–4.PubMedCrossRef
4.
Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, et al. EULAR evidence-based recommendations for the diagnosis of hand osteoarthritis: report of a task force of ESCISIT. Ann Rheum Dis. 2009;68:8–17.PubMedCrossRef
5.
Qin J, Barbour KE, Murphy LB, Nelson AE, Schwartz TA, Helmick CG, et al. Lifetime Risk of Symptomatic Hand Osteoarthritis: The Johnston County Osteoarthritis Project. Arthritis Rheumatol (Hoboken, NJ). 2017;69:1204–12.CrossRef
6.
Kwok WY, Vliet Vlieland TP, Rosendaal FR, Huizinga TW, Kloppenburg M. Limitations in daily activities are the major determinant of reduced health-related quality of life in patients with hand osteoarthritis. Ann Rheum Dis. 2011;70:334–6.PubMedCrossRef
7.
Kingsbury SR, Gross HJ, Isherwood G, Conaghan PG. Osteoarthritis in Europe: impact on health status, work productivity and use of pharmacotherapies in five European countries. Rheumatology (Oxford). 2014;53:937–47.CrossRef
8.
Slatkowsky-Christensen B, Mowinckel P, Kvien TK. Health status and perception of pain: a comparative study between female patients with hand osteoarthritis and rheumatoid arthritis. Scand J Rheumatol. 2009;38:342–8.PubMedCrossRef
9.
Kloppenburg M, Kroon FP, Blanco FJ, Doherty M, Dziedzic KS, Greibrokk E, et al. 2018 update of the EULAR recommendations for the management of hand osteoarthritis. Ann Rheum Dis. 2019;78:16–24.PubMedCrossRef
10.
11.
Dziedzic KS, Allen KD. Challenges and controversies of complex interventions in osteoarthritis management: recognizing inappropriate and discordant care. Rheumatology (Oxford). 2018;57(suppl_4):iv88–98.CrossRef
12.
Kloppenburg M. Hand osteoarthritis-nonpharmacological and pharmacological treatments. Nat Rev Rheumatol. 2014;10:242–51.PubMedCrossRef
13.
Gravas EMH, Tveter AT, Nossum R, Eide REM, Klokkeide A, Matre KH, et al. Non-pharmacological treatment gap preceding surgical consultation in thumb carpometacarpal osteoarthritis - a cross-sectional study. BMC Musculoskelet Disord. 2019;20:180.PubMedPubMedCentralCrossRef
14.
Ahluwalia V, Larsen TLH, Kennedy CA, Inrig T, Lundon K. An advanced clinician practitioner in arthritis care can improve access to rheumatology care in community-based practice. J Multidiscip Healthc. 2019;12:63–71.PubMedPubMedCentralCrossRef
15.
Dejaco C, Putrik P, Unger J, Aletaha D, Bianchi G, Bijlsma JW, et al. EULAR 'points to consider' for the conduction of workforce requirement studies in rheumatology. RMD open. 2018;4(2):e000780.PubMedPubMedCentralCrossRef
16.
WHO. Task shifting to tackle health worker shortages.; 2007. Contract No.: WHO/HSS/2007.03.
17.
Garner S, Lopatina E, Rankin JA, Marshall DA. Nurse-led Care for Patients with rheumatoid arthritis: a systematic review of the effect on quality of care. J Rheumatol. 2017;44:757–65.PubMedCrossRef
18.
Stanhope J, Beaton K, Grimmer-Somers K, Morris J. The role of extended scope physiotherapists in managing patients with inflammatory arthropathies: a systematic review. Open Access Rheumatol. 2012;4:49–55.PubMedPubMedCentralCrossRef
19.
Thompson J, Yoward S, Dawson P. The role of physiotherapy extended scope practitioners in musculoskeletal care with focus on decision making and clinical outcomes: a systematic review of quantitative and qualitative research. Musculoskeletal Care. 2017;15:91–103.PubMedCrossRef
20.
McPherson K, Kersten P, George S, Lattimer V, Breton A, Ellis B, et al. A systematic review of evidence about extended roles for allied health professionals. J Health Serv Res Policy. 2006;11:240–7.PubMedCrossRef
21.
Saxon RL, Gray MA, Oprescu FI. Extended roles for allied health professionals: an pdated systematic review of the evidence. J Multidiscip Healthc. 2014;7:479–88.PubMedPubMedCentralCrossRef
22.
Dziedzic KS, Hill JC, Porcheret M, Croft PR. New models for primary care are needed for osteoarthritis. Phys Ther. 2009;89:1371–8.PubMedCrossRef
23.
O'Brien L, Hardman A, Goldby S. The impact of a hand therapy screening and management clinic for patients referred for surgical opinion in an Australian public hospital. J Hand Ther. 2013;26:318–22.PubMedCrossRef
24.
Tveter AT, Østerås N, Nossum R, Eide RE, Klokkeide Å, Matre KH, et al. The MAP-Hand: Psychometric properties and differences in activity performance between patients with carpometacarpal osteoarthritis and rheumatoid arthritis. J Rehabil Med. 2020;52(6):jrm00070.PubMedCrossRef
25.
Gravås EMH, Østerås N, Nossum R, Eide REM, Klokkeide Å, Matre KH, et al. Does occupational therapy delay or reduce the proportion of patients that receives thumb carpometacarpal joint surgery? A multicentre randomised controlled trial. RMD Open. 2019;5(2):e001046.PubMedPubMedCentralCrossRef
26.
Burley S, Cox R, Di Tommaso A, Molineux M. Primary contact occupational therapy hand clinics: the pull of an occupational perspective. Aust Occup Ther J. 2018;65:533–43.PubMedCrossRef
27.
Darre S, Nossum R. Task shifting in occupational therapy [Jobbglidning - noe for ergoterapeuter?]. Ergoterapeuten (Norwegian). 2016;2:52–3.
28.
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.PubMedPubMedCentralCrossRef
29.
Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, et al. EULAR evidence based recommendations for the management of hand osteoarthritis: report of a task force of the EULAR standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2007;66(3):377–88.PubMedCrossRef
30.
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(4):465–74.CrossRef
31.
National Clinical Guideline C. National Institute for Health and Clinical Excellence: Guidance. Osteoarthritis: Care and Management in Adults. London: National Institute for Health and Care Excellence (UK). Copyright © National Clinical Guideline Centre; 2014.
32.
Osteras N, Hagen KB, Grotle M, Sand-Svartrud AL, Mowinckel P, Kjeken I. Limited effects of exercises in people with hand osteoarthritis: results from a randomized controlled trial. Osteoarthr Cartil. 2014;22:1224–33.CrossRef
33.
Kjeken I, Smedslund G, Moe RH, Slatkowsky-Christensen B, Uhlig T, Hagen KB. Systematic review of design and effects of splints and exercise programs in hand osteoarthritis. Arthritis Care Res (Hoboken). 2011;63:834–48.PubMedCrossRef
34.
Hennig T, Haehre L, Hornburg VT, Mowinckel P, Norli ES, Kjeken I. Effect of home-based hand exercises in women with hand osteoarthritis: a randomised controlled trial. Ann Rheum Dis. 2015;74:1501–8.PubMedCrossRef
35.
Kjeken I. Occupational therapy-based and evidence-supported recommendations for assessment and exercises in hand osteoarthritis. Scand J Occup Ther. 2011;18:265–81.PubMedCrossRef
36.
Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, et al. Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham osteoarthritis study. Ann Rheum Dis. 2011;70:1581–6.PubMedCrossRef
37.
Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol. 1997;24:799–802.PubMed
38.
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. Osteoarthr Cartil. 2004;12:389–99.CrossRef
39.
Fernandes L, Grotle M, Darre S, Nossum R, Kjeken I. Validity and responsiveness of the measure of activity performance of the hand (MAP-hand) in patients with hand osteoarthritis. J Rehabil Med. 2012;44:869–76.PubMedCrossRef
40.
Moe RH, Garratt A, Slatkowsky-Christensen B, Maheu E, Mowinckel P, Kvien TK, et al. Concurrent evaluation of data quality, reliability and validity of the Australian/Canadian osteoarthritis hand index and the functional index for hand osteoarthritis. Rheumatology (Oxford). 2010;49:2327–36.CrossRef
41.
Ariza-Ariza R, Hernandez-Cruz B, Carmona L, Dolores Ruiz-Montesinos M, Ballina J, Navarro-Sarabia F. Assessing utility values in rheumatoid arthritis: a comparison between time trade-off and the EuroQol. Arthritis Rheum. 2006;55:751–6.PubMedCrossRef
42.
Garratt A, Bjertnaes ØA, Krogstad U, Gulbrandsen P. The patient experiences questionnaire PasOpp in somatic outpatient clinics. Tidsskr Nor Laegeforen. 2005;125:421–4.PubMed
43.
Tveter AT, Dagfinrud H, Moseng T, Holm I. Health-related physical fitness measures: reference values and reference equations for use in clinical practice. Arch Phys Med Rehabil. 2014;95:1366–73.PubMedCrossRef
44.
Wenham CY, Hensor EM, Grainger AJ, Hodgson R, Balamoody S, Dore CJ, et al. A randomized, double-blind, placebo-controlled trial of low-dose oral prednisolone for treating painful hand osteoarthritis. Rheumatology (Oxford). 2012;51:2286–94.CrossRef
45.
Report no. 26 to the Storting (2014–2015). Future primary health care - holistic and close. [Fremtidens primærhelsetjeneste - nærhet og helhet]. The Ministry of Health and Care Services; 2014.
46.
Report no. 11 to the Storting (2014–2015). National health and hospital plan (2016–2019). [Nasjonal helse- og sykehusplan (2014–2015)]. The Ministry of Health and Care Services; 2015.
47.
The Health&Care21 Strategy. [HelseOmsorg21]. The Research Council of Norway; 2014.
Metadata
Title
Task shifting in the care for patients with hand osteoarthritis. Protocol for a randomized controlled non-inferiority trial
Authors
Ingvild Kjeken
Kjetil Bergsmark
Ida K. Haugen
Toril Hennig
Merete Hermann-Eriksen
Vivian Tryving Hornburg
Åshild Hove
Anne Prøven
Trine Amalie Sjøvold
Barbara Slatkowsky-Christensen
Publication date
01-12-2021
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2021
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-021-04019-9

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