Clinical trial NCT04287413: Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain
Official title: Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain - a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Back Pain, Low
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-02-27
Enrollment: 1560
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cluster randomized controlled trial randomizing 20 sites to the PT-led primary care model for back pain or to the usual care model
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self-reported Disability
timeFrame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
measure: Self-reported Pain Intensity
timeFrame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
measure: Health Related Quality of Life
timeFrame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
measure: Pain Self Efficacy
timeFrame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
measure: Global Rating of Change
timeFrame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
measure: Satisfaction with Health Care
timeFrame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
measure: Fear of Movement
timeFrame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
measure: Catastrophic Thinking
timeFrame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
measure: Depressive Symptoms
timeFrame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
measure: Adverse Events
timeFrame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Secondary outcomes:
measure: Health Care Accessibility
timeFrame: Baseline
measure: Access to Physiotherapy Services
timeFrame: Baseline
measure: Health care utilization - electronic medical record (EMR)
timeFrame: 12 months
measure: Health care utilization - self report
timeFrame: 12 months
measure: Health care utilization - self-report
timeFrame: 12 months
measure: Costs
timeFrame: 12 months
measure: Medications Prescribed for Back Pain
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
measure: Number of Diagnostic Imaging Tests Ordered
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Number of Referrals Made to Other Health Care Providers
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Number of Notes Written to Employers or Insurers
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Education Provided by Health Care Provider
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Exercises Prescribed
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Self-Report Time Lost
timeFrame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Self-Report Assistance Needed for Activities of Daily Living
timeFrame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Extra Expenses
timeFrame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Other outcomes:
measure: Comorbidities
timeFrame: Baseline
measure: Baseline characteristics
timeFrame: Baseline
measure: Risk of persistent pain and disability
timeFrame: Baseline
measure: Participant Treatment Fidelity
timeFrame: 6-weeks
Locations:
city: Kelowna
country: Canada
facility: Interior Health
state: British Columbia
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Jordan Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: