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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05336903
• Other study ID #: REH-782-20
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 24, 2022
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: September 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Center, Hotel Dieu site - Chronic Pain Clinic	Kingston	Ontario
Canada	Queen's University	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Jordan Miller, PT, PhD	University Hospitals Kingston Foundation - Women's Giving Circle

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Participant recruitment	Recruitment rate (participants/week) over 8 weeks.	Baseline to 8 weeks
Primary	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
Primary	Duration of baseline survey completion	Mean time to complete the baseline survey	Baseline
Primary	Duration of follow-up survey completion	Mean time to complete follow-up surveys (includes surveys at 3, 6, 9, and 12 months)	12 months
Primary	Participant attrition	Attrition of participants expressed as a percentage lost to follow-up at 12 months.	12 months
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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