None listed
Conditions
Brief summary
Knee osteoarthritis is a common condition that causes considerable disability, much of which accrues during early- and mid-stage disease when osteoarthritis affects employment, productivity, and socio-economic wellbeing of affected individuals and their families. Knee osteoarthritis affects hundreds of thousands of New Zealanders and costs billions of dollars each year. As the population ages and the prevalence of obesity, chronic diseases, and risk factors for chronic diseases rise, the number of people with knee osteoarthritis will rapidly increase. This risks crippling the population, the health care system, and the economy if the current model of care is not radically changed. The impact of osteoarthritis could be greatly reduced through relatively low-cost but high-value care that can be provided in the community. When these interventions are provided early, they can change the course of the disease and considerably reduce its impact on people and communities. This care is often not provided due to knee osteoarthritis being ignored or not being judged important and due to inaccurate clinician and consumer beliefs about osteoarthritis. For people living with the condition, this results in progressive pain and disability and increased need for invasive and expensive interventions like knee joint replacement surgery. People with knee pain due to osteoarthritis often visit community pharmacy. Prior research has shown that community pharmacists are able to identify people who have previously been diagnosed with knee osteoarthritis and also accurately diagnose osteoarthritis in people with previously-undiagnosed knee pain. People with knee osteoarthritis appreciate pharmacists taking an interest in their condition and providing information to support self-management. Pharmacists are willing and able to integrate this osteoarthritis education role into their regular pharmacy practice. This study will explore the impact on health outcomes and health costs when community pharmacists provide novel research-based health information to people with knee osteoarthritis, refer these people to effective and funded community-based care, and provide ongoing health support.
Interventions
NAME:
KneeCAPS (Knee Care for Arthritis Through Pharmacy Service)
MATERIALS:
Information booklet and supporting website (designed for this trial, described in Darlow et al. 2020 and 2022, published in Osteoarthritis and Cartilage Open).
PROCEDURES:
Information - Provision of information booklet and accompanying explanation from community pharmacist
Motivation: face to face discussion with pharmacist to address questions, reinforce key messages, exploring priorities, identify goals (and
NAME: KneeCAPS (Knee Care for Arthritis Through Pharmacy Service) MATERIALS: Information booklet and supporting website (designed for this trial, described in Darlow et al. 2020 and 2022, published in Osteoarthritis and Cartilage Open). PROCEDURES: Information - Provision of information booklet and accompanying explanation from community pharmacist Motivation: face to face discussion with pharmacist to address questions, reinforce key messages, exploring priorities, identify goals (and barriers to achieving these), and discuss health care opportunities and referral options that may assist with goal achievement. Ongoing support from pharmacist (2 to 3 interactions over 6 weeks). Behavioural skills - 1) Core-guideline recommended care (Bannuru et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis): physiotherapist supervised exercise programme delivered one-on-one (exercises to strengthen the buttock, thigh, and calf muscles, as well as functional mobility exercises, that utilise the full available range of joint movement individualised to the capacity and impairments of each participant and progressed over six, 30 minute sessions delivered over 12 weeks with gradually increasing duration between each session to promote self-management) or by group classes (based on the NEuroMuscular Exercise (NEMEX) programme with participants able to attend able to attend two exercise classes per week for 12 weeks); dietitian supervised individualised dietary change programme that aims to improve eating and drinking behaviours (up to 6 sessions over 12 weeks); pharmacist supervised medication review that aims to optimise the use of pain medications (single 30 minute session). 2) No cost or low cost (participant funded) guideline concordant care. Participants will be provided with a list of the resources available and these will be included in the pharmacist discussion of care options available. Participants will be able to access these at their discretion: a. Online exercise programme : https://mykneeexercise.org.au/ b. Online pain coping skills training: www.paintrainer.org and https://painhealth.csse.uwa.edu.au/pain-management/ c. Community exercise and activity groups d. Water-based exercise groups WHO: There are three categories of intervention provider: 1) Pharmacists: NZ Registered Pharmacists working in community practice. 2) Physiotherapists: NZ Registered Physiotherapists working in community practice. 3) Dietitians: NZ Registered Dietitians working in community practice. Training for all clinicians: All clinicians complete online eLearning modules about: 1) cultural safety (whakawahaungatanga, implicit bias, Maori models of health and working with Maori patients/whanau, health literacy, interprofessional practice); 2) empowering people with knee OA (information, explanatory models, and supporting health behaviour change); physical activity, exercise and knee OA; 4) nutrition, body size and knee OA. Following self-guided eLearning, clinicians will join a 90 minute Zoom training session. The session will have three sections: 1) Practising the process of whakawahaungatanga as means of learning about interprofessional peers. 2) Discussing key messages from eLearning modules. 3) Learning about how each discipline supports and engages with people who have knee osteoarthritis and developing methods of communication. Discipline specific training: Pharmacists: online training module related to performing pain medication reviews Physiotherapists: exercise prescription based on the PEAK program (developed by the Centre for Health, Exercise & Sports Medicine (CHESM) at the University of Melbourne) to enable the delivery of evidence-based structured land-based therapeutic exercise care face to face or via video-conferencing. Physiotherapists providing group exercise classes will be required to have completed the GLA:D training programme to deliver the NEMEX intervention. HOW: All care (except initial pharmacist discussion) can be provided face to face or via telehealth (depending on patient preference and clinician availability). All interventions delivered individually except for when participants choose group rather than one-on one exercise classes. WHERE: Community pharmacy, physiotherapy, and dietetic practices. WHEN AND HOW MUCH: Initial pharmacist explanation: One explanation of up to ten minutes Extended discussion: one discussion of up to 25 minutes duration. Medication review: up to 30 minutes. Follow-up support: two to three contacts of up to 5 minutes each. One-on-one physiotherapy: up to six, 30 minute sessions over 12 weeks. Group supervised exercise: up to two exercise classes per week for 12 weeks. Dietitian: one 60 minute consultation and up to five 30 minute consultations over 12 weeks. TAILORING: Extended discussions with the pharmacist will be personalised based on the questions, goals and priorities of the participant. Participants will choose which care options they will access during their extended discussion with the pharmacist. They can choose to access all or none of the options but must choose between one-on-one and group exercise classes. Participants may receive fewer than 6 physiotherapy or dietetic sessions at their own or the clinician’s discretion. ADHERENCE: Delivery of care: For each participant, we will explore: 1) Whether they had an extended pharmacist consultation 2) What care they were referred for 3) Whether they attended referred care 4) How many sessions they attended for each referred care option 5) Whether they accessed any of the online resources
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be eligible for the study if they meet the following criteria: 1) They are over 18 years of age; and 2) They have knee pain that is due to OA. Diagnosis of knee OA will occur in one of two ways: a) Self-reported (by participant) as diagnosed by a specified health professional (e.g. general practitioner ; or b) Fulfilled National Institute for Health and Care Excellence (NICE) knee OA diagnostic criteria assessed by questionnaire (as part of the recruitment visit). The NICE diagnostic criteria are: i. Are you 45 years of age or older? (required response: Yes) ii. Do you have knee pain when you use your knee? (such as with or after walking, stairs, squatting, running etc.) (required response: Yes) iii. Have you had an acute (sudden) knee injury in the last 6 months? (required response: No) iv. Do you have knee stiffness in the morning that takes longer than 30 minutes to ease? (required response: No) v. Is your knee hot and swollen or getting worse quickly? (required response: No) These criteria mean that: - if someone has been diagnosed with knee OA by a health professional, they do not need to meet the NICE requirement of being 45 years of age or older (i.e. a 25 year old who had been diagnosed with knee OA by a health professional is eligible). - If someone has not previously had their knee pain diagnosed as being due to OA by a health professional, they must meet NICE diagnostic criteria including that they are 45 years of age or older (i.e. a 35 year old with knee pain that has not been diagnosed as being due to OA by a health professional, will not be eligible).
Exclusion criteria
Consumer participants will not be eligible for the study if they: 1) have had a total or partial knee joint replacement or have an existing booking for knee joint replacement surgery in the next 12 months. 2) have had knee surgery (e.g. arthroscopy) or other knee procedures (e.g. joint injection) in the last 12 months or have an existing booking for knee surgery or other procedure in the next 12 months. 3) are unable to read and write in English. 4) live in the same household as someone who has already been recruited into the study (to prevent group contamination). 5) have taken part in the feasibility study. 6) have participated in a DHB funded Mobility Action Programme or ACC funded Escalated Care Programme for knee OA 7) have a psychotic disorder.
Outcome results
None listed