Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain
- Conditions
- Back Pain
- Interventions
- Other: Usual careBehavioral: Physiotherapist-led primary care model for back pain
- Registration Number
- NCT03320148
- Lead Sponsor
- Queen's University
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- Patients who do not consent to participation
- Patients who report being unable to understand, read, and write English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care 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. Physiotherapist-led primary care model for back pain 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.
- Primary Outcome Measures
Name Time Method Recruitment of primary care teams Baseline Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
Recruitment of patient participants Baseline to 14 weeks Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
Assessment completion 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 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 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 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 Outcome Measures
Name Time Method Self-reported disability 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 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 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 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 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 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)
Adverse events 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 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 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
Depressive symptoms 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)
Costs (piloted for a cost utility analysis in a future trial) 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 Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up Measured as a process outcome
Diagnostic imaging ordered 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 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 Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up Measured as a process outcome
Trial Locations
- Locations (1)
Queen's University
🇨🇦Kingston, Ontario, Canada