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

NCT03320148 | Completed

• 1 other identifier: 6021536
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (6)

• Recruitment of primary care teams

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

  Baseline

• Recruitment of patient participants

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

  Baseline to 14 weeks

• Assessment completion

  Percentage of all assessment items completed by participants completing each assessment

  Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.

• Retention of patient participants

  Attrition rate

  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.

• Physiotherapist confidence in carrying out the interventions

  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.

  Baseline

• Treatment fidelity

  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.

  6-week follow-up

Secondary Outcomes (16)

• 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

Study Arms (2)

Physiotherapist-led primary care model for back pain

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Physiotherapist-led primary care model for back pain 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.

Physiotherapist-led primary care model for back pain

Usual care OTHER

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

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who do not consent to participation
• Patients who report being unable to understand, read, and write English

Sponsors & Collaborators

• Queen's University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

• 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.

  PMID: 29121989 DERIVED

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Jordan Miller, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Rehabilitation Therapy

Model Details: 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

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 25, 2017
• Study Start: September 20, 2017
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)