Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain - a Cluster Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Back Pain, Low
- Sponsor
- Jordan Miller, PT, PhD
- Enrollment
- 1560
- Locations
- 2
- Primary Endpoint
- Self-reported Disability
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
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: 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.
Investigators
Jordan Miller, PT, PhD
Assistant Professor, School of Rehabilitation Therapy, Queen's University
Queen's University
Eligibility Criteria
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
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)
Self-reported Pain Intensity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)