Clinical trial NCT05336903: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Feasibility study
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: University Hospitals Kingston Foundation - Women's Giving Circle
First posted: 2022-04-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.

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.

Primary outcomes:
measure: Participant recruitment
timeFrame: Baseline to 8 weeks
measure: Assessment completion
timeFrame: 12 months
measure: Duration of baseline survey completion
timeFrame: Baseline
measure: Duration of follow-up survey completion
timeFrame: 12 months
measure: Participant attrition
timeFrame: 12 months
measure: Transfer of care
timeFrame: Baseline to 8 weeks
measure: Treatment fidelity
timeFrame: Baseline to 8 weeks
measure: Participant perspectives
timeFrame: 1-2 months after visit with APP
measure: Health care provider perspectives
timeFrame: 1-2 months after visit with APP
Secondary outcomes:
measure: Brief Pain Inventory - pain severity subscale
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Brief Pain Inventory - pain interference subscale
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Health-related quality of life
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Pain Catastrophizing Scale
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Tampa Scale of Kinesiophobia
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Pain Self-Efficacy Questionnaire
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Self-reported rating of change
timeFrame: 3, 6, 9, and 12 months follow-up
measure: Satisfaction with health care
timeFrame: 3, 6, 9, and 12 months follow-up
measure: Adverse events
timeFrame: 3, 6, 9, and 12 months follow-up
measure: Care provided
timeFrame: 12 months
measure: Health utilization
timeFrame: 12 months
measure: Health costs
timeFrame: 12 months
measure: Indirect costs
timeFrame: 12 months
Other outcomes:
measure: Baseline measures
timeFrame: Baseline
measure: Comorbidities
timeFrame: Baseline
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Center, Hotel Dieu site - Chronic Pain Clinic
state: Ontario
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Jordan Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: