Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis

Overview

Osteoarthritis (OA) is a slowly progressive chronic condition that is associated with aging and is characterized as joint pain. Individuals with early-stage OA usually do not seek medical attention. If and when they do, patients more often present to a pharmacy for over-the-counter medications. The investigators want to leverage community pharmacists' accessibility and scope of practice to best support patients with early knee OA. Given there are no disease-modifying treatments for OA, treatment guidelines center on patient education, self-management, and exercise, with medications playing a supporting role. Self-management is an effective strategy that provides a solid foundation for managing this progressive chronic condition and health care professionals like physiotherapists and pharmacists can help with the development and application of these skills.

Detailed description

Pharmacists will identify patients with knee pain using two recruitment strategies: (1) Posters placed near the dispensary and 'shelf talkers' placed near the over-the-counter non- steroidal anti-inflammatory drugs, acetaminophen, and natural health products (e.g. glucosamine, collagen) will recommend patients with knee pain talk to their pharmacist and (2) Patients receiving care by a pharmacist for other conditions that have similar risk factors as OA will be asked about symptomatic knee OA (e.g. obesity).

The inclusion criteria is patients 50 years of age or older who have been regularly experiencing pain, aching, or stiffness in and/or around the knee for at least 1 month. The exclusion criteria is patients with prior knee surgery, history of acute knee injury (6 months), unable or unwilling to attend physiotherapy, previous physician diagnoses of inflammatory arthritis or fibromyalgia, and unable to speak/ read English.

For those patients with probable symptomatic knee OA, the study will be explained and upon agreement, written consent will be secured. Following enrollment, the pharmacist will ask participants to complete the baseline assessments (in pharmacy or online):

* Knee injury and OA Outcome Score (KOOS) -Reason for visiting the pharmacy * Socio-demographics (DOB, sex/gender, education, marital status, employment) -Past medical history (chronic conditions, current medications, height/weight, other joint involvement) -Previous medications/injections trialed for knee pain -Lifestyle activities (smoking, alcohol use, walking tolerance and any assistive walking devices) -Co-interventions (eg. chiropractor, joint injections, naturopath) -Self-management (Patient Activation Measure) The pharmacist will also answer questions that participants may have regarding services and medications.

Participants will be randomized to either the control arm which is usual care or the intervention arm which includes a referral to physiotherapy and a comprehensive medication review. Randomization will occur in variable computer-generated blocks of 4-8 participants. Following the enrolment, the pharmacist will receive a code that randomizes the patients into either the treatment group (comprehensive pharmacist assessment, pharmacologic recommendations, and education with referral to physiotherapy) or usual care (brief assessment and recommendation by the pharmacist, education information brochure).

If participants have a family physician, the pharmacist will provide a notice that the patient likely has knee OA and is enrolled in this study. The name of the pharmacist and physiotherapist will be provided.

Interventions

• Other Pharmacy-Physiotherapy Intervention
  Pharmacists will provide comprehensive 1:1 patient care, including a complete patient assessment and medication review, provide specific drug therapy recommendation(s) using shared decision making (SDM), and provide patient education, including further written materials. Participants will be offered either individual or group physiotherapy sessions at the a private clinic.

Primary outcome measures

• Disease specific self-report measure for OA [Time frame: Baseline, Post Intervention (3 & 6 month after baseline)]

Secondary outcome measures (1)

• Patient Activation Measure (PAM) [Time frame: Baseline, Post Intervention (3 & 6 month after baseline)]

Eligibility criteria

Inclusion criteria

• regularly experiencing pain, aching, or stiffness in and/or around the knee for at least 1 month
• complete the screening PhIT-OA questionnaire

Exclusion criteria

• Prior total knee replacement or on the waitlist to have your knee replaced
• Knee surgery within the previous 4 months
• History of acute injury to knee within previous 6 months
• Unable to speak and read English
• Unwilling or unable to visit a physiotherapist at a community physiotherapy clinic (specifically the dates and times of the partnering physiotherapy clinic)
• Previous physician-diagnosed inflammatory arthritis (including this list): Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Lupus, Gout
• Physician diagnosed fibromyalgia
• A sudden, severely painful, hot, swollen joint at any time in the past
• History of the following medications: csDMARD or bDMARD or tsDMARD, Immunosuppressive, Allopurinol or febuxostat, Colchicine
• Received a knee joint injection in the past 3 months or have one scheduled in the next 3 months
• Has completed the GLA:D Hip and Knee program at all in the past

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Double blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• Mint Health & Drugs Sherwood Park — Sherwood Park

Identifiers

NCT: NCT06681142 · Pro00145908

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗