Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Back Pain
- Sponsor
- Queen's University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Recruitment of primary care teams
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Jordan Miller, PT, PhD
Assistant Professor, School of Rehabilitation Therapy
Queen's University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Recruitment of primary care teams
Time Frame: Baseline
Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
Recruitment of patient participants
Time Frame: Baseline to 14 weeks
Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
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.
Percentage of all assessment items completed by participants completing each assessment
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.
Attrition rate
Physiotherapist confidence in carrying out the interventions
Time Frame: 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
Time Frame: 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 Outcomes
- Self-reported disability(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Self-reported pain intensity(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Health Related Quality of Life(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Global rating of change(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Satisfaction with health care(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Catastrophic Thinking(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Adverse events(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Health care accessibility(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Health care utilization(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Depressive symptoms(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- 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)
- Medications prescribed(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- Diagnostic imaging ordered(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- referrals to other health care providers made(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)
- notes made by primary care provider to employers or insurers(Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up)