Development and Feasibility Testing of an Advanced Practice Physiotherapy Role in Chronic Pain Management

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: APP-led model of care for chronic pain management

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:

1. 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.
2. To determine the feasibility of implementing the new APP model of care by monitoring the care provided and treatment fidelity.
3. 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 3N6
      • Queen's University
    • Kingston, Ontario, Canada, K7L 3N6
      • Kingston Health Sciences Center, Hotel Dieu site - Chronic Pain Clinic

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: APP-led model of care for chronic pain management; 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.

Behavioral: APP-led model of care for chronic pain management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant recruitment	Recruitment rate (participants/week) over 8 weeks.	Baseline to 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)	12 months
Duration of baseline survey completion	Mean time to complete the baseline survey	Baseline
Duration of follow-up survey completion	Mean time to complete follow-up surveys (includes surveys at 3, 6, 9, and 12 months)	12 months
Participant attrition	Attrition of participants expressed as a percentage lost to follow-up at 12 months.	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.	Baseline to 8 weeks
Treatment fidelity	Fidelity checklist for the APP intervention. Percentage of red flags screened for and percentage completion of all other assessment items.	Baseline to 8 weeks
Participant perspectives	Semi-structured interviews with participants involved in the study to explore acceptability of and satisfaction with the APP model of care.	1-2 months after visit with APP
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.	1-2 months after visit with APP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory - pain severity subscale	Numeric rating scale from 0 to 10, with higher scores indicating greater pain.	Baseline and 3, 6, 9, and 12 months follow-up
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.	Baseline and 3, 6, 9, and 12 months follow-up
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)	Baseline and 3, 6, 9, and 12 months follow-up
Pain Catastrophizing Scale	Score of 0 to 52 with higher scores indicating greater catastrophic thinking.	Baseline and 3, 6, 9, and 12 months follow-up
Tampa Scale of Kinesiophobia	17 items about pain-related fear. Higher scores (68 highest possible) suggesting worse pain-related fear.	Baseline and 3, 6, 9, and 12 months follow-up
Pain Self-Efficacy Questionnaire	Score of 0 to 60, with higher scores suggesting higher confidence in dealing with pain.	Baseline and 3, 6, 9, and 12 months follow-up
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.	3, 6, 9, and 12 months follow-up
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.	3, 6, 9, and 12 months follow-up
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.	3, 6, 9, and 12 months follow-up
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	12 months
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.	12 months
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.	12 months
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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline measures	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.	Baseline
Comorbidities	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.	Baseline

Collaborators and Investigators

• Sponsor: Jordan Miller, PT, PhD
• Collaborators: University Hospitals Kingston Foundation - Women's Giving Circle
• Investigators: Principal Investigator: Jordan Miller, PhD, Kingston Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Feasibility study
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: REH-782-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD with other researchers.

Drug and device information, study documents

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