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Completed

NCT Number: NCT03320148

Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain

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.

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Key information

Conditions

Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapist-led primary care model for back pain

Behavioral
  • Assessment and screening: taking a history; screening for red flags, comorbidities, and risk factors of ongoing pain and disability; physical examination
  • Brief individualized intervention at the first visit: effective communication, cognitive reassurance, a few exercises, and advice/strategies to stay active.
  • 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).
  • 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.

Usual Care

Other

The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Primary outcomes

  1. Recruitment of primary care teams

    Time frame: Baseline

    Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate

  2. Recruitment of patient participants

    Time frame: Baseline to 14 weeks

    Recruitment rate (participants/week) or total number of participants recruited in 14 weeks

  3. 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

  4. 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

  5. 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.

  6. 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

  1. Self-reported disability

    Time frame: 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)

  2. Self-reported pain intensity

    Time frame: 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)

  3. Health Related Quality of Life

    Time frame: 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)

  4. Global rating of change

    Time frame: 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)

  5. Satisfaction with health care

    Time frame: 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)

  6. Catastrophic Thinking

    Time frame: 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)

  7. Depressive symptoms

    Time frame: 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)

  8. Adverse events

    Time frame: 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.

  9. Health care accessibility

    Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Percentage of patients receiving care within 48 hours.

  10. Health care accessibility

    Time frame: 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.

  11. Health care utilization

    Time frame: 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

  12. 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

    Includes all health care costs plus societal costs using a human capital approach for loss of productivity

  13. Medications prescribed

    Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Measured as a process outcome

  14. Diagnostic imaging ordered

    Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Measured as a process outcome

  15. referrals to other health care providers made

    Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Measured as a process outcome

  16. 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

    Measured as a process outcome

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2017
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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