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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Back Pain, Low
• Intervention / Treatment: Behavioral: Physiotherapist-led primary care model for back pain; Behavioral: Usual care

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.

• Study Type: Interventional
• Enrollment (Estimated): 1560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordan Miller, PhD; Phone Number: 905-872-9938; Email: jordan.miller@queensu.ca
• Study Contact Backup: Name: Kevin Varette, Msc; Phone Number: 613-888-5943; Email: varettek@queensu.ca

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 0C5
      • Recruiting
      • Interior Health
      • Contact: Jordan Miller
  • Ontario
    • Kingston, Ontario, Canada, K7L 3N6
      • Recruiting
      • Queen's University
      • Contact: Jordan Miller

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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, order diagnostic imaging, prescribe medications and/or refer based on their assessment findings and patient preferences.	Behavioral: Usual care; The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
Experimental: 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).	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comorbidities	Measured at baseline using the Functional Comorbidity Index (an 18-item list of comorbidities that are associated with physical functioning).	Baseline
Baseline characteristics	To describe the study population, the investigators will capture the following through the survey: age, sex, gender, identification as indigenous (First Nations, Inuit, Métis), duration and history of LBP, level of education achieved, household income, and work status.	Baseline
Participant Treatment Fidelity	Self-report adherence to physiotherapy advice	6-weeks

Collaborators and Investigators

• Sponsor: Jordan Miller, PT, PhD
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Jordan Miller, PhD, Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 2, 2025

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: REH-755-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No