Back to resultsDevelopment and Feasibility Testing of an Advanced Practice Physiotherapy Role in Chronic Pain Management
Primary Purpose
Chronic Pain
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
APP-led model of care for chronic pain management
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Pain focused on measuring Feasibility study
Eligibility Criteria
Inclusion Criteria:
- Chronic musculoskeletal pain (pain > 3 months in duration) (e.g., neck pain, thoracic pain, limb pain, low back pain) -OR-
- Chronic widespread pain (e.g., fibromyalgia, myofascial syndrome) -AND-
- 18 years of age or older -AND-
- Must be able to read, write, and speak English
Exclusion Criteria (as identified in referral package):
- Primary reason for referral stated as medication change or interventional pain management (e.g., injections, nerve block)
- Primary reason for referral is stated as headache or migraine.
- Reason for referral is chronic pelvic pain
- Referral includes information that patient has an untreated addiction, mental health disorder, or substance use disorder
- Referral indicates cancer-related pain
- Referral indicates medical "red flags" suggestive of non-musculoskeletal etiology of symptoms (e.g., unexplained symptoms, sudden weight loss, urinary retention, saddle anesthesia, evidence of upper motor neuron lesion, or fever)
- Referral states visceral pain or abdominal pain.
Sites / Locations
- Kingston Health Sciences Center, Hotel Dieu site - Chronic Pain Clinic
- Queen's University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
APP-led model of care for chronic pain management
Arm Description
The APP-led model of care involves integrating an APP as the first point of contact within an interprofessional chronic pain clinic setting. This is in contrast to the usual physician- or nurse practitioner-led model of care.
Outcomes
Primary Outcome Measures
Participant recruitment
Recruitment rate (participants/week) over 8 weeks.
Assessment completion
Proportion of all assessment items completed over the study duration (includes assessment items from baseline and 3, 6, 9, and 12 months follow-up)
Duration of baseline survey completion
Mean time to complete the baseline survey
Duration of follow-up survey completion
Mean time to complete follow-up surveys (includes surveys at 3, 6, 9, and 12 months)
Participant attrition
Attrition of participants expressed as a percentage lost to follow-up at 12 months.
Transfer of care
Percentage of cases where the APP can successfully fulfill the role without having to transfer care to a physician or nurse practitioner as the most responsible provider.
Treatment fidelity
Fidelity checklist for the APP intervention. Percentage of red flags screened for and percentage completion of all other assessment items.
Participant perspectives
Semi-structured interviews with participants involved in the study to explore acceptability of and satisfaction with the APP model of care.
Health care provider perspectives
Semi-structured interviews with health care providers involved in the study to explore acceptability of and satisfaction with the APP model of care.
Secondary Outcome Measures
Brief Pain Inventory - pain severity subscale
Numeric rating scale from 0 to 10, with higher scores indicating greater pain.
Brief Pain Inventory - pain interference subscale
Numeric rating scale from 0 to 10, with higher scores indicating greater pain interference with 7 elements of daily living.
Health-related quality of life
EuroQoL-5D-5L. This measure can be used in economic evaluations of health interventions. An index value is assigned and the EQ VAS is incorporated (0-100 scale, with higher scores representing better perceived health)
Pain Catastrophizing Scale
Score of 0 to 52 with higher scores indicating greater catastrophic thinking.
Tampa Scale of Kinesiophobia
17 items about pain-related fear. Higher scores (68 highest possible) suggesting worse pain-related fear.
Pain Self-Efficacy Questionnaire
Score of 0 to 60, with higher scores suggesting higher confidence in dealing with pain.
Self-reported rating of change
Global rating of change scale of -5 to +5, with negative values showing a worsening of functional abilities and positive values an improvement in functional abilities.
Satisfaction with health care
Satisfaction with care will be assessed using an 11-point scale (-5 to +5). Negative scores demonstrate dissatisfaction and positive score suggest satisfaction with care.
Adverse events
Survey to ask participants if they experienced any adverse events related to treatment received. This includes the type of adverse event experienced, how long the event lasted, how bothersome the event was (0-10 scale), and what the participant thought caused the event.
Care provided
To describe the care provided, the investigators will present counts of following information from the participant's electronic medical records:
prescriptions for medications
assessments completed
interventions delivered
requisitions for diagnostic images
referrals to other health care providers
visits to other health care providers within the chronic pain clinic
notes to employers or insurers
Health utilization
From self-reported surveys, the investigators will collect the following health utilization measure counts related to the participant's chronic pain: emergency department visits, overnight hospitalizations, diagnostic images received, surgical interventions and pain injections/procedures, primary care visits (including walk-in clinic visits), specialist visits, medications used, other health care provider appointments (physiotherapy, occupational therapy, chiropractic, massage therapy, social worker visits, psychology), and self-care assistance required. These measures will be captured at 3, 6, 9, and 12 months to obtain cumulative measures and reduce the risk of recall bias. Note: medications will also be captured at baseline.
Health costs
Using the health utilization measures, cumulative direct healthcare costs (total costs and by health utilization measure) will be calculated using the Ontario Ministry of Health and Long-term Care Schedule of Benefits for publicly funded services and the Ontario Drug Benefit formulary for medication costs. For private services (e.g. PT in the community), the mean cost for the services in Kingston will be used.
Indirect costs
Indirect costs will be restricted to loss of productivity using a human capital approach. A dollar value will be assigned to time lost from paid employment (part-time, full-time, and self-employment) based on the mean wage in Ontario, according to Statistics Canada. The minimum wage in Ontario will be used to assign a value to time lost from volunteering, caregiving, or homemaking activities.
Full Information
NCT ID
NCT05336903
First Posted
April 5, 2022
Last Updated
September 11, 2023
Sponsor
Queen's University
Collaborators
University Hospitals Kingston Foundation - Women's Giving Circle
1. Study Identification
Unique Protocol Identification Number
NCT05336903
Brief Title
Development and Feasibility Testing of an Advanced Practice Physiotherapy Role in Chronic Pain Management
Official Title
Development and Feasibility Testing of an Advanced Practice Physiotherapy Role in Chronic Pain Management
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
University Hospitals Kingston Foundation - Women's Giving Circle
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current study is intended to evaluate the feasibility of conducting a future trial to evaluate the effects of implementing an advanced practice physiotherapist (APP) role within a chronic pain clinic setting.
Detailed Description
This line of research ultimately seeks to assess the impact of integrating an APP as the first point of contact within interprofessional chronic pain clinics on patient health outcomes, care provided to patients, chronic pain clinic flow, and cost-utility in comparison to usual physician or nurse practitioner-led care.
The primary objectives of the feasibility study are:
To determine the feasibility of implementing the trial methods by evaluating participant recruitment rates, retention, and assessment completion at each of four follow-up time-points over a 12-month period.
To determine the feasibility of implementing the new APP model of care by monitoring the care provided and treatment fidelity.
To explore the perspectives of participants and health care providers related to the acceptability of the APP role; barriers, facilitators, and strategies for refining implementation; and perceived impact on clinic processes and outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Feasibility study
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single-arm feasibility study at the one chronic pain clinic in Kingston, Ontario, Canada. The intervention is the integration of an APP as the first point of contact in this interprofessional setting.
Masking
None (Open Label)
Masking Description
Participants will be invited to participate in the study with an understanding that they will be assigned to either a model of care in which they see the physician or nurse practitioner first or a model of care in which they see a physiotherapist first, even though this is a single arm feasibility study and all participants will be assigned to the APP model of care. This partial masking at the time of consent and initial assessment was determined to be important to provide accurate estimates of feasibility (e.g. consent rate, percentage of consenting participants who see the physiotherapist first who also request to see the physician or nurse practitioner). Due to the nature of the intervention, participants and healthcare providers will not be blinded to the intervention received in this or the fully powered trial. Since the primary outcome measures are self-report measures (ie. the participant is the assessor), the outcome assessor is similarly not planned to be blinded.
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
APP-led model of care for chronic pain management
Arm Type
Experimental
Arm Description
The APP-led model of care involves integrating an APP as the first point of contact within an interprofessional chronic pain clinic setting. This is in contrast to the usual physician- or nurse practitioner-led model of care.
Intervention Type
Behavioral
Intervention Name(s)
APP-led model of care for chronic pain management
Intervention Description
The APP will provide an assessment using a biopsychosocial approach. The assessment will include:
taking a comprehensive history
screening for pathologies contributing to the participant's chronic pain
a physical assessment
screening for comorbid health conditions, using the appropriate screening tools, that require specific care (e.g., depression, addiction, post-traumatic stress)
identifying psychosocial risk factors associated with pain and disability
evaluating pain severity and interference
The APP will make recommendations to the participant and the chronic pain clinic health care team based on findings from the comprehensive assessment. These recommendations include, but are not limited to, the need for urgent or emergent referrals, medication management, referral and integration of other health care providers, the need for interventional procedures, or group-based treatment options.
Primary Outcome Measure Information:
Title
Participant recruitment
Description
Recruitment rate (participants/week) over 8 weeks.
Time Frame
Baseline to 8 weeks
Title
Assessment completion
Description
Proportion of all assessment items completed over the study duration (includes assessment items from baseline and 3, 6, 9, and 12 months follow-up)
Time Frame
12 months
Title
Duration of baseline survey completion
Description
Mean time to complete the baseline survey
Time Frame
Baseline
Title
Duration of follow-up survey completion
Description
Mean time to complete follow-up surveys (includes surveys at 3, 6, 9, and 12 months)
Time Frame
12 months
Title
Participant attrition
Description
Attrition of participants expressed as a percentage lost to follow-up at 12 months.
Time Frame
12 months
Title
Transfer of care
Description
Percentage of cases where the APP can successfully fulfill the role without having to transfer care to a physician or nurse practitioner as the most responsible provider.
Time Frame
Baseline to 8 weeks
Title
Treatment fidelity
Description
Fidelity checklist for the APP intervention. Percentage of red flags screened for and percentage completion of all other assessment items.
Time Frame
Baseline to 8 weeks
Title
Participant perspectives
Description
Semi-structured interviews with participants involved in the study to explore acceptability of and satisfaction with the APP model of care.
Time Frame
1-2 months after visit with APP
Title
Health care provider perspectives
Description
Semi-structured interviews with health care providers involved in the study to explore acceptability of and satisfaction with the APP model of care.
Time Frame
1-2 months after visit with APP
Secondary Outcome Measure Information:
Title
Brief Pain Inventory - pain severity subscale
Description
Numeric rating scale from 0 to 10, with higher scores indicating greater pain.
Time Frame
Baseline and 3, 6, 9, and 12 months follow-up
Title
Brief Pain Inventory - pain interference subscale
Description
Numeric rating scale from 0 to 10, with higher scores indicating greater pain interference with 7 elements of daily living.
Time Frame
Baseline and 3, 6, 9, and 12 months follow-up
Title
Health-related quality of life
Description
EuroQoL-5D-5L. This measure can be used in economic evaluations of health interventions. An index value is assigned and the EQ VAS is incorporated (0-100 scale, with higher scores representing better perceived health)
Time Frame
Baseline and 3, 6, 9, and 12 months follow-up
Title
Pain Catastrophizing Scale
Description
Score of 0 to 52 with higher scores indicating greater catastrophic thinking.
Time Frame
Baseline and 3, 6, 9, and 12 months follow-up
Title
Tampa Scale of Kinesiophobia
Description
17 items about pain-related fear. Higher scores (68 highest possible) suggesting worse pain-related fear.
Time Frame
Baseline and 3, 6, 9, and 12 months follow-up
Title
Pain Self-Efficacy Questionnaire
Description
Score of 0 to 60, with higher scores suggesting higher confidence in dealing with pain.
Time Frame
Baseline and 3, 6, 9, and 12 months follow-up
Title
Self-reported rating of change
Description
Global rating of change scale of -5 to +5, with negative values showing a worsening of functional abilities and positive values an improvement in functional abilities.
Time Frame
3, 6, 9, and 12 months follow-up
Title
Satisfaction with health care
Description
Satisfaction with care will be assessed using an 11-point scale (-5 to +5). Negative scores demonstrate dissatisfaction and positive score suggest satisfaction with care.
Time Frame
3, 6, 9, and 12 months follow-up
Title
Adverse events
Description
Survey to ask participants if they experienced any adverse events related to treatment received. This includes the type of adverse event experienced, how long the event lasted, how bothersome the event was (0-10 scale), and what the participant thought caused the event.
Time Frame
3, 6, 9, and 12 months follow-up
Title
Care provided
Description
To describe the care provided, the investigators will present counts of following information from the participant's electronic medical records:
prescriptions for medications
assessments completed
interventions delivered
requisitions for diagnostic images
referrals to other health care providers
visits to other health care providers within the chronic pain clinic
notes to employers or insurers
Time Frame
12 months
Title
Health utilization
Description
From self-reported surveys, the investigators will collect the following health utilization measure counts related to the participant's chronic pain: emergency department visits, overnight hospitalizations, diagnostic images received, surgical interventions and pain injections/procedures, primary care visits (including walk-in clinic visits), specialist visits, medications used, other health care provider appointments (physiotherapy, occupational therapy, chiropractic, massage therapy, social worker visits, psychology), and self-care assistance required. These measures will be captured at 3, 6, 9, and 12 months to obtain cumulative measures and reduce the risk of recall bias. Note: medications will also be captured at baseline.
Time Frame
12 months
Title
Health costs
Description
Using the health utilization measures, cumulative direct healthcare costs (total costs and by health utilization measure) will be calculated using the Ontario Ministry of Health and Long-term Care Schedule of Benefits for publicly funded services and the Ontario Drug Benefit formulary for medication costs. For private services (e.g. PT in the community), the mean cost for the services in Kingston will be used.
Time Frame
12 months
Title
Indirect costs
Description
Indirect costs will be restricted to loss of productivity using a human capital approach. A dollar value will be assigned to time lost from paid employment (part-time, full-time, and self-employment) based on the mean wage in Ontario, according to Statistics Canada. The minimum wage in Ontario will be used to assign a value to time lost from volunteering, caregiving, or homemaking activities.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Baseline measures
Description
To describe the study population, the investigators will capture the following through the survey: age, gender, sex, education, identification as a member of a racialized group, identification as indigenous (First Nations, Inuit, Métis), duration and location of pain, current medications, work status, and annual household income.
Time Frame
Baseline
Title
Comorbidities
Description
Self-Administered Comorbidity Questionnaire. Participants select relevant comorbidities from a list of specific problems (with three optional, open-ended conditions), whether they receive treatment for the condition, and whether the problem limits their activities.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic musculoskeletal pain (pain > 3 months in duration) (e.g., neck pain, thoracic pain, limb pain, low back pain) -OR-
Chronic widespread pain (e.g., fibromyalgia, myofascial syndrome) -AND-
18 years of age or older -AND-
Must be able to read, write, and speak English
Exclusion Criteria (as identified in referral package):
Primary reason for referral stated as medication change or interventional pain management (e.g., injections, nerve block)
Primary reason for referral is stated as headache or migraine.
Reason for referral is chronic pelvic pain
Referral includes information that patient has an untreated addiction, mental health disorder, or substance use disorder
Referral indicates cancer-related pain
Referral indicates medical "red flags" suggestive of non-musculoskeletal etiology of symptoms (e.g., unexplained symptoms, sudden weight loss, urinary retention, saddle anesthesia, evidence of upper motor neuron lesion, or fever)
Referral states visceral pain or abdominal pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Miller, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston Health Sciences Center, Hotel Dieu site - Chronic Pain Clinic
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD with other researchers.
Learn more about this trial
Development and Feasibility Testing of an Advanced Practice Physiotherapy Role in Chronic Pain Management
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