Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain

Study Overview
=================
Brief Summary
-----------------
This is a pilot cluster randomized controlled trial to determine the feasibility of a cluster randomized trial to evaluate the individual and health system impact of implementing a new physiotherapist-led primary care model for back pain in Canada.

Detailed Description
-----------------
This study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in Ontario to evaluate the individual health outcomes and health system impact of implementing a new physiotherapist-led primary care model for people with back pain. The primary purpose of this pilot study is to determine the feasibility including recruitment and retention of primary care teams (sites) and patient participants, carrying out the assessment procedures, and implementing the physiotherapist-led primary care intervention including training the physiotherapist to adopt this role.

Official Title
-----------------
Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial

Conditions
-----------------
Back Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 years and over) with back pain of any duration 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a pilot cluster randomized controlled trial randomizing 4 sites to the PT-led primary care model for back pain or 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 PT-led primary care model for back pain will involve incorporating a PT within the primary care team at the first point of contact for people with back pain at no cost to the patient. Patients in this model will be given the choice of seeing the PT or family doctor. They will be encouraged to book with the PT except when the primary reason for visit is for medication renewals or when the patient has additional health concerns that need attention from their physician in the same visit. There will be 4 key components of the PT led primary care intervention: 1) Initial assessment and screening; 2) Brief individualized intervention at the first visit; 3) Health services navigation; 4) Providing additional PT care for people with an unmet need. | 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, and prescribe medications and/or refer based on their assessment findings and patient preferences. | Other: 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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment of primary care teams | Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate | Baseline | 
| Recruitment of patient participants | Recruitment rate (participants/week) or total number of participants recruited in 14 weeks | Baseline to 14 weeks | 
| Assessment completion | Percentage of all assessment items completed by participants completing each assessment | Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up. | 
| Retention of patient participants | Attrition rate | Retention of participants at 6-week, 12-week, 6, 9, and 12-month follow-up assessments. The primary timeline for this outcome is 12-month follow-up. | 
| Physiotherapist confidence in carrying out the interventions | The PT will rate his/her confidence in each component of the intervention after the training on a scale from 0-10 with higher scores indicating greater confidence in carrying out that component of the intervention. | Baseline | 
| Treatment fidelity | Treatment fidelity will be measured by consistency with the intervention described in the protocol measured through an intervention checklist completed by the physiotherapist and an audit of the EMR notes. | 6-week follow-up | 

Secondary 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) | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| 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) | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| 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) | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| 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) | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| 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) | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Catastrophic Thinking | measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking) | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Depressive symptoms | measured using the 9-item Patient Health Questionnaire (PHQ-9) (0 to 27 with greater scores indicating increased depressive symptoms) | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| 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. | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Health care accessibility | Percentage of patients receiving care within 48 hours. | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Health care accessibility | Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care. | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Health care utilization | All health care visits (aggregated and dis-aggregated) 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 | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Costs (piloted for a cost utility analysis in a future trial) | Includes all health care costs plus societal costs using a human capital approach for loss of productivity | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Medications prescribed | Measured as a process outcome | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| Diagnostic imaging ordered | Measured as a process outcome | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| referrals to other health care providers made | Measured as a process outcome | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up | 
| notes made by primary care provider to employers or insurers | Measured as a process outcome | Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up |