Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial

Jordan Miller, David Barber, Catherine Donnelly, Simon French, Michael Green, Jonathan Hill, Joy MacDermid, Jacquelyn Marsh, Kathleen Norman, Julie Richardson, Monica Taljaard, Timothy Wideman, Lynn Cooper, Colleen McPhee, Jordan Miller, David Barber, Catherine Donnelly, Simon French, Michael Green, Jonathan Hill, Joy MacDermid, Jacquelyn Marsh, Kathleen Norman, Julie Richardson, Monica Taljaard, Timothy Wideman, Lynn Cooper, Colleen McPhee

Abstract

Background: Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes.

Methods: This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs from participants in the PT-led primary care sites.

Discussion: If this pilot demonstrates feasibility, a fully powered trial will provide evidence that has the potential to transform primary care for back pain. The full trial will inform future service design, whether these models should be more widely implemented, and training agendas.

Trial registration: ClinicalTrials.gov, NCT03320148 . Submitted for registration on 17 September 2017.

Keywords: Cluster randomized trial; Low back pain; Physiotherapy; Primary care.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval for this protocol has been obtained from the Queen’s University Health Science and Affiliated Teaching Hospitals Research Ethics Board (HSREB #6021536).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Overview of the PT in primary care screening and navigation process. The physiotherapist (PT) will help the patient navigate the healthcare system in three stages. First, any red flags identified will lead to emergency, urgent, or soon referrals to the emergency department, physician, and/or imaging. Second, the patient history, examination findings, and validated questionnaires, when appropriate, will be used to determine if other healthcare providers are needed for this patient’s care. Third, the PT will use the STarT back risk stratification tool (individuals screened as low, medium, or high risk of ongoing pain and disability [27]) to guide referral pathways for physiotherapy. The matched low-risk pathway is a brief primary care intervention (reassurance, advice, and exercise) with no referral. The medium-risk pathway involves a referral for usual physiotherapy care in addition to the brief intervention. The high-risk matched pathway includes referral for a combined physical and psychologically informed treatment approach which aims to address barriers to recovery, facilitate increases in activity, and address unhelpful back pain beliefs and behaviors. This treatment approach has been described in more detail elsewhere [56]. GAD-7 General Anxiety Disorder-7, NSAIDS nonsteroidal anti-inflammatory drugs, OT occupational therapy, PC primary care, PHQ-9 Patient Health Questionnaire-9, PTSD post-traumatic stress disorder
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments

References

    1. Vos T, Flaxman AD, Naghavi 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. 2012;380(9859):2163–96. doi: 10.1016/S0140-6736(12)61729-2.
    1. Bone and Joint Canada . Low back pain. 2014; epidemiology of low back pain. 2016.
    1. Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008;8(1):8–20. doi: 10.1016/j.spinee.2007.10.005.
    1. Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006;88(Suppl 2):21–4.
    1. Singer J. A snapshot of health care in Canada as demonstrated by top 10 lists, 2011. Toronto: Canadian Institute of Health Information; 2011. Available from: . Accessed 15 Sept 2017.
    1. Gandjour A, Telzerow A, Lauterbach KW, INTERCARE International Investigators European comparison of costs and quality in the treatment of acute back pain. Spine (Phila Pa 1976) 2005;30(8):969–75. doi: 10.1097/01.brs.0000158944.54033.60.
    1. Deyo RA, Mirza SK, Martin BI. Back pain prevalence and visit rates: estimates from U.S. national surveys, 2002. Spine (Phila Pa 1976) 2006;31(23):2724–7. doi: 10.1097/.
    1. Lim KL, Jacobs P, Klarenbach S. A population-based analysis of healthcare utilization of persons with back disorders: results from the Canadian Community Health Survey 2000–2001. Spine (Phila Pa 1976) 2006;31(2):212–8. doi: 10.1097/01.brs.0000194773.10461.9f.
    1. Jordan KP, Kadam UT, Hayward R, Porcheret M, Young C, Croft P. Annual consultation prevalence of regional musculoskeletal problems in primary care: an observational study. BMC Musculoskelet Disord. 2010;11:144. doi: 10.1186/1471-2474-11-144.
    1. Hartvigsen J, Foster NE, Croft PR. We need to rethink front line care for back pain. BMJ. 2011;342:d3260. doi: 10.1136/bmj.d3260.
    1. Foster NE, Hartvigsen J, Croft PR. Taking responsibility for the early assessment and treatment of patients with musculoskeletal pain: a review and critical analysis. Arthritis Res Ther. 2012;14(1):205. doi: 10.1186/ar3743.
    1. Pinney SJ, Regan WD. Educating medical students about musculoskeletal problems. Are community needs reflected in the curricula of Canadian medical schools? J Bone Joint Surg Am. 2001;83-A(9):1317–20. doi: 10.2106/00004623-200109000-00004.
    1. Freedman KB, Bernstein J. Educational deficiencies in musculoskeletal medicine. J Bone Joint Surg Am. 2002;84-A(4):604–8. doi: 10.2106/00004623-200204000-00015.
    1. Day CS, Yeh AC, Franko O, Ramirez M, Krupat E. Musculoskeletal medicine: an assessment of the attitudes and knowledge of medical students at Harvard Medical School. Acad Med. 2007;82(5):452–7. doi: 10.1097/ACM.0b013e31803ea860.
    1. Darlow B, Dean S, Perry M, Mathieson F, Baxter GD, Dowell A. Acute low back pain management in general practice: uncertainty and conflicting certainties. Fam Pract. 2014;31(6):723–32. doi: 10.1093/fampra/cmu051.
    1. Information CIoH . Provincial and territorial health system priorities: an environmental scan. 2011.
    1. Fritz JM, Cleland JA, Brennan GP. Does adherence to the guideline recommendation for active treatments improve the quality of care for patients with acute low back pain delivered by physical therapists? Med Care. 2007;45(10):973–80. doi: 10.1097/MLR.0b013e318070c6cd.
    1. Rutten GM, Degen S, Hendriks EJ, Braspenning JC, Harting J, Oostendorp RA. Adherence to clinical practice guidelines for low back pain in physical therapy: do patients benefit? Phys Ther. 2010;90(8):1111–22. doi: 10.2522/ptj.20090173.
    1. Delitto A, George SZ, Van Dillen LR, et al. Low back pain. J Orthop Sports Phys Ther. 2012;42(4):A1–57. doi: 10.2519/jospt.2012.42.4.A1.
    1. Koes BW, van Tulder M, Lin CW, Macedo LG, McAuley J, Maher C. An updated overview of clinical guidelines for the management of non-specific low back pain in primary care. Eur Spine J. 2010;19(12):2075–94. doi: 10.1007/s00586-010-1502-y.
    1. Pillastrini P, Gardenghi I, Bonetti F, et al. An updated overview of clinical guidelines for chronic low back pain management in primary care. Joint Bone Spine. 2012;79(2):176–85. doi: 10.1016/j.jbspin.2011.03.019.
    1. TOP Low Back Pain Guidelines Working Group . Evidence-informed primary care management of low back pain: clinical practice guideline. Edmonton: Toward Optimized Practice; 2015.
    1. Comans T, Raymer M, O'Leary S, Smith D, Scuffham P. Cost-effectiveness of a physiotherapist-led service for orthopaedic outpatients. J Health Serv Res Policy. 2014;19(4):216–23. doi: 10.1177/1355819614533675.
    1. James JJ, Stuart RB. Expanded role for the physical therapist. Screening musculoskeletal disorders. Phys Ther. 1975;55(2):121–31.
    1. Rempel J, Busse JW, Drew B, et al. Patients’ attitudes toward non-physician screening of low back and low back-related leg pain complaints referred for surgical assessment. Spine. 2017;42(5):E288–93.
    1. Childs JD, Whitman JM, Sizer PS, Pugia ML, Flynn TW, Delitto A. A description of physical therapists’ knowledge in managing musculoskeletal conditions. BMC Musculoskelet Disord. 2005;6:32. doi: 10.1186/1471-2474-6-32.
    1. Hill JC, Dunn KM, Main CJ, Hay EM. Subgrouping low back pain: a comparison of the STarT Back tool with the Orebro Musculoskeletal Pain Screening Questionnaire. Eur J Pain. 2010;14(1):83–9. doi: 10.1016/j.ejpain.2009.01.003.
    1. Hill JC, Whitehurst DG, Lewis M, 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. doi: 10.1016/S0140-6736(11)60937-9.
    1. Freburger JK, Carey TS, Holmes GM, et al. Exercise prescription for chronic back or neck pain: who prescribes it? Who gets it? What is prescribed? Arthritis Rheum. 2009;61(2):192–200. doi: 10.1002/art.24234.
    1. Fritz JM, Childs JD, Wainner RS, Flynn TW. Primary care referral of patients with low back pain to physical therapy: impact on future health care utilization and costs. Spine (Phila Pa 1976) 2012;37(25):2114–21. doi: 10.1097/BRS.0b013e31825d32f5.
    1. Childs JD, Fritz JM, Wu SS, et al. Implications of early and guideline adherent physical therapy for low back pain on utilization and costs. BMC Health Serv Res. 2015;15:150. doi: 10.1186/s12913-015-0830-3.
    1. Murphy S, Blake C, Power CK, Fullen BM. The role of clinical specialist physiotherapists in the management of low back pain in a spinal triage clinic. Ir J Med Sci. 2013;182(4):643–50. doi: 10.1007/s11845-013-0945-7.
    1. Bath B, Grona SL, Janzen B. A spinal triage programme delivered by physiotherapists in collaboration with orthopaedic surgeons. Physiother Can. 2012;64(4):356–66. doi: 10.3138/ptc.2011-29.
    1. Donato EB, DuVall RE, Godges JJ, Zimmerman GJ, Greathouse DG. Practice analysis: defining the clinical practice of primary contact physical therapy. J Orthop Sports Phys Ther. 2004;34(6):284–304. doi: 10.2519/jospt.2004.34.6.284.
    1. Greathouse DG, Schreck RC, Benson CJ. The United States Army physical therapy experience: evaluation and treatment of patients with neuromusculoskeletal disorders. J Orthop Sports Phys Ther. 1994;19(5):261–6. doi: 10.2519/jospt.1994.19.5.261.
    1. McGill T. Effectiveness of physical therapists servicing as primary care musculoskeletal providers as compared to family practice providers in a deployed combat location: a retrospective medical chart review. Mil Med. 2013;178(10):1115–20. doi: 10.7205/MILMED-D-13-00066.
    1. Murphy BP, Greathouse D, Matsui I. Primary care physical therapy practice models. J Orthop Sports Phys Ther. 2005;35(11):699–707. doi: 10.2519/jospt.2005.35.11.699.
    1. Ross MD, Childs JD, Middel C, et al. Physical therapist vs. family practitioner knowledge of simple low back pain management in the US Air Force. Mil Med. 2014;179(2):162–8. doi: 10.7205/MILMED-D-13-00099.
    1. Holdsworth LK, Webster VS, McFayden AK. What are the costs to NHS Scotland of self-referral to physiotherapy? Results of a national trial. Physiotherapy. 2007;93:3–11. doi: 10.1016/j.physio.2006.05.005.
    1. Holdsworth LK, Webster VS, McFayden AK. Physiotherapists’ and general practitioners’ views of self-referral and physiotherapy scope of practice: results from a national trial. Physiotherapy. 2008;94.
    1. Webster VS, Holdswort LK, McFayden AK. Self-referral, access and physiotherapy: patients’ knowledge and attitudes. Results of a national trial. Physiotherapy. 2008;94:141–9. doi: 10.1016/j.physio.2007.11.003.
    1. Beasley JW, Hankey TH, Erickson R, et al. How many problems do family physicians manage at each encounter? A WReN study. Ann Fam Med. 2004;2(5):405–10. doi: 10.1370/afm.94.
    1. Roelofs PD, Deyo RA, Koes BW, Scholten RJ, van Tulder MW. Nonsteroidal anti-inflammatory drugs for low back pain: an updated Cochrane review. Spine (Phila Pa 1976) 2008;33(16):1766–74. doi: 10.1097/BRS.0b013e31817e69d3.
    1. Enthoven WT, Roelofs PD, Deyo RA, van Tulder MW, Koes BW. Non-steroidal anti-inflammatory drugs for chronic low back pain. Cochrane Database Syst Rev. 2016;2:CD012087.
    1. Desjardins-Charbonneau A, Roy JS, Thibault J, Ciccone VT, Desmeules F. Acceptability of physiotherapists as primary care practitioners and advanced practice physiotherapists for care of patients with musculoskeletal disorders: a survey of a university community within the province of Quebec. BMC Musculoskelet Disord. 2016;17(1):400. doi: 10.1186/s12891-016-1256-8.
    1. Manea L, Gilbody S, McMillan D. A diagnostic meta-analysis of the Patient Health Questionnaire-9 (PHQ-9) algorithm scoring method as a screen for depression. Gen Hosp Psychiatry. 2015;37(1):67–75. doi: 10.1016/j.genhosppsych.2014.09.009.
    1. Thombs BD, Benedetti A, Kloda LA, et al. The diagnostic accuracy of the Patient Health Questionnaire-2 (PHQ-2), Patient Health Questionnaire-8 (PHQ-8), and Patient Health Questionnaire-9 (PHQ-9) for detecting major depression: protocol for a systematic review and individual patient data meta-analyses. Syst Rev. 2014;3:124. doi: 10.1186/2046-4053-3-124.
    1. Linton SJ. Intricacies of good communication in the context of pain: does validation reinforce disclosure? Pain. 2015;156(2):199–200. doi: 10.1097/01.j.pain.0000460297.25831.67.
    1. Lumley MA, Sklar ER, Carty JN. Emotional disclosure interventions for chronic pain: from the laboratory to the clinic. Transl Behav Med. 2012;2(1):73–81. doi: 10.1007/s13142-011-0085-4.
    1. Gillis ME, Lumley MA, Mosley-Williams A, Leisen JC, Roehrs T. The health effects of at-home written emotional disclosure in fibromyalgia: a randomized trial. Ann Behav Med. 2006;32(2):135–46. doi: 10.1207/s15324796abm3202_11.
    1. Pincus T, Holt N, Vogel S, et al. Cognitive and affective reassurance and patient outcomes in primary care: a systematic review. Pain. 2013;154(11):2407–16. doi: 10.1016/j.pain.2013.07.019.
    1. Gordon R, Bloxham S. A systematic review of the effects of exercise and physical activity on non-specific chronic low back pain. Healthcare (Basel). 2016;4(22):1–19.
    1. Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015;29(12):1155–67. doi: 10.1177/0269215515570379.
    1. Dahm KT, Brurberg KG, Jamtvedt G, Hagen KB. Advice to rest in bed versus advice to stay active for acute low-back pain and sciatica. Cochrane Database Syst Rev. 2010;6:CD007612.
    1. Watson PW, McKinstry B. A systematic review of interventions to improve recall of medical advice in healthcare consultations. J R Soc Med. 2009;102(6):235–43. doi: 10.1258/jrsm.2009.090013.
    1. Main CJ, Sowden G, Hill JC, Watson PJ, Hay EM. Integrating physical and psychological approaches to treatment in low back pain: the development and content of the STarT Back trial’s ‘high-risk’ intervention (StarT Back; ISRCTN 37113406) Physiotherapy. 2012;98(2):110–6. doi: 10.1016/j.physio.2011.03.003.
    1. Hill JC, Afolabi EK, Lewis M, et al. Does a modified STarT Back tool predict outcome with a broader group of musculoskeletal patients than back pain? A secondary analysis of cohort data. BMJ Open. 2016;6(10):e012445. doi: 10.1136/bmjopen-2016-012445.
    1. Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011;92(12):2041–56. doi: 10.1016/j.apmr.2011.07.198.
    1. Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1. doi: 10.1186/1471-2288-10-1.
    1. Schulz KF, Grimes DA. Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet. 2002;359(9308):781–5. doi: 10.1016/S0140-6736(02)07882-0.
    1. Hildebrand MW, Host HH, Binder EF, et al. Measuring treatment fidelity in a rehabilitation intervention study. Am J Phys Med Rehabil. 2012;91(8):715–24. doi: 10.1097/PHM.0b013e31824ad462.
    1. Chiarotto A, Maxwell LJ, Terwee CB, Wells GA, Tugwell P, Ostelo RW. Roland-Morris disability questionnaire and Oswestry disability index: which has better measurement properties for measuring physical functioning in nonspecific low back pain? Systematic review and meta-analysis. Phys Ther. 2016;96(10):1620–37.
    1. Roland M, Fairbank J. The Roland-Morris disability questionnaire and the Oswestry disability questionnaire. Spine (Phila Pa 1976) 2000;25(24):3115–24. doi: 10.1097/00007632-200012150-00006.
    1. Chapman JR, Norvell DC, Hermsmeyer JT, et al. Evaluating common outcomes for measuring treatment success for chronic low back pain. Spine (Phila Pa 1976) 2011;36(21 Suppl):S54–68. doi: 10.1097/BRS.0b013e31822ef74d.
    1. Trost Z. All pain is not created equal: differentiating between pain during movement versus pain at rest following total knee arthroplasty. Pain. 2012;153(11):2161–2. doi: 10.1016/j.pain.2012.07.019.
    1. Sayers A, Wylde V, Lenguerrand E, et al. Rest pain and movement-evoked pain as unique constructs in hip and knee replacements. Arthritis Care Res (Hoboken) 2016;68(2):237–45. doi: 10.1002/acr.22656.
    1. Srikandarajah S, Gilron I. Systematic review of movement-evoked pain versus pain at rest in postsurgical clinical trials and meta-analyses: a fundamental distinction requiring standardized measurement. Pain. 2011;152(8):1734–9. doi: 10.1016/j.pain.2011.02.008.
    1. van Reenan M, Janssen B. EQ-5D-5 L user guide. Version: 2.1. Rotterdam; 2015. Available from: .
    1. Finch AP, Dritsaki M, Jommi C. Generic preference-based measures for low back pain: which of them should be used? Spine (Phila Pa 1976) 2016;41(6):E364–74. doi: 10.1097/BRS.0000000000001247.
    1. Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163–70. doi: 10.1179/jmt.2009.17.3.163.
    1. Fritz JM, Hebert J, Koppenhaver S, Parent E. Beyond minimally important change: defining a successful outcome of physical therapy for patients with low back pain. Spine (Phila Pa 1976) 2009;34(25):2803–9. doi: 10.1097/BRS.0b013e3181ae2bd4.
    1. Sullivan MJL, et al. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7:524–32.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–13. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016;2:64. doi: 10.1186/s40814-016-0105-8.
    1. Ioannidis JP, Evans SJ, Gotzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141(10):781–8. doi: 10.7326/0003-4819-141-10-200411160-00009.
    1. Nice Low Back Pain Working Group . Non-specific low back pain and sciatica: management. 2016.
    1. Ministry of Health and Long-Term Care. Schedule of benefits. Ministry of Health and Long Term Care; 2015.
    1. Campbell MJ. Extending CONSORT to include cluster trials. BMJ. 2004;328(7441):654–5. doi: 10.1136/bmj.328.7441.654.
    1. Campbell MK, Elbourne DR, Altman DG, Group C. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328(7441):702–8. doi: 10.1136/bmj.328.7441.702.
    1. Bombardier C, Hayden J, Beaton DE. Minimal clinically important difference. Low back pain: outcome measures. J Rheumatol. 2001;28(2):431–8.
    1. Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004;57(8):785–94. doi: 10.1016/j.jclinepi.2003.12.013.
    1. Eldridge SM, Ashby D, Kerry S. Sample size for cluster randomized trials: effect of coefficient of variation of cluster size and analysis method. Int J Epidemiol. 2006;35(5):1292–300. doi: 10.1093/ije/dyl129.
    1. Thorne S, Kirkham SR, MacDonald-Emes J. Interpretive description: a noncategorical qualitative alternative for developing nursing knowledge. Res Nurs Health. 1997;20(2):169–77. doi: 10.1002/(SICI)1098-240X(199704)20:2<169::AID-NUR9>;2-I.
    1. Hunt MR. Strengths and challenges in the use of interpretive description: reflections arising from a study of the moral experience of health professionals in humanitarian work. Qual Health Res. 2009;19(9):1284–92. doi: 10.1177/1049732309344612.

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