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Clinical Trials/NCT05336903
NCT05336903
Completed
N/A

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

Jordan Miller, PT, PhD2 sites in 1 country45 target enrollmentJune 24, 2022
ConditionsChronic Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Jordan Miller, PT, PhD
Enrollment
45
Locations
2
Primary Endpoint
Participant recruitment
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 24, 2022
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Jordan Miller, PT, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Jordan Miller, PT, PhD

Assistant Professor, School of Rehabilitation Therapy, Queen's University

Queen's University

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Participant recruitment

Time Frame: Baseline to 8 weeks

Recruitment rate (participants/week) over 8 weeks.

Assessment completion

Time Frame: 12 months

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

Time Frame: Baseline

Mean time to complete the baseline survey

Participant attrition

Time Frame: 12 months

Attrition of participants expressed as a percentage lost to follow-up at 12 months.

Transfer of care

Time Frame: Baseline to 8 weeks

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.

Duration of follow-up survey completion

Time Frame: 12 months

Mean time to complete follow-up surveys (includes surveys at 3, 6, 9, and 12 months)

Treatment fidelity

Time Frame: Baseline to 8 weeks

Fidelity checklist for the APP intervention. Percentage of red flags screened for and percentage completion of all other assessment items.

Participant perspectives

Time Frame: 1-2 months after visit with APP

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

Time Frame: 1-2 months after visit with APP

Semi-structured interviews with health care providers involved in the study to explore acceptability of and satisfaction with the APP model of care.

Secondary Outcomes

  • Pain Catastrophizing Scale(Baseline and 3, 6, 9, and 12 months follow-up)
  • Tampa Scale of Kinesiophobia(Baseline and 3, 6, 9, and 12 months follow-up)
  • Self-reported rating of change(3, 6, 9, and 12 months follow-up)
  • Brief Pain Inventory - pain severity subscale(Baseline and 3, 6, 9, and 12 months follow-up)
  • Brief Pain Inventory - pain interference subscale(Baseline and 3, 6, 9, and 12 months follow-up)
  • Health-related quality of life(Baseline and 3, 6, 9, and 12 months follow-up)
  • Pain Self-Efficacy Questionnaire(Baseline and 3, 6, 9, and 12 months follow-up)
  • Satisfaction with health care(3, 6, 9, and 12 months follow-up)
  • Adverse events(3, 6, 9, and 12 months follow-up)
  • Care provided(12 months)
  • Health utilization(12 months)
  • Health costs(12 months)
  • Indirect costs(12 months)

Study Sites (2)

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