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

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ClinicalTrials.gov Identifier: NCT03320148
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jordan Miller, PT, PhD, 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.

Condition or disease Intervention/treatment Phase
Back Pain Behavioral: Physiotherapist-led primary care model for back pain Other: Usual care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
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.
Primary Purpose: Health Services Research
Official Title: Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: 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.
Behavioral: Physiotherapist-led primary care model for back pain
  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.

Active Comparator: 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.
Other: Usual care
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320148


Contacts
Contact: Jordan Miller, PhD 905-872-9938 jordan.miller@queensu.ca
Contact: Kevin Varette, MSc 613-888-5943 varettek@queensu.ca

Locations
Canada, Ontario
Queen's University Recruiting
Kingston, Ontario, Canada, K7L 3N6
Contact: Jordan Miller, PhD    905-872-9938    jordan.miller@queensu.ca   
Contact: Kevin Varette, MSc    613-888-5943    varettek@queensu.ca   
Sponsors and Collaborators
Queen's University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Jordan Miller, PhD Queen's University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jordan Miller, PT, PhD, Assistant Professor, School of Rehabilitation Therapy, Queen's University
ClinicalTrials.gov Identifier: NCT03320148     History of Changes
Other Study ID Numbers: 6021536
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data from this pilot study. This data will be used to inform the protocol for a fully powered cluster randomized trial.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms