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

Overview

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.

Full Title of Study: “Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 15, 2019

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.

Interventions

  • Behavioral: Physiotherapist-led primary care model for back pain
    • 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.
  • Other: Usual care
    • The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Arms, Groups and Cohorts

  • Experimental: Physiotherapist-led primary care model for back pain
    • 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.
  • Active Comparator: 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, and prescribe medications and/or refer based on their assessment findings and patient preferences.

Clinical Trial Outcome Measures

Primary Measures

  • Recruitment of primary care teams
    • Time Frame: Baseline
    • Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
  • Recruitment of patient participants
    • Time Frame: Baseline to 14 weeks
    • Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
  • Assessment completion
    • Time Frame: Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
    • Percentage of all assessment items completed by participants completing each assessment
  • Retention of patient participants
    • Time Frame: 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.
    • Attrition rate
  • Physiotherapist confidence in carrying out the interventions
    • Time Frame: Baseline
    • 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.
  • Treatment fidelity
    • Time Frame: 6-week follow-up
    • 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.

Secondary Measures

  • Self-reported disability
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)
  • Self-reported pain intensity
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • 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: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)
  • Global rating of change
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • 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: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • 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)
  • Catastrophic Thinking
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
  • Depressive symptoms
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • measured using the 9-item Patient Health Questionnaire (PHQ-9) (0 to 27 with greater scores indicating increased depressive symptoms)
  • Adverse events
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • 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.
  • Health care accessibility
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • Percentage of patients receiving care within 48 hours.
  • Health care accessibility
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.
  • Health care utilization
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • 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
  • Costs (piloted for a cost utility analysis in a future trial)
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • Includes all health care costs plus societal costs using a human capital approach for loss of productivity
  • Medications prescribed
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • Measured as a process outcome
  • Diagnostic imaging ordered
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • Measured as a process outcome
  • referrals to other health care providers made
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • Measured as a process outcome
  • notes made by primary care provider to employers or insurers
    • Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
    • Measured as a process outcome

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Queen’s University
  • Collaborator
    • Canadian Institutes of Health Research (CIHR)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jordan Miller, PT, PhD, Assistant Professor, School of Rehabilitation Therapy – Queen’s University
  • Overall Official(s)
    • Jordan Miller, PhD, Principal Investigator, Queen’s University

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