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Trial registered on ANZCTR


Registration number
ACTRN12618000009213
Ethics application status
Approved
Date submitted
7/12/2017
Date registered
10/01/2018
Date last updated
21/02/2020
Date data sharing statement initially provided
21/02/2020
Date results provided
21/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of explaining biosimilars in different ways on patients' willingness to switch from a biologic drug to a biosimilar
Scientific title
Starting the conversation: The effect of positive and negative framing and use of an analogy on the willingness to switch to a biosimilar in patients who are prescribed with a biosimilar
Secondary ID [1] 293486 0
Nil known
Universal Trial Number (UTN)
U1111-1204-5518
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with any kind of health condition who take a biologic medication (e.g., Humira, Enbrel, infliximab, rituximab, tocilizum) 305674 0
Rheumatoid arthritis 305902 0
Dermatological conditions 305903 0
Condition category
Condition code
Inflammatory and Immune System 304894 304894 0 0
Rheumatoid arthritis
Skin 304895 304895 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Positive-framing and analogy explanation of biosimilars

The current intervention is information-based and explains biosimilars to patients in a positively framed way and by using an analogy. The intervention starts with a preamble explaining that biosimilars are increasingly used in rheumatology/dermatology clinics but currently not in New Zealand. It is emphasized that the scenario which is described in the following is hypothetical and not related to the patient's current medicine. The main goal of the study - examining patients reactions to different ways of explaining a switch from a biologic to a biosimilar drug - is described. The positively framed explanation of the biosimilar follows and focuses on similarities between biosimilars and biologic drugs. Additionally patients are provided with an analogy which compares the way how biosimilars are manufactured with the concept of baking bread and the use of different brands of yeast that may be more or less expensive.

The intervention is provided by a candidate for a Masters degree in Health Psychology. The intervention is based on a standardized script and will be delivered once and individually in a face-to-face contact. It takes 5 minutes. Patients receive the intervention either in the clinic where they usually have their appointments with their rheumatologist/dermatologist or in a university research center.
Intervention code [1] 299726 0
Treatment: Other
Comparator / control treatment
The three control interventions are information-based, are provided by the same person and in the same places and take approximately the same time as the experimental intervention (approximately 5 minutes) described above.

Positive-framing only explanation of biosimilars
This intervention includes the positive framing as described above but without using an analogy to describe the process of manufacturing of a biosimilar.

Negative-framing and analogy explanation of biosimilars
In contrast to the positive framing, the negatively framed explanation of biosimilar focuses on differences between a biosimilar and a biologic drug. It emphasizes that biosimilars cannot be guaranteed to have a similar effect as a biologic. The analogy is the same as described above.

Negative-framing only explanation of biosimilars
This intervention includes the negative framing as described above but without using an analogy to describe the process of manufacturing of a biosimilar.
Control group
Active

Outcomes
Primary outcome [1] 304098 0
patients' willingness to switch from a biologic drug to a biosimilar assessed using a dichotomous scale (yes/no)
Timepoint [1] 304098 0
at the end of the intervention
Secondary outcome [1] 340965 0
patients' perceived efficacy of their current biologic drug assessed using a 11-point numeric rating scale (NRS)
Timepoint [1] 340965 0
at the end of the intervention
Secondary outcome [2] 340966 0
patients' expected efficacy of a biosimilar assessed using a 11-point NRS
Timepoint [2] 340966 0
at the end of the intervention
Secondary outcome [3] 340967 0
patients' experienced general side effects over all from their current biologic drug assessed using a 11-point NRS
Timepoint [3] 340967 0
at the end of the intervention
Secondary outcome [4] 340968 0
patients' expected general side effects over all from a biosimilar assessed using a 11-point NRS
Timepoint [4] 340968 0
at the end of the intervention
Secondary outcome [5] 340969 0
patients' perceived safety of their current biologic drug assessed using a 11-point NRS
Timepoint [5] 340969 0
at the end of the intervention
Secondary outcome [6] 340970 0
patients' expected safety of a biosimilar assessed using a 11-point NRS
Timepoint [6] 340970 0
at the end of the intervention
Secondary outcome [7] 340971 0
patients' general concerns overall about taking a biosimilar assessed using a 11-point NRS
Timepoint [7] 340971 0
at the end of the intervention
Secondary outcome [8] 340972 0
patients' anxiety to switching from their biologic drug to a biosimilar assessed using a 11-point NRS
Timepoint [8] 340972 0
at the end of the intervention
Secondary outcome [9] 340973 0
patients' preference to take a biosimilar versus a biologic drug assessed using a 11-point NRS
Timepoint [9] 340973 0
at the end of the intervention
Secondary outcome [10] 340978 0
level of how convincing patients perceived the explanation assessed using a 11-point NRS
Timepoint [10] 340978 0
at the end of the intervention
Secondary outcome [11] 340979 0
level of how reassuring patients perceived the intervention assessed using a 11-point NRS
Timepoint [11] 340979 0
at the end of the intervention
Secondary outcome [12] 340980 0
patients' general understanding of the explanation ("How easy was the explanation to understand?) assessed using a 11-point NRS (0 = not at all, 10 = extremely)
Timepoint [12] 340980 0
at the end of the intervention
Secondary outcome [13] 340981 0
patients' attitude with regards to how important it is that physicians talk with their patients, who are prescribed with a biologic, about the option of taking a biosimilar assessed using a 11-point NRS
Timepoint [13] 340981 0
at the end of the intervention

Eligibility
Key inclusion criteria
Participants will be included in this study if they:
- are patients attending an appointment with their rheumatologist/dermatologist at a clinic across the Auckland District Health Board,
- are 18 years of age or over,
- take a biologic medication (e.g., Humira, Enbrel, infliximab, rituximab, tocilizumab).
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)
sealed opaque envelopes
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. The randomisation will be conducted by a person being independent of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis conducted with G*Power showed that a total sample size of 96 patients is required to detect a clinically meaningful large effect size of f = 0.40 on a mean score on willingness to switch. This is with 4 groups, a power of 0.80 and an alpha of 0.05.

Data will be checked for the assumptions of parametric statistics before being analyzed in SPSS and SAS. An analysis of variance (ANOVA) will be conducted to examine group differences on continuous measures. Logistic regression will be used to examine the binary outcomes and a significance level of <.05 will be maintained for all analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2018
Actual
1/03/2018
Date of last participant enrolment
Anticipated
15/12/2018
Actual
15/12/2018
Date of last data collection
Anticipated
31/12/2018
Actual
31/12/2018
Sample size
Target
96
Accrual to date
Final
96
Recruitment outside Australia
Country [1] 9403 0
New Zealand
State/province [1] 9403 0

Funding & Sponsors
Funding source category [1] 298104 0
University
Name [1] 298104 0
University of Auckland
Country [1] 298104 0
New Zealand
Primary sponsor type
Individual
Name
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] 297181 0
Individual
Name [1] 297181 0
Nicola Dalbeth
Address [1] 297181 0
Faculty of Medical and Health Sciences
School of Medicine
University of Auckland
Building 502
85 Park Road
Grafton, Auckland 1023
Country [1] 297181 0
New Zealand
Other collaborator category [1] 279840 0
Individual
Name [1] 279840 0
Paul Jarrett
Address [1] 279840 0
Counties Manukau District Health Board
Private Bag 93311
Otahuhu, Auckland 1640
Country [1] 279840 0
New Zealand
Other collaborator category [2] 279841 0
Individual
Name [2] 279841 0
Maria Kleinstaeuber
Address [2] 279841 0
Faculty of Medical and Health Sciences
School of Medicine
Department of Psychological Medicine
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
Country [2] 279841 0
New Zealand
Other collaborator category [3] 279842 0
Individual
Name [3] 279842 0
Rob Horne
Address [3] 279842 0
UCL School of Pharmacy
BMA House
Tavistock Square
London
WC1H 9JP
Country [3] 279842 0
United Kingdom
Other collaborator category [4] 279848 0
Individual
Name [4] 279848 0
Chiara Gasteiger
Address [4] 279848 0
Faculty of Medical and Health Sciences
School of Medicine
Department of Psychological Medicine
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
Country [4] 279848 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299124 0
Health and Disability Ethics Committees
Ethics committee address [1] 299124 0
Ethics committee country [1] 299124 0
New Zealand
Date submitted for ethics approval [1] 299124 0
30/11/2017
Approval date [1] 299124 0
Ethics approval number [1] 299124 0
Ethics committee name [2] 299136 0
Auckland District Health Board
Ethics committee address [2] 299136 0
Ethics committee country [2] 299136 0
New Zealand
Date submitted for ethics approval [2] 299136 0
15/12/2017
Approval date [2] 299136 0
21/03/2018
Ethics approval number [2] 299136 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79378 0
Prof Keith Petrie
Address 79378 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 79378 0
New Zealand
Phone 79378 0
+6493737599 ext: 86564
Fax 79378 0
Email 79378 0
kj.petrie@auckland.ac.nz
Contact person for public queries
Name 79379 0
Keith Petrie
Address 79379 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 79379 0
New Zealand
Phone 79379 0
+6493737599 ext: 86564
Fax 79379 0
Email 79379 0
kj.petrie@auckland.ac.nz
Contact person for scientific queries
Name 79380 0
Keith Petrie
Address 79380 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 79380 0
New Zealand
Phone 79380 0
+6493737599 ext: 86564
Fax 79380 0
Email 79380 0
kj.petrie@auckland.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


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.