Evaluation of a structured goal planning and tailored follow-up programme in rehabilitation for patients with rheumatic diseases: protocol for a pragmatic, stepped-wedge cluster randomized trial

BMC Musculoskeletal Disorders

Kåre Birger Hagen²  Sigrid H Wigers⁸  Bente Slungaard⁶  Anne-Lene Sand-Svartrud⁹  Randi W Rørstad⁴  Merete Nielsen⁴  Petter Mowinckel²  Elin Fjerstad³  Siv G Eppeland⁵  Bente Hamnes⁷  Jon Hagfors⁴  Anne Dingsør¹  Turid Dager³  Ingvild Bø⁹  Gunnhild Berdal²  Ingvild Kjeken² 

[1] Department of Rheumatology, Betanien Hospital, Bj. Bjørnsonsgt 6, N-3722 Skien, Norway;National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23 Vinderen, N-0319 Oslo, Norway;National Unit for Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23 Vinderen, N-0319 Oslo, Norway;Norwegian Rheumatism Association, PO Box 2653 Solli, N-0203 Oslo, Norway;Department of Rheumatology, Sørlandet Hospital, Sykehusveien 1, N-4838 Arendal, Norway;Department of Rheumatology, Martina Hansen’s Hospital, Bærum Postterminal, PO Box 23, N-1306 Bærum, Norway;Department of Self-management, Lillehammer Hospital for Rheumatic Diseases, Margrethe Grundtvigs v 6, N-2609 Lillehammer, Norway;Jeløya Kurbad Rehabilitation Centre, Bråtengaten 94, N-1515 Moss, Norway;Department of Rehabilitation, Lillehammer Hospital for Rheumatic Diseases, Margrethe Grundtvigs v 6, N-2609 Lillehammer, Norway

关键词: Stepped-wedge trial;    Follow-up intervention;    Motivational interviewing;    Goal attainment;    Rheumatic diseases;    Rehabilitation;   

Others  :  1127627
DOI  :  10.1186/1471-2474-15-153

 received in 2013-06-25, accepted in 2014-04-09,  发布年份 2014

【 摘 要 】

Background

Comprehensive rehabilitation, involving health professionals from various disciplines, is widely used as an adjunct to pharmacological and surgical treatment in people with rheumatic diseases. However, the evidence for the clinical- and cost-effectiveness of such interventions is limited, and the majority of those who receive rehabilitation are back to their initial health status six to 12 months after discharge.

Methods/design

To evaluate the goal attainment, health effects and cost-effectiveness of a new rehabilitation programme compared to current traditional rehabilitation programmes for people with rheumatic diseases, a stepped-wedge cluster randomized trial will be performed. Patients admitted for rehabilitation at six centres in the south-eastern part of Norway will be invited to participate. In the trial, six participating centres will switch from a control (current rehabilitation programme) to an intervention phase (the new rehabilitation programme) in a randomized order. Supported by recent research, the new programme will be a supplement to the existing programme at each centre, and will comprise four elements designed to enhance and support lifestyle changes introduced in the rehabilitation period: structured goal-planning, motivational interviewing, a self-help booklet and four follow-up telephone calls during the first five months following discharge. The primary outcome will be health-related quality of life and goal attainment, as measured by the Patient Generated Index directly before and after the rehabilitation stay, as well as after six and 12 months. Secondary outcomes will include self-reported pain, fatigue, a global assessment of disease activity and motivation for change (measured on 11-point numeric ratings scales), health-related quality of life as measured by the Short Form 36 Health Survey (SF-36) and utility assessed by the SF6D utility index.

The main analysis will be on an intention to treat basis and will assess the clinical- and cost-effectiveness of the structured goal planning and tailored follow-up rehabilitation programme for patients with rheumatic diseases.

Discussion

The findings will constitute an important contribution to more cost-effective- and evidence-based rehabilitation services for people with rheumatic diseases.

Trial registration

ISRCTN91433175.

【 授权许可】

   
2014 Kjeken et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Uhlig T, Loge JH, Kristiansen IS, Kvien TK: Quantification of reduced health-related quality of life in patients with rheumatoid arthritis compared to the general population. J Rheumatol 2007, 34:1241-1247.
• [2]www who int. World Health Organization: Health topics Rehabilitation. 2013. Available from: URL: http://www.who.int/topics/rehabilitation/en/ webcite
• [3]Levack WM, Taylor K, Siegert RJ, Dean SG, McPherson KM, Weatherall M: Is goal planning in rehabilitation effective? A systematic review. Clin Rehabil 2006, 20:739-755.
• [4]Klokkerud M, Hagen KB, Løchting I, Uhlig T, Kjeken I, Grotle M: Does the content really matter? A study comparing structure, process and outcome of team rehabilitation in two different clinical settings. Scand J Rheumatol 2012, 41:20-28.
• [5]Vliet Vlieland TP, Zwinderman AH, Vandenbroucke JP, Breedveld FC, Hazes JM: A randomized clinical trial of in-patient multidisciplinary treatment versus routine out-patient care in active rheumatoid arthritis. Br J Rheumatol 1996, 35:475-482.
• [6]Scholten C, Brodowicz T, Graninger W, Gardavsky I, Pils K, Pesau B, Eggl-Tyl E, Wanivenhaus A, Zielinski CC: Persistent functional and social benefit 5 years after a multidisciplinary arthritis training program. Arch Phys Med Rehabil 1999, 80:1282-1287.
• [7]Ahlmen M, Sullivan M, Bjelle A: Team versus non-team outpatient care in rheumatoid arthritis. A comprehensive outcome evaluation including an overall health measure. Arthritis Rheum 1988, 31:471-479.
• [8]Wade DT, de Jong BA: Recent advances in rehabilitation. BMJ 2000, 320:1385-1388.
• [9]Holliday RC, Antoun M, Playford ED: A survey of goal-setting methods used in rehabilitation. Neurorehabil Neural Repair 2005, 19:227-231.
• [10]Scobbie L, Dixon D, Wyke S: Goal setting and action planning in the rehabilitation setting: development of a theoretically informed practice framework. Clin Rehabil 2011, 25:468-482.
• [11]Iversen MD, Hammond A, Betteridge N: Self-management of rheumatic diseases: state of the art and future perspectives. Ann Rheum Dis 2010, 69:955-963.
• [12]Soberg HL, Finset A, Roise O, Bautz-Holter E: Identification and comparison of rehabilitation goals after multiple injuries: an ICF analysis of the patients’, physiotherapists’ and other allied professionals’ reported goals. J Rehabil Med 2008, 40:340-346.
• [13]Ceravolo MG: Rehabilitation goals and strategies in Parkinson’s disease. Eur J Phys Rehabil Med 2009, 45:205-208.
• [14]Bloom LF, Lapierre NM, Wilson KG, Curran D, DeForge DA, Blackmer J: Concordance in goal setting between patients with multiple sclerosis and their rehabilitation team. Am J Phys Med Rehabil 2006, 85:807-813.
• [15]Lecomte T, Wallace CJ, Perreault M, Caron J: Consumers’ goals in psychiatric rehabilitation and their concordance with existing services. Psychiatr Serv 2005, 56:209-211.
• [16]Siegert RJ, Taylor WJ: Theoretical aspects of goal-setting and motivation in rehabilitation. Disabil Rehabil 2004, 26:1-8.
• [17]Wade DT: Research into rehabilitation. What is the priority? Clin Rehabil 2001, 15:229-232.
• [18]Scobbie L, Wyke S, Dixon D: Identifying and applying psychological theory to setting and achieving rehabilitation goals. Clin Rehabil 2009, 23:321-333.
• [19]Hoifodt RS, Strom C, Kolstrup N, Eisemann M, Waterloo K: Effectiveness of cognitive behavioural therapy in primary health care: a review. Fam Pract 2011, 28:489-504.
• [20]Vliet Vlieland TP, van den Ende CH: Nonpharmacological treatment of rheumatoid arthritis. Curr Opin Rheumatol 2011, 23:259-264.
• [21]Dissanayake RK, Bertouch JV: Psychosocial interventions as adjunct therapy for patients with rheumatoid arthritis: a systematic review. Int J Rheum Dis 2010, 13:324-334.
• [22]Thompson DR, Chair SY, Chan SW, Astin F, Davidson PM, Ski CF: Motivational interviewing: a useful approach to improving cardiovascular health? J Clin Nurs 2011, 20:1236-1244.
• [23]Heckman CJ, Egleston BL, Hofmann MT: Efficacy of motivational interviewing for smoking cessation: a systematic review and meta-analysis. Tob Control 2010, 19:410-416.
• [24]Smedslund G, Berg RC, Hammerstrom KT, Steiro A, Leiknes KA, Dahl HM, Karlsen K: Motivational interviewing for substance abuse. Cochrane Database Syst Rev 2011, 5:CD008063.
• [25]Burke BL, Arkowitz H, Menchola M: The efficacy of motivational interviewing: a meta-analysis of controlled clinical trials. J Consult Clin Psychol 2003, 71:843-861.
• [26]Britt E, Hudson SM, Blampied NM: Motivational interviewing in health settings: a review. Patient Educ Couns 2004, 53:147-155.
• [27]Miller WR, Rollnick S: Ten things that motivational interviewing is not. Behav Cogn Psychother 2009, 37:129-140.
• [28]Prochaska JO, DiClemente CC, Velicer WF, Rossi JS: Criticisms and concerns of the transtheoretical model in light of recent research. Br J Addict 1992, 87:825-828.
• [29]Wade DT, Smeets RJ, Verbunt JA: Research in rehabilitation medicine: methodological challenges. J Clin Epidemiol 2010, 63:699-704.
• [30]Brodin N, Eurenius E, Jensen I, Nisell R, Opava CH: Coaching patients with early rheumatoid arthritis to healthy physical activity: a multicenter, randomized, controlled study. Arthritis Rheum 2008, 59:325-331.
• [31]Hughes SL, Seymour RB, Campbell RT, Desai P, Huber G, Chang HJ: Fit and Strong!: bolstering maintenance of physical activity among older adults with lower-extremity osteoarthritis. Am J Health Behav 2010, 34:750-763.
• [32]Allen KD, Oddone EZ, Coffman CJ, Datta SK, Juntilla KA, Lindquist JH, Walker TA, Weinberger M, Bosworth HB: Telephone-based self-management of osteoarthritis: A randomized trial. Ann Intern Med 2010, 153:570-579.
• [33]Grotle M, Hagen KB, Uhlig T, Aas E: Cost of illness for patients with arthritis receiving multidisciplinary rehabilitation care. Rehabil Res Pract 2011, 2011:487025.
• [34]The Norwegian Labour and Welfare Administration (NAV): Work and Welfare (Arbeid og Velferd). Oslo: NAV. 1; 2009:1-80.
• [35]Elliot RA, Barber N, Clifford S, Horne R, Hartley E: The cost effectiveness of a telephone-based pharmacy advisory service to improve adherence to newly prescribed medicines. Pharm World Sci 2008, 30:17-23.
• [36]Weinberger M, Tierney WM, Cowper PA, Katz BP, Booher PA: Cost-effectiveness of increased telephone contact for patients with osteoarthritis. A randomized, controlled trial. Arthritis Rheum 1993, 36:243-246.
• [37]Brown CA, Lilford RJ: The stepped wedge trial design: a systematic review. BMC Med Res Methodol 2006, 6:54. BioMed Central Full Text
• [38]Herbert R: Explanatory and Pragmatic Clinical trials. In Clinical Trials Handbook. Edited by Gad SC. New Jersey: John Wiley&Sons, Inc; 2009:1087-1104.
• [39]Klokkerud M, Grotle M, Løchting I, Kjeken I, Hagen KB, Garrat A: Psychometric properties of the Norwegian version of the Patient Generated Index in patients with rheumatic diseases participating in rehabilitation or self-management programmes. Rheumatology (Oxford) 2013, 52:924-932.
• [40]Klokkerud M, Hagen KB, Kjeken I, Bremander A, Horslev-Petersen K, Vlieland TV, Grotle M: Development of a framework identifying domains and elements of importance for arthritis rehabilitation. J Rehabil Med 2012, 44:406-413.
• [41]Dager TN, Kjeken I, Fjerstad E, Hauge MI: “It is about taking grips and not let myself be ravaged by my body”: a qualitative study of outcomes from in-patient multidisciplinary rehabilitation for patients with chronic rheumatic diseases. Disabil Rehabil 2012, 34:910-916.
• [42]Ruta DA, Garratt AM, Leng M, Russell IT, MacDonald LM: A new approach to the measurement of quality of life. The Patient-Generated Index Med Care 1994, 32:1109-1126.
• [43]Martin F, Camfield L, Rodham K, Kliempt P, Ruta D: Twelve years’ experience with the Patient Generated Index (PGI) of quality of life: a graded structured review. Qual Life Res 2007, 16:705-715.
• [44]Ware JE, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30:473-483.
• [45]Loge JH, Kaasa S, Hjermstad MJ, Kvien TK: Translation and performance of the Norwegian SF-36 Health Survey in patients with rheumatoid arthritis. I. Data quality, scaling assumptions, reliability, and construct validity. J Clin Epidemiol 1998, 51:1069-1076.
• [46]Kjeken I, Bo I, Ronningen A, Spada C, Mowinckel P, Hagen KB, Dagfinrud H: A three-week multidisciplinary in-patient rehabilitation programme had positive long-term effects in patients with ankylosing spondylitis: randomized controlled trial. J Rehabil Med 2013, 45:260-267.
• [47]Bandura A, O′Leary A, Taylor CB, Gauthier J, Gossard D: Perceived self-efficacy and pain control: opioid and nonopioid mechanisms. J Pers Soc Psychol 1987, 53:563-571.
• [48]Lorig K, Chastain RL, Ung E, Shoor S, Holman HR: Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum 1989, 32:37-44.
• [49]Lillegraven S, Kristiansen IS, Kvien TK: Comparison of utility measures and their relationship with other health status measures in 1041 patients with rheumatoid arthritis. Ann Rheum Dis 2010, 69:1762-1767.
• [50]Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P: International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003, 35:1381-1395.
• [51]Lochting I, Garrat A, Klokkerud M, Fjerstad E: Development of the Rheumatic Disease Illness Perception Questionnaire (RD-IPQ) reliability, validity and responsiveness. Clin Exp Rheumatol 2012, 30:308.
• [52]Weinman J, Petrie KJ, Moss-Morris R, Horne R: The illness perception questionnaire: a new method for assessing the cognitive representation of illness. Psychol Health 1996, 11:431-445.
• [53]Kvale S: Interviews: an introduction to qualitative research interviewing. 1st edition. Thousand Oaks, California: Sage; 1996.
• [54]WHO: International Classification of Functioning, Disability and Health (ICF). Geneva: World Health Organization; 2001.
• [55]Faraway JJ: Extending the Linear Model with R: Generalized Linear, Mixed Effects and Nonparametric Regression Models. London: Chapman & Hall/CRC; 2005.
• [56]Faraway J: Changes to the Mixed Effects Models chapters in ELM. 2013. http://www.maths.bath.ac.uk/~jjf23/ELM/mixchange.pdf webcite. 26-2-2014
• [57]Vliet Vlieland TP: Non-drug care for RA–is the era of evidence-based practice approaching? Rheumatology (Oxford) 2007, 46:1397-1404.
• [58]Vliet Vlieland TP: Multidisciplinary team care and outcomes in rheumatoid arthritis. Curr Opin Rheumatol 2004, 16:153-156.