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

Abstract

BackgroundBack 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:Determine feasibility of patient recruitment, assessment procedures, and retention.Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP)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. MethodsThis 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.DiscussionIf 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 registrationClinicalTrials.gov, NCT03320148. Submitted for registration on 17 September 2017.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2279-7) contains supplementary material, which is available to authorized users.

Self-reported use of family physician, chiropractor and physiotherapy services among adult Canadians with chronic back disorders: an observational study

“…The first and last recommendations of the 2017 Canadian Guideline for Opiods for Chronic Non-cancer Pain [32] include referral to multidisciplinary non-physician care providers; however, given the access barriers to these services, these guidelines become challenging to follow in many clinical settings. Several models of care that include physiotherapists or chiropractors within primary care settings have shown benefit [33–36], and others that are attempting to overcome access barriers are being investigated [37, 38].…”

Implementing a new physiotherapist-led primary care model for low back pain: a qualitative study of patient and primary care team perspectives

“…We chose an interpretive description approach as it is well suited for qualitative research within the context of healthcare that has practical application [ 28 ]. This study was nested within a pilot cluster randomized controlled trial that set out to determine the feasibility of implementing the new physiotherapist-led primary care model for LBP [ 27 ].…”

“…Participants were recruited from interprofessional primary care teams (i.e., Family Health Teams [ 30 ] and Community Health Centres [ 31 ]) in Kingston, Ontario, Canada that participated in the new physiotherapist-led primary care model for LBP as part of a pilot cluster randomized trial [ 27 ].…”

“…In the new model of care, physiotherapists were integrated within primary care teams and able to deliver first contact care with no out-of-pocket costs to patients with LBP [ 27 ]. In the pilot study, patients who called to book an appointment with their family physician at their primary care site were invited to see a physiotherapist as their first point of contact if their primary reason for the visit was LBP [ 27 ].…”

“…We implemented a new physiotherapist-led primary care model for LBP as part of a pilot cluster randomized controlled trial [ 27 ]. In this model of care, a physiotherapist was integrated directly within a primary care team and available as the first point of contact who could provide additional care for patients with LBP and an unmet need for treatment.…”