Task Shifting in the Care for Patients With Hand Osteoarthritis

Study Overview
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Brief Summary
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The main aim in this randomized controlled trial is to improve access to safe and effective care, professional practice and cost-effective utilisation of health care resources by testing if occupational therapist-led care is as effective and safe as rheumatologist-led care for people with hand osteoarthritis.

Detailed Description
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Hand osteoarthritis is one of the most prevalent musculoskeletal conditions in an adult population, and may have large influences on an individual's function, health related quality of life, and participation in the society. In the absence of disease-modifying interventions, occupational therapy, comprising information, hand exercises, assistive devices and orthoses/splints, is considered as core treatment. In Norway, people with hand osteoarthritis are increasingly referred to consultation by a rheumatologist in specialist health care. At the same time a shortage of rheumatologists nationwide is stressing the healthcare system's capacity, and rheumatologists time should therefore primarily be allocated to patients in which early diagnosis and medical treatment are essential. The World Health Organization recommend task-shifting as one method of strengthening and expanding the health workforce. Such models rely on other healthcare providers in expanded clinical roles, where physiotherapists, nurses or occupational therapists working in collaboration with physicians and other team members have their own patients for whom they provide health care services. In this randomized controlled trial, we will test if a new model, where patients referred to consultation in specialist health care receive their first consultation by an occupational therapy specialist, is as safe and effective as the traditional model, where they receive their first consultation by a rheumatologist.

Official Title
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Task Shifting in the Care for Patients With Hand Osteoarthritis: May the First Consultation in Specialist Health Care be Performed by an Occupational Therapy Specialist?

Conditions
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Osteoarthritis Both Hands

Intervention / Treatment
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* Behavioral: Rheumatologist-led care.
* Behavioral: Occupational therapist-led care.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hand osteoarthritis diagnosed by physician in primary care, referred for consultation in specialist health care, and ability to communicate in Norwegian. Exclusion Criteria: Exclusion criteria were cognitive or mental impairment, possible inflammatory rheumatic disease (SR>40 or CRP>20, or patient confirming having psoriasis during telephone screening).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this randomized controlled trial, participants will be allocated to receive their first consultation in specialist health care by either an occupational therapy specialist or a rheumatologist. The occupational therapist may thereafter refer the patient to a consultation with a rheumatologist if necessary, and vice versa.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients in the control group will receive their first consultation in specialist health care by a rheumatologist. Rheumatologist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, and, for some patients, Intra-articular injection of long-acting Corticosteroid. The rheumatologist may also refer participants to occupational therapy if needed. | Behavioral: Rheumatologist-led care.<br>* Rheumatologist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, and, for some patients, Intra-articular injection of long-acting Corticosteroid. The rheumatologist may also refer participants to occupational therapy if needed.<br>|
| Experimental: Intervention<br>Patients in the intervention group will receive their first consultation in specialist health care by an occupational therapy specialist. Occupational therapist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, teaching of hand exercises and ergonomic working methods, and, for some patients, provision assistive devices and orthoses/splints. The occupational therapist will refer patients to a short rheumatologist consultation if confirmation of diagnosis or intra-articular injections of long-acting Corticosteroid are needed. | Behavioral: Occupational therapist-led care.<br>* Occupational therapist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, teaching of hand exercises and ergonomic working methods, and, for some patients, provision assistive devices and orthoses/splints. The occupational therapist will refer patients to a short rheumatologist consultation if confirmation of diagnosis or intra-articular injections of long-acting Corticosteroid are needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment responders | Number of treatment responders will be calculated as number of OMERACT/OARSI-responders. This is a composite index that presents the results of changes after treatment in the three domains of pain, function and patient's global assessment as a single variable (responder yes/no). | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of painful finger joints | Joint count of number of painful finger joints at each hand | One year | 
| Hand pain measured on a numeric rating scale | Hand pain will be measured on a numeric rating scale | One year | 
| Hand stiffness measured on a numeric rating scale | Hand stiffness will be measured on a numeric rating scale | One year | 
| Disease activity measured on a numeric rating scale | Disease activity will be measured on a numeric rating scale | One year | 
| Physical function measured by the Functional Index for Hand OsteoArthritis | Physical function will be measured by the Functional Index for Hand OsteoArthritis | One year | 
| Activity performance measured by the Measure of Activity Performance of the Hand | Activity performance will be measured by the Measure of Activity Performance of the Hand | One year | 
| Grip strength measured by JAMAR dynamometer | Grip strength will be measured by JAMAR dynamometer | One year | 
| Health related quality of life measured by EQ5D | Health related quality of life will be measured by EQ5D | One year | 
| Satisfaction with care measured by PASS-Opp | Satisfaction with care will be measured by PASS-Opp | One year |