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Trial registered on ANZCTR


Registration number
ACTRN12619001435178
Ethics application status
Approved
Date submitted
3/10/2019
Date registered
16/10/2019
Date last updated
3/05/2021
Date data sharing statement initially provided
16/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Involving medical companions in an explanation about switching to a biosimilar.
Scientific title
The influence of medical companions on a patient’s hypothetical decision to switch to a
biosimilar.
Secondary ID [1] 299164 0
None
Universal Trial Number (UTN)
U1111-1238-5280
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients taking biologic medications (e.g. adalimumab, etanercept, infliximab, rituximab, tocilizumab) for rheumatic diseases. 314240 0
Patients taking biologic medications (e.g. adalimumab, etanercept, infliximab, rituximab, tocilizumab) for dermatological diseases. 314243 0
Decision making 314842 0
Condition category
Condition code
Inflammatory and Immune System 312604 312604 0 0
Rheumatoid arthritis
Skin 312605 312605 0 0
Dermatological conditions
Public Health 313087 313087 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dyad

The intervention is an information-based video that is delivered to a) patients and their support person (intervention) or b) patients without their support person (control). The explanation begins with a brief preamble explaining that whilst biosimilars are used overseas, they are currently not funded for use in rheumatology and dermatology clinics in New Zealand. It is also emphasised that the scenario is hypothetical and participating will not impact current treatment. The video presents a number of risks and benefits of switching to a biosimilar. Dyads (patients and their support person) are also given some time (approximately 5-10 minutes) to discuss the hypothetical option of switching.

The intervention is based on a standardised script and delivered once. The video explanation takes approximately five minutes. Participants receive the intervention either in the clinic where they usually have their appointments with their rheumatologist or dermatologist, or in the university research centre.
Intervention code [1] 315452 0
Treatment: Other
Intervention code [2] 315767 0
Behaviour
Comparator / control treatment
Single Patient

The active control group will receive the same standardised video explanation on switching (described above). However, patients in this group will receive the explanation without their support person and will not have the option to discuss the switch.
Control group
Active

Outcomes
Primary outcome [1] 321266 0
Patients' willingness to switch from a biologic drug to a biosimilar assessed using a dichotomous scale (yes/no).
Timepoint [1] 321266 0
Immediately post-intervention
Secondary outcome [1] 374487 0
All participants will complete one 10cm visual analogue scale assessing their cognitive risk perception.
Timepoint [1] 374487 0
Immediately post-intervention
Secondary outcome [2] 374488 0
Decisional conflict will be measured using the Decisional Conflict Scale (O'Connor, 1995).
Timepoint [2] 374488 0
Immediately post-intervention
Secondary outcome [3] 374489 0
Perceptions towards biosimilars will be measured with four items on a 11 point scale (0 = not at all, 10 = extremely). The items are: How confident would you feel (or would you feel about the patient) taking the biosimilar? How confident are you that the biosimilar will be as effective as the current drug? How confident are you that the biosimilar will be as safe as the current drug? How confident are you that the biosimilar will have no additional side effects than the current drug?
Timepoint [3] 374489 0
Immediately post-intervention
Secondary outcome [4] 374490 0
Involvement in the treatment decision will be measured with two items on an 11 point likert scale (0 = not at all, 10 = extremely). These items are: How much were you involved in the final decision? How much was the patient (or companion) involved in the final decision?
Timepoint [4] 374490 0
Immediately post-intervention
Secondary outcome [5] 375495 0
Social support will be measured with the following two items with 5 response choices (strongly agree to strongly disagree): During the appointment (study session) did you receive emotional support from your companion? During the appointment (study session) did you receive practical support from your companion?
Timepoint [5] 375495 0
Immediately post-intervention
Secondary outcome [6] 375659 0
Decision satisfaction will be measured using the Satisfaction with Decision Instrument (Holmes-Rovner et al., 1996).
Timepoint [6] 375659 0
Immediately post-intervention.
Secondary outcome [7] 375669 0
All participants will complete one 10cm visual analogue scale assessing their affective risk perception.
Timepoint [7] 375669 0
Immediately post-intervention.
Secondary outcome [8] 375670 0
All participants will complete one item assessing their perceived risk of a bad outcome.
Timepoint [8] 375670 0
Immediately post-intervention.

Eligibility
Key inclusion criteria
Patients are eligible to participate if they:
- are attending an appointment with their rheumatologist/dermatologist at a clinic across the Auckland and Waitemata District Health Board,
- are 18 years of age or over,
- take a biologic medication (e.g., adalimumab, etanercept, infliximab, rituximab, tocilizumab),
- have a companion (support person) that is 18 years of age or over.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from this study if they:
- are unable to fill out the questionnaires,
- cannot understand, read or write English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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)
A simple randomisation strategy will be applied using a randomisation table created by computer software. Randomisation will be conducted by an individual independent of the study.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/11/2019
Actual
17/12/2019
Date of last participant enrolment
Anticipated
16/03/2020
Actual
29/10/2020
Date of last data collection
Anticipated
16/03/2020
Actual
24/11/2020
Sample size
Target
78
Accrual to date
Final
79
Recruitment outside Australia
Country [1] 21829 0
New Zealand
State/province [1] 21829 0
Auckland

Funding & Sponsors
Funding source category [1] 303705 0
University
Name [1] 303705 0
University of Auckland
Country [1] 303705 0
New Zealand
Primary sponsor type
Individual
Name
Professor Keith Petrie
Address
Faculty of Medical and Health Sciences
School of Medicine
Department of Psychological Medicine
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 303814 0
Individual
Name [1] 303814 0
Nicola Dalbeth
Address [1] 303814 0
Faculty of Medical and Health Sciences
School of Medicine
University of Auckland
Building 502
85 Park Road
Grafton, Auckland 1023
Country [1] 303814 0
New Zealand
Other collaborator category [1] 280934 0
Individual
Name [1] 280934 0
Urte Scholz
Address [1] 280934 0
University of Zurich
Binzmühlestrasse 14 / Box 14,
CH-8050 Zürich
Country [1] 280934 0
Switzerland
Other collaborator category [2] 280935 0
Individual
Name [2] 280935 0
Chiara Gasteiger
Address [2] 280935 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland

2 Park Rd
Grafton
Auckland 1023
New Zealand
Country [2] 280935 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304230 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 304230 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 304230 0
New Zealand
Date submitted for ethics approval [1] 304230 0
12/09/2019
Approval date [1] 304230 0
01/10/2019
Ethics approval number [1] 304230 0

Summary
Brief summary
The purpose of this study is to investigate the role of companions in medical decisions and explore how risk perceptions might differ for patients who are accompanied. It is hypothesised that accompanied patients will be more risk averse and less willing to switch to a biosimilar medicine compared to patients making the decision alone.

The study consists of a one-way between-subject design. Patients attending a routine rheumatology or dermatology consultation with their companion will be randomised to receive standardised information on switching either 1) with their medical companion or 2) individually. Findings may enable physicians to better accommodate accompanied patients and ensure patients make treatment decisions that they are satisfied and comfortable with. Appropriately involving companions in medical decisions may also help them to provide further support.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96214 0
Prof Keith Petrie
Address 96214 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
School of Medicine
University of Auckland
Auckland Hospital Support Building
Grafton, Auckland 1023
Country 96214 0
New Zealand
Phone 96214 0
+64 9 923 6564
Fax 96214 0
Email 96214 0
[email protected]
Contact person for public queries
Name 96215 0
Keith Petrie
Address 96215 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
School of Medicine
University of Auckland
Auckland Hospital Support Building
Grafton, Auckland 1023
Country 96215 0
New Zealand
Phone 96215 0
+64 9 923 6564
Fax 96215 0
Email 96215 0
[email protected]
Contact person for scientific queries
Name 96216 0
Keith Petrie
Address 96216 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
School of Medicine
University of Auckland
Auckland Hospital Support Building
Grafton, Auckland 1023
Country 96216 0
New Zealand
Phone 96216 0
+64 9 923 6564
Fax 96216 0
Email 96216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.