Back PainNCT03320148
Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain
A study testing Physiotherapist-led primary care model for back pain in people with Back Pain, run by Queen's University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- Physiotherapist-led primary care model for back pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2017to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who do not consent to participation
- Patients who report being unable to understand, read, and write English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Back Pain
- Being tested
- Physiotherapist-led primary care model for back pain, Usual care
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist-led primary care model for back painBehavioural
- 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.
Usual careOther
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of primary care teams
Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
Measured: Baseline
Recruitment of patient participants
Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
Measured: Baseline to 14 weeks
Assessment completion
Percentage of all assessment items completed by participants completing each assessment
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6-week follow-up
Secondary outcomes (16)
Self-reported disability
measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Medications prescribed
Measured as a process outcome
Measured: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Diagnostic imaging ordered
Measured as a process outcome
Measured: 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
Measured: 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
Measured: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start20 Sep 2017
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jordan Miller, PT, PhD, Queen's University
- Investigators
- Jordan Miller, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320148
- Sponsor's protocol ID
- 6021536
- Status last verified
- Mar 2019
- First submitted
- 16 Oct 2017
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 29121989
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03320148
- Acronym / sponsor ID
- 6021536
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Physiotherapist-led primary care model for back pain | Experimental | Behavioral: Physiotherapist-led primary care model for back painThe 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. |
| Usual care | Active comparator | Other: Usual careThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who do not consent to participation
- Patients who report being unable to understand, read, and write English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapist-led primary care model for back pain1. 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. | Behavioural | Physiotherapist-led primary care model for back pain |
| Usual careThe physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada. | Other | Usual care |
Primary outcome
Recruitment of primary care teams
Time frame: Baseline
Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
Recruitment of patient participants
Time frame: Baseline to 14 weeks
Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
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
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
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.
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.
16 secondary outcomes
Self-reported disability
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Self-reported pain intensity
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health Related Quality of Life
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Global rating of change
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Satisfaction with health care
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Catastrophic Thinking
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Depressive symptoms
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Adverse events
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care accessibility
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care accessibility
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care utilization
Time frame: 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)
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Medications prescribed
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Diagnostic imaging ordered
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
referrals to other health care providers made
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Derived from this study: PubMed 29121989Miller 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Miller, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist-led primary care model for back pain in people with Back Pain, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment of primary care teams (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03320148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.