Clinical trial NCT06681142: Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis
Official title: Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
Physiotherapy
Pharmacy
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 125
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 knee surgery
* history of acute knee injury (6 months)
* unable or unwilling to attend physiotherapy
* previous physician diagnoses of inflammatory arthritis or fibromyalgia
* unable to speak/ read English

Primary outcomes:
measure: Disease specific self-report measure for OA
timeFrame: Baseline, Post Intervention (3 & 6 month after baseline)
Secondary outcomes:
measure: Patient Activation Measure (PAM)
timeFrame: Baseline, Post Intervention (3 & 6 month after baseline)
Other outcomes:
Locations:
Study officials:
affiliation: University of Alberta
name: Ross Tsuyuki
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Jill Hall
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Allyson Jones
role: PRINCIPAL_INVESTIGATOR
References: