Back Pain
Conditions
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.
Interventions
1. Assessment and screening: taking a history; screening for red flags, comorbidities, and risk factors of ongoing pain and disability; physical examination 2. Brief individualized intervention at the first visit: effective communication, cognitive reassurance, a few exercises, and advice/strategies to stay active. 3. 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). 4. 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.
OTHERUsual care
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
Sponsors
Canadian Institutes of Health Research (CIHR)
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Due to the nature of the new model of care and comparison, it is not possible to blind the patients or health care providers. Since the primary outcomes are self-reported outcome measures, the assessor is also not blind to the intervention.
Intervention model description
This is a pilot cluster randomized controlled trial randomizing 4 sites to the PT-led primary care model for back pain or usual care model
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 receiving care within 48 hours. |
| 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 |
| 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 |
| 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 |
| 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) |
Countries
Canada
Outcome results
None listed