Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain
- Conditions
- Back Pain, Low
- Interventions
- Behavioral: Usual careBehavioral: Physiotherapist-led primary care model for back pain
- Registration Number
- NCT04287413
- Lead Sponsor
- Jordan Miller, PT, PhD
- 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:
1. 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.
2. 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1560
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care 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. Physiotherapist-led primary care model for back pain 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).
- Primary Outcome Measures
Name Time Method Self-reported Disability 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)
Self-reported Pain Intensity Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups 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)
Health Related Quality of Life Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups Measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)
Pain Self Efficacy Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups 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)
Global Rating of Change Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups 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)
Satisfaction with Health Care 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups 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)
Fear of Movement Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups Measured using the Tampa Scale of Kinesiophobia (TSK-11) \[an 11-item questionnaire\]. Score of 11-44 with lower scores indicating less pain-related fear. The initial protocol indicated our intention to use the TSK-17, but we changed to the TSK-11 to reduce response burden prior to initiating patient recruitment.
Catastrophic Thinking Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups Measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
Depressive Symptoms Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups Measured using the 2-item Patient Health Questionnaire (PHQ-2) (0 to 6 with greater scores indicating increased depressive symptoms). This measure was changed from the PHQ-9 to PHQ-2 after initial trial registration but prior to initiating patient recruitment reduce response burden.
Adverse Events 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups 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.
- Secondary Outcome Measures
Name Time Method Health Care Accessibility Baseline Percentage of patients receiving care within 48 hours.
Access to Physiotherapy Services Baseline Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.
Health care utilization - electronic medical record (EMR) 12 months Measuring health care utilization, from the participant's EMR, of consultations with primary care team members and access to programs offered within primary care
Health care utilization - self report 12 months 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.
Health care utilization - self-report 12 months Measuring health care utilization from self-report survey: 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. The collection of this healthcare utilization data changed from using health administrative data in Ontario accessed through the Institute for Clinical Evaluative Sience (IC/ES) to using a self-report survey prior to the initiation of patient recrutiment when we recruited sites in British Columbia.
Costs 12 months 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.
Medications Prescribed for Back Pain Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups Measured as a process outcome - medications prescribed for back pain will be collected in table format from the EMR.
Number of Diagnostic Imaging Tests Ordered Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up Measured as a process outcome - the number of diagnostic imaging tests ordered will be collected in table format from the EMR.
Number of Referrals Made to Other Health Care Providers Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up Measured as a process outcome - the number of referrals made to other health care providers will be collected in table format from the EMR.
Number of Notes Written to Employers or Insurers Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up Measured as a process outcome - the number of notes written to employers or insurers will be collected in table format from the EMR.
Education Provided by Health Care Provider Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up Measured as a process outcome (yes or no) and collected in table format from from the EMR
Exercises Prescribed Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up Measured as a process outcome and collected in table format from the EMR
Self-Report Time Lost 6-week, 12-week, 6-month, 9-month, and 12-month follow-up Self-reported time lost from work, volunteering, homemaking, and educational activities
Self-Report Assistance Needed for Activities of Daily Living 6-week, 12-week, 6-month, 9-month, and 12-month follow-up Self-reported assistance needed, due to LBP, for self-care, housework, shopping, or transportation. Participants indicates on survey what they needed assistance for.
Extra Expenses 6-week, 12-week, 6-month, 9-month, and 12-month follow-up Any extra expenses incurred as a result of LBP. Self-report
Trial Locations
- Locations (2)
Interior Health
🇨🇦Kelowna, British Columbia, Canada
Queen's University
🇨🇦Kingston, Ontario, Canada