Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain - a Cluster Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 739
- Locations
- 2
- Primary Endpoint
- Self-reported Disability
Study Overview
Brief Summary
This is a cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for back pain in Canada.
Detailed Description
This study aims to evaluate the individual health outcomes and health system impacts of implementing a new physiotherapist-led primary care model for people with low back pain (LBP).
The overarching goal of this study is to determine the impact of integrating a physiotherapist (PT) within primary care teams for people with LBP and making them available to patients as the first point of contact. The specific aims of the research are to determine:
- Whether a PT-led primary care model for LBP is effective at improving function (primary outcome), pain intensity, quality of life, global rating of change, and adverse events in comparison to usual physician led primary care.
- The impact of a PT led primary care model for LBP on the healthcare system and society (healthcare access, primary care physician workload, healthcare utilization, missed work, and cost-effectiveness). A process evaluation will assess the healthcare delivered, potential mechanisms, context of implementation, and perspectives of patients and primary care providers towards the PT-led primary care model.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Due to the nature of the new model of care and comparison, it is not possible to blind the patients or health care providers. Since the primary outcomes are self-reported outcome measures, the assessor is also not blind to the intervention.
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (19 years and over) with low back pain of any duration who are seeking primary care for back pain at a participating site (primary care visit may be a first or repeat visit).
Exclusion Criteria
- •Patients who do not consent to participation
- •Patients who report being unable to understand, read, and write English
- •Patients for whom the cause of their back pain is cancer
Arms & Interventions
Physiotherapist-led primary care model for back pain
The index intervention will incorporate a PT within the primary care team and make them available at the first point of contact for people with low back pain. There will be 4 key components of this intervention: 1) Initial assessment and screening; 2) Brief individualized intervention at first visit; 3) Health services navigation; 4) Providing additional PT care for people with an unmet need (e.g., no insurance coverage for PT).
Intervention: Physiotherapist-led primary care model for back pain (Behavioral)
Usual care
The physician-led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada. This usually includes a visit to a primary care physician, who would perform a history and physical examination, provide LBP education, order diagnostic imaging, prescribe medications and/or refer based on their assessment findings and patient preferences.
Intervention: Usual care (Behavioral)
Outcomes
Primary Outcomes
Self-reported Disability
Time Frame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)
Secondary Outcomes
- Pain Self Efficacy(Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups)
- Self-reported Pain Intensity(Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups)
- Health Related Quality of Life(Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups)
- Global Rating of Change(Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups)
- Satisfaction with Health Care(6-week, 12-week, 6-month, 9-month, and 12-month follow-ups)
- Fear of Movement(Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups)
- Catastrophic Thinking(Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups)
- Depressive Symptoms(Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups)
- Adverse Events(6-week, 12-week, 6-month, 9-month, and 12-month follow-ups)
- Health Care Accessibility(Baseline)
- Access to Physiotherapy Services(Baseline)
- Health care utilization - electronic medical record (EMR)(12 months)
- Health care utilization - self report(12 months)
- Health care utilization - self-report(12 months)
- Costs(12 months)
- Medications Prescribed for Back Pain(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups)
- Number of Diagnostic Imaging Tests Ordered(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Number of Referrals Made to Other Health Care Providers(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Number of Notes Written to Employers or Insurers(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Education Provided by Health Care Provider(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Exercises Prescribed(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Self-Report Time Lost(6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Self-Report Assistance Needed for Activities of Daily Living(6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Extra Expenses(6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
Investigators
Jordan Miller, PT, PhD
Assistant Professor, School of Rehabilitation Therapy, Queen's University
Queen's University