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

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320148
• Other study ID #: 6021536
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: January 15, 2019

Study information

• Verified date: March 2019
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Intervention

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.

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

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment of primary care teams	Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate	Baseline
Primary	Recruitment of patient participants	Recruitment rate (participants/week) or total number of participants recruited in 14 weeks	Baseline to 14 weeks
Primary	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.
Primary	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.
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Medications prescribed	Measured as a process outcome	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Secondary	Diagnostic imaging ordered	Measured as a process outcome	Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Secondary	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
Secondary	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