Clinical trial NCT03320148: Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain
Official title: Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Recruitment of primary care teams
timeFrame: Baseline
measure: Recruitment of patient participants
timeFrame: Baseline to 14 weeks
measure: Assessment completion
timeFrame: Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
measure: Retention of patient participants
timeFrame: 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.
measure: Physiotherapist confidence in carrying out the interventions
timeFrame: Baseline
measure: Treatment fidelity
timeFrame: 6-week follow-up
Secondary outcomes:
measure: Self-reported disability
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Self-reported pain intensity
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Health Related Quality of Life
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Global rating of change
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Satisfaction with health care
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Catastrophic Thinking
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Depressive symptoms
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Adverse events
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Health care accessibility
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Health care accessibility
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Health care utilization
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Costs (piloted for a cost utility analysis in a future trial)
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Medications prescribed
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: Diagnostic imaging ordered
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: referrals to other health care providers made
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measure: notes made by primary care provider to employers or insurers
timeFrame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Jordan Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller J, Barber D, Donnelly C, French S, Green M, Hill J, MacDermid J, Marsh J, Norman K, Richardson J, Taljaard M, Wideman T, Cooper L, McPhee C. Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial. Trials. 2017 Nov 9;18(1):526. doi: 10.1186/s13063-017-2279-7.