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Trial registered on ANZCTR


Registration number
ACTRN12620000068965
Ethics application status
Approved
Date submitted
20/12/2019
Date registered
28/01/2020
Date last updated
28/01/2020
Date data sharing statement initially provided
28/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Care for Osteoarthritis through Pharmacy Education and Referral
Scientific title
The effect of education and support initiated through community pharmacy on health outcomes for people who have knee osteoarthritis: a feasibility study
Secondary ID [1] 300149 0
HRC 19/675
Universal Trial Number (UTN)
U1111-1245-7524
Trial acronym
f-COPER (feasibility of Care for Osteoarthritis through Pharmacy Education and Referral)
Linked study record
This record is the second phase of a feasibility study to prepare for a full clinical trial.

The first phase of the study is described in ACTRN12620000020987.

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 315688 0
Condition category
Condition code
Musculoskeletal 313971 313971 0 0
Osteoarthritis
Public Health 313972 313972 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: COPER booklet plus pharmacist explanation plus referral to an arthritis educator

The COPER booklet was specifically designed for this study. It contains information about osteoarthritis, explanation of common myths, and information about investigations, pain, other symptoms, optimising quality of life, movement and activity, diet and sleep, and seeking support. The COPER booklet integrates a biopsychosocial perspective and quotations from people who have knee osteoarthritis. A supporting website can be accessed using a link provided with the booklet. The website contains more detailed information, video content, links to research and other resources, and worksheets to aid development of an arthritis action plan.
Community pharmacists will be trained (through a 60 minute training session) to provide consumers explanations that support the information provided in the COPER booklet and to refer consumers to Arthritis New Zealand. The training session will be led by a Musculoskeletal Physiotherapy Specialist university researcher who led the development of the COPER booklet. The interactive training session will include explanation and discussion of the COPER booklet and supporting website and the underpinning research, discussion of 2018 The Royal Australian College of General Practitioners Osteoarthritis Guideline recommendations regarding medications and supplementation, referral processes to arthritis educators, and the expected content and focus of arthritis educator interactions with consumers referred. Pharmacists will be able to refer to the supporting website that contains video examples of consumer explanations about the COPER booklet (in addition to the information designed for consumers).
The pharmacist will provide a single face to face explanation (of approximately 5 to 15 minutes duration) to a consumer with knee osteoarthritis. This will orient the consumer to the booklet’s background, format and layout, briefly explain the content of the booklet, and answer any initial questions that the person has. The pharmacist will not be encouraged to recommend medications or supplementation as part of this explanation. The pharmacist will then provide the consumer a COPER booklet, and offer to refer the person to an arthritis educator employed by Arthritis New Zealand. The arthritis educator will telephone the consumer and answer questions; provide further explanation; identify impairments and priorities; develop individual goals; identify and discuss therapeutic options; and provide behaviour change support and coaching. It is anticipated the initial arthritis educator telephone call will take between 30 and 60 minutes. The arthritis educator will be able to contact the person multiple times as determined necessary by the person and educator. People who receive the COPER booklet and explanation will also be able to access the supporting website at their discretion for as long as they wish. Use of the booklet and website or adherence to the recommendations will not be monitored or assessed. Arthritis educator contact with consumers will be recorded (number of calls, duration of each call, content of calls, and consumer expressed interest in therapeutic options).
Each pharmacist participant will provide up to 4 consumer explanations (up to 36 explanations will be delivered by all pharmacists across the feasibility study).

A purposive selection of 12 consumers who receive COPER explanations will be invited to participate in a one-off semi-structured telephone-based qualitative interview of approximately 30 minutes duration. These interviews will discuss consumers’ perceptions of OA diagnosis in pharmacy, the explanation and booklet they received, the acceptability of receiving this information in a community pharmacy, and the arthritis educator support/reasons for not wanting to be contacted by an arthritis educator.
Intervention code [1] 316421 0
Rehabilitation
Intervention code [2] 316422 0
Lifestyle
Intervention code [3] 316423 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322379 0
Pharmacist perceptions measured through pharmacist focus groups. These audio-recorded semi-structured facilitated group interviews will last approximately 60 minutes.
Timepoint [1] 322379 0
Focus groups will be convened after pharmacists have completed providing the COPER explanations to consumers with knee osteoarthritis
Primary outcome [2] 322380 0
Consumer perceptions measured through telephone qualitative interviews. These audio-recorded, semi-structured interviews with open-ended questions will last approximately 30 minutes.
Timepoint [2] 322380 0
> 2 weeks post receiving the COPER explanation
Secondary outcome [1] 378268 0
The proportion of people who receive the COPER explanation from a pharmacist who consent to Arthritis NZ contact. This will be recorded by the pharmacist on a standardised data collection sheet.
Timepoint [1] 378268 0
Four weeks post COPER explanation
Secondary outcome [2] 378269 0
The elements of the proposed model of service delivery that the consumer would like to receive. These elements are: one-on-one physiotherapy-supervised strengthening programme (up to 12 sessions); group physiotherapy-supervised strengthening programme (up to 12 sessions); community based exercise/activity groups; water-based exercise; one-on-one dietetic sessions (up to 6 sessions); online pain coping skills training; online support group/community; primary care consultation; social and employment services.

This will be measured by the arthritis educator completing a checklist of all of the proposed options and ticking those the person would like to receive
Timepoint [2] 378269 0
Four weeks post COPER explanation

Eligibility
Key inclusion criteria
Pharmacists:
• New Zealand registered pharmacist
• Working in Canterbury
• Working in a community pharmacy that has agreed to participate in the study

Consumers:
• They are over 18 years of age
• They have knee pain that has been:
o diagnosed by a health professional as OA, or
o diagnosed within the pharmacy as OA as part of the recruitment visit, using
the NICE (National Institute for Health and Care Excellence) diagnostic criteria
• They have attended a pharmacy participating in the study and received an OA explanation and COPER booklet from a pharmacist who had attended the training session
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pharmacist participants will be excluded if they:
• do not participate in study training sessions.

Consumer participants will not be eligible for the study if they:
• have had a joint replacement in either knee at any time.
• have had knee surgery (other than joint replacement) in the last 12 months.
• are unable to read and write in English.
• have taken part in Phase I of this feasibility study ('The effect of health information distributed to people with knee osteoarthritis through community pharmacies on health perceptions, attitudes, and knowledge: a feasibility study' (ACTRN12620000020987))

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size:

12 pharmacists will be recruited to take part in qualitative focus groups.

12 consumers who receive COPER explanations will be recruited to take part in qualitative telephone interviews

Qualitative data:

Qualitative data (pharmacist focus groups and consumer telephone interviews) will be transcribed verbatim, managed using N-Vivo software. Data will be analysed using Thematic Analysis. Pharmacist focus group and patient transcripts will be analysed separately. Data will be analysed iteratively to enable themes that emerge in early interviews can be explored in subsequent interviews.

Quantitative data:

Agreement to be referred to Arthritis New Zealand, and component of the model of care selected will be analysed descriptively

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22197 0
New Zealand
State/province [1] 22197 0
Canterbury

Funding & Sponsors
Funding source category [1] 304585 0
Government body
Name [1] 304585 0
Health Research Council of New Zealand
Address [1] 304585 0
110 Stanley Street
Auckland 1010
New Zealand
Country [1] 304585 0
New Zealand
Primary sponsor type
Individual
Name
Dr Ben Darlow
Address
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 304876 0
None
Name [1] 304876 0
Address [1] 304876 0
Country [1] 304876 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305011 0
Health and Disability Ethics Committees
Ethics committee address [1] 305011 0
Ministry of Health
133 Molesworth St
Wellington 6011
New Zealand
Ethics committee country [1] 305011 0
New Zealand
Date submitted for ethics approval [1] 305011 0
03/10/2019
Approval date [1] 305011 0
19/12/2019
Ethics approval number [1] 305011 0
19/NTA/146

Summary
Brief summary
We have developed a new information booklet for people who have knee osteoarthritis and a model of providing care that includes an explanation from a community pharmacist and subsequent referral to co-ordinated care. This study will test the feasibility of conducting a full-scale clinical trial in a community pharmacy setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98958 0
Dr Ben Darlow
Address 98958 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein St
Newtown
Wellington 6021
New Zealand
Country 98958 0
New Zealand
Phone 98958 0
+6449186051
Fax 98958 0
Email 98958 0
ben.darlow@otago.ac.nz
Contact person for public queries
Name 98959 0
Dr Ben Darlow
Address 98959 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein St
Newtown
Wellington 6021
New Zealand
Country 98959 0
New Zealand
Phone 98959 0
+6449186051
Fax 98959 0
Email 98959 0
ben.darlow@otago.ac.nz
Contact person for scientific queries
Name 98960 0
Dr Ben Darlow
Address 98960 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein St
Newtown
Wellington 6021
New Zealand
Country 98960 0
New Zealand
Phone 98960 0
+6449186051
Fax 98960 0
Email 98960 0
ben.darlow@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a feasibility study and data will not be appropriate for sharing. We plan to share IPD from the full RCT that the feasibility study will inform.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6257 0
Ethical approval
Citation [1] 6257 0
Link [1] 6257 0
Email [1] 6257 0
ben.darlow@otago.ac.nz
Other [1] 6257 0
Attachment [1] 6257 0
Summary results
No Results