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

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Behavioral: Physiotherapist-led primary care model for back pain; Other: Usual care

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
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 3N6
      • Queen's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported disability	measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Self-reported pain intensity	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)	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health Related Quality of Life	measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Global rating of change	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)	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Satisfaction with health care	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)	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Catastrophic Thinking	measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Depressive symptoms	measured using the 9-item Patient Health Questionnaire (PHQ-9) (0 to 27 with greater scores indicating increased depressive symptoms)	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Adverse events	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.	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care accessibility	Percentage of patients receiving care within 48 hours.	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care accessibility	Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care utilization	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	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Costs (piloted for a cost utility analysis in a future trial)	Includes all health care costs plus societal costs using a human capital approach for loss of productivity	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Medications prescribed	Measured as a process outcome	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Diagnostic imaging ordered	Measured as a process outcome	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
referrals to other health care providers made	Measured as a process outcome	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
notes made by primary care provider to employers or insurers	Measured as a process outcome	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Jordan Miller, PhD, Queen's University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 6021536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No