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

NCT ID: NCT03320148

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2019-01-15

Brief Summary

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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

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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.

Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Physiotherapist-led primary care model for back pain

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

Usual care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Jordan Miller, PT, PhD

Assistant Professor, School of Rehabilitation Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jordan Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Queen's University

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 29121989 (View on PubMed)

Other Identifiers

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6021536

Identifier Type: -

Identifier Source: org_study_id

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