Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain - a Cluster Randomized Controlled Trial

Conditions
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Back Pain, Low

Intervention / Treatment
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* Behavioral: Physiotherapist-led primary care model for back pain
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a cluster randomized controlled trial randomizing 20 sites to the PT-led primary care model for back pain or to the usual care model
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapist-led primary care model for back pain<br>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). | Behavioral: Physiotherapist-led primary care model for back pain<br>* Assessment and screening: taking a history; screening for red flags, comorbidities, and risk factors of ongoing pain and disability; physical examination. Brief individualized intervention at the first visit: effective communication, cognitive reassurance, a few exercises, and advice/strategies to stay active. Health services navigation: PT assistance with navigating healthcare services based on the assessment findings. First, red-flags requiring emergency or urgent referrals. Next, comorbid conditions that would benefit from care from other healthcare providers. Finally, referral to PT (if appropriate). Providing additional physiotherapy care to people with an unmet need: Additional physiotherapy care will be provided to patients who have an identified need for physiotherapy but no physiotherapy coverage through private or government health insurance plans.<br>|
| Active Comparator: Usual care<br>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. | Behavioral: Usual care<br>* The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Disability | Measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability) | Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups | 
| Risk of persistent pain and disability | Measured using the STaRT Back tool to group participants into low, medium, and high risk groups | Baseline | 
| Self-reported Pain Intensity | Measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity (measured at rest, during walking, and during a lifting task) | Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups | 
| Health Related Quality of Life | Measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life) | Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups | 
| Pain Self Efficacy | Confidence in abilities to participate in usual activities using the Pain Self Efficacy Questionnaire (0-60 score with higher scores indicating higher level of confidence in dealing with pain) | Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups | 
| Fear of Movement | Measured using the Tampa Scale of Kinesiophobia (a 17-item questionnaire). Score of 17-68 with lower scores indicating less kinesiophobia. | Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups | 
| Global Rating of Change | Measured using an 11-point scale (-5 to +5 with negative scores indicating a worsening of physical functioning related to back pain and positive scores indicating an improvement of physical functioning related to back pain) | Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups | 
| Satisfaction with Health Care | Measured using an 11-point scale(-5 to +5 with negative scores indicating a dissatisfaction with health care received and positive scores indicating satisfaction with health care received) | 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups | 
| Catastrophic Thinking | Measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking) | Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups | 
| Depressive Symptoms | Measured using the 9-item Patient Health Questionnaire (PHQ-9) (0 to 27 with greater scores indicating increased depressive symptoms) | Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups | 
| Adverse Events | Measured using an adverse events questionnaire that asks 1) if the patient has experienced any adverse events as a result of the treatments received (yes/no); 2) how long the event lasted (hours or days); 3) how severe the adverse event was (0-10 scale); 4) what adverse events were experienced. | 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Care Accessibility | Percentage of patients receiving care within 48 hours. | Baseline | 
| Access to Physiotherapy Services | Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care. | Baseline | 
| Health care utilization - electronic medical record (EMR) | Measuring health care utilization, from the participant's EMR, of consultations with primary care team members and access to programs offered within primary care | 12 months | 
| Health care utilization - self report | Measuring health care utilization (self-report survey): visits to health professionals outside of the primary care team (e.g. chiropractors, massage therapists, occupational therapists, physiotherapists, social workers), medication use, and visits to walk-in clinics. | 12 months | 
| Health care utilization -Institute for Clinical Evaluative Sciences (IC/ES) linked data | Measuring health care utilization (from linked IC/ES date): diagnostic imaging for the spine, pain injections or interventional procedures received, specialist visits for low back pain, hospital stays related to back pain and dysfunction, and emergency department visits for back pain. | 12 months | 
| Costs | Includes all health care costs (including: primary care visits, emergency department visits, hospitalizations, surgeries, consultations with other health care providers, diagnostic imaging, medications, and other care received by the patient) plus societal costs using a human capital approach for loss of productivity. | 12 months | 
| Medications Prescribed for Back Pain | Measured as a process outcome - medications prescribed for back pain will be collected in table format from the EMR. | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups | 
| Number of Diagnostic Imaging Tests Ordered | Measured as a process outcome - the number of diagnostic imaging tests ordered will be collected in table format from the EMR. | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Number of Referrals Made to Other Health Care Providers | Measured as a process outcome - the number of referrals made to other health care providers will be collected in table format from the EMR. | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Number of Notes Written to Employers or Insurers | Measured as a process outcome - the number of notes written to employers or insurers will be collected in table format from the EMR. | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Education Provided by Health Care Provider | Measured as a process outcome (yes or no) and collected in table format from from the EMR | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Exercises Prescribed | Measured as a process outcome and collected in table format from the EMR | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Self-Report Time Lost | Self-reported time lost from work, volunteering, homemaking, and educational activities | 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Self-Report Assistance Needed for Activities of Daily Living | Self-reported assistance needed, due to LBP, for self-care, housework, shopping, or transportation. Participants indicates on survey what they needed assistance for. | 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Extra Expenses | Any extra expenses incurred as a result of LBP. Self-report | 6-week, 12-week, 6-month, 9-month, and 12-month follow-up |