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

Back Pain, Low Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04287413
• Other study ID #: REH-755-19
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: October 2, 2025

Study information

• Verified date: October 2023
• Source: Queen's University
• Contact: Jordan Miller, PhD
• Phone: 905-872-9938
• Email: jordan.miller[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1560
• Est. completion date: October 2, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain, Low
• Low Back Pain

Intervention

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.
• Usual care
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Locations

Country	Name	City	State
Canada	Interior Health	Kelowna	British Columbia
Canada	Queen's University	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Jordan Miller, PT, PhD	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comorbidities	Measured at baseline using the Functional Comorbidity Index (an 18-item list of comorbidities that are associated with physical functioning).	Baseline
Other	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
Other	Participant Treatment Fidelity	Self-report adherence to physiotherapy advice	6-weeks
Primary	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
Primary	Risk of persistent pain and disability	Measured using the STaRT Back tool to group participants into low, medium, and high risk groups	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Health Care Accessibility	Percentage of patients receiving care within 48 hours.	Baseline
Secondary	Access to Physiotherapy Services	Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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