Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain
Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L 3N6
- Queen's University
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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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.
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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.
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The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Recruitment of primary care teams
Time Frame: Baseline
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Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
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Baseline
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Recruitment of patient participants
Time Frame: Baseline to 14 weeks
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Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
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Baseline to 14 weeks
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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.
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Percentage of all assessment items completed by participants completing each assessment
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Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
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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.
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Attrition rate
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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.
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Physiotherapist confidence in carrying out the interventions
Time Frame: Baseline
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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.
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Baseline
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Treatment fidelity
Time Frame: 6-week follow-up
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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.
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6-week follow-up
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-reported disability
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Self-reported pain intensity
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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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)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health Related Quality of Life
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Global rating of change
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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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)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Satisfaction with health care
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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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)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Catastrophic Thinking
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Depressive symptoms
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the 9-item Patient Health Questionnaire (PHQ-9) (0 to 27 with greater scores indicating increased depressive symptoms)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Adverse events
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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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.
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health care accessibility
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Percentage of patients receiving care within 48 hours.
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health care accessibility
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health care utilization
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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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
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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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
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Includes all health care costs plus societal costs using a human capital approach for loss of productivity
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Medications prescribed
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Diagnostic imaging ordered
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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referrals to other health care providers made
Time Frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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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
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Jordan Miller, PhD, Queen's University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 6021536
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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