Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001103853
Ethics application status
Approved
Date submitted
12/07/2021
Date registered
18/08/2021
Date last updated
20/07/2022
Date data sharing statement initially provided
18/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
How can health care professionals explain biosimilars? An assessment of a mock consultation involving ‘family-centered’ communication.
Scientific title
The effect of a brief 'family-centered' communication intervention on the hypothetical decision to transition from a bio-originator to a biosimilar in healthy volunteers.
Secondary ID [1] 304702 0
None
Universal Trial Number (UTN)
U1111-1267-6309
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health-related decision making 322715 0
Patient-provider-companion communication 322716 0
Condition category
Condition code
Public Health 320306 320306 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Family-Centered Consultation:

This intervention is a one-off, 10-minute mock consultation delivered at the University of Auckland Clinical Research Centre. The intervention aims to optimize patient decision-making by exploring how to best involve companions in consultations and clarify the companion's role in the decision-making process.

Following completion of the baseline questionnaire, participants will receive standardized information on a bio-originator therapy and a letter informing them of the potential to transition to a biosimilar. Participants will receive approximately 5-10 minutes to thoroughly read this information. These resources were designed specifically for this study, with input from a rheumatologist and a patient with 4 years of experience using the bio-originator.

A healthcare provider will provide information on transitioning to biosimilars to participants in the mock consultation. The mock consultation will occur immediately after participants have read the standardized information and letter. The companion will be involved throughout the consultation (e.g., some practical information will be directed to the companion, and they will be encouraged to discuss the decision to transition with the patient). Companions will also be asked if they have any questions following the explanation about biosimilars. Non-verbal cues will accompany the verbal information, such as the healthcare provider leaning forward, facing the dyad, and using gaze when communicating. The session will only involve healthy participants and their companion discussing a hypothetical treatment change and no drug treatments will be given or changed as part of the study.
Intervention code [1] 321084 0
Behaviour
Comparator / control treatment
Standard Care:

The control group involves a one-off, 10-minute mock consultation delivered at the University of Auckland Clinical Research Centre.

Participants will receive the same standardized information on a bio-originator therapy and a letter informing them of the potential to transition to a biosimilar as the intervention group. Participants will also receive approximately 5-10 minutes to thoroughly read this information before attending the mock consultation.

The mock consultation will occur immediately after participants have read the standardized information and letter. The healthcare provider will briefly acknowledge the companion at the beginning of the mock consultation, with the remaining consultation being solely focused on the patient. Negative non-verbal and physical cues will be used, including not gazing at the companion, primarily facing the participant, and seating the companion to the side of the room. The session will only involve healthy participants and their companion discussing a hypothetical treatment change and no drug treatments will be given or changed as part of the study.
Control group
Active

Outcomes
Primary outcome [1] 328157 0
Patients' willingness to transition from a bio-originator drug to a biosimilar assessed using a binary response (Yes/No).
Timepoint [1] 328157 0
Immediately post-intervention.
Secondary outcome [1] 397869 0
Decision satisfaction will be measured using the Satisfaction with Decision Instrument (Holmes-Rovner et al., 1996).
Timepoint [1] 397869 0
Immediately post-intervention.
Secondary outcome [2] 397870 0
Satisfaction with the general encounter will be measured using an adapted version of the Short Patient Satisfaction Questionnaire (items assessing financial aspects and accessibility of care were removed) (Marshall & Hays, 1994).
Timepoint [2] 397870 0
Immediately post-intervention.
Secondary outcome [3] 397871 0
Satisfaction with the communication will be measured using the 9-item Patient Perception Scale, which measures the degree to which the communication is patient-centered (Reinders et al., 2009; Stewart et al., 2000).
Timepoint [3] 397871 0
Immediately post-intervention.
Secondary outcome [4] 397872 0
Participant involvement will be measured using two 11-point Likert scales- to rate their own involvement in the decision and the encounter in general (Gasteiger, Groom, et al., Under Review).
Timepoint [4] 397872 0
Immediately post-intervention.
Secondary outcome [5] 397874 0
To measure understanding, one 11-point Likert scale will be used ("How easy was the explanation to understand?").
Timepoint [5] 397874 0
Immediately post-intervention.
Secondary outcome [6] 398116 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 [6] 398116 0
Immediately post-intervention.
Secondary outcome [7] 398117 0
Three 11-point (0 = not at all, 10 = extremely) Likert scales will assess how reassuring and easy the explanation was to understand and participant confidence in knowledge.
Timepoint [7] 398117 0
Immediately post-intervention.
Secondary outcome [8] 398118 0
One item will be used to assess emotional support received from the companion (“I received emotional support from my companion (e.g., felt listened to)” (Berli et al., 2018; Gasteiger, Groom, et al., Under Review). Participants have five response options to choose from ranging from strongly agree to strongly disagree.
Timepoint [8] 398118 0
Immediately post-intervention.
Secondary outcome [9] 399013 0
Companion involvement will be measured using two 11-point Likert scales- to rate the companion's involvement in the decision and the encounter in general (Gasteiger, Groom, et al., Under Review).
Timepoint [9] 399013 0
Immediately post-intervention.
Secondary outcome [10] 399017 0
One item will be used to assess informational support received from the companion (“I received informational support from my companion (e.g., advice, suggestions)”) (Berli et al., 2018; Gasteiger, Groom, et al., Under Review). Participants have five response options to choose from ranging from strongly agree to strongly disagree.
Timepoint [10] 399017 0
Immediately post-intervention.
Secondary outcome [11] 399018 0
Six questions will also be used to measure understanding. These require participants to recall key information from the explanation, including defining a biosimilar. Participants will be required to write their responses in the lined space provided. These questions derive from information that patients have reported wanting to know in previous research (Gasteiger et al., 2020).
Timepoint [11] 399018 0
Immediately post-intervention.

Eligibility
Key inclusion criteria
All participants must be 18 years of age or over, able to fill out the questionnaires, willing to participate, and fluent in the English language. Participants and companions must have known each other for at least six months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any participants who are unable to fill out the questionnaires, are unwilling to participate, and/or cannot understand, read, or write English will be excluded.

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 randomization strategy will be applied using a randomization table created by computer software. The randomization will be conducted by a person independent of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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
23/08/2021
Actual
16/02/2022
Date of last participant enrolment
Anticipated
Actual
30/03/2022
Date of last data collection
Anticipated
Actual
31/03/2022
Sample size
Target
52
Accrual to date
Final
54
Recruitment outside Australia
Country [1] 23950 0
New Zealand
State/province [1] 23950 0

Funding & Sponsors
Funding source category [1] 309070 0
University
Name [1] 309070 0
University of Auckland
Country [1] 309070 0
New Zealand
Primary sponsor type
Individual
Name
Professor Keith Petrie
Address
Faculty of Medical and Health Sciences, Department of Psychological Medicine.
University of Auckland Grafton Campus, 22-30 Park Avenue.
Grafton, Auckland, 1023
Country
New Zealand
Secondary sponsor category [1] 310073 0
Individual
Name [1] 310073 0
Chiara Gasteiger
Address [1] 310073 0
Faculty of Medical and Health Sciences, Department of Psychological Medicine.
University of Auckland Grafton Campus, 22-30 Park Avenue.
Grafton, Auckland, 1023
Country [1] 310073 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308946 0
Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 308946 0
Ethics committee country [1] 308946 0
New Zealand
Date submitted for ethics approval [1] 308946 0
17/06/2021
Approval date [1] 308946 0
23/07/2021
Ethics approval number [1] 308946 0

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

Contacts
Principal investigator
Name 112426 0
Prof Keith Petrie
Address 112426 0
M&HS Building 507, Level 3, Department of Psychological Medicine
University of Auckland Grafton Campus, 22-30 Park Avenue.
Grafton, Auckland, 1023
Country 112426 0
New Zealand
Phone 112426 0
+64 9 923 6564
Fax 112426 0
Email 112426 0
[email protected]
Contact person for public queries
Name 112427 0
Keith Petrie
Address 112427 0
M&HS Building 507, Level 3, Department of Psychological Medicine
University of Auckland Grafton Campus, 22-30 Park Avenue.
Grafton, Auckland, 1023
Country 112427 0
New Zealand
Phone 112427 0
+64 9 923 6564
Fax 112427 0
Email 112427 0
[email protected]
Contact person for scientific queries
Name 112428 0
Keith Petrie
Address 112428 0
M&HS Building 507, Level 3, Department of Psychological Medicine
University of Auckland Grafton Campus, 22-30 Park Avenue.
Grafton, Auckland, 1023
Country 112428 0
New Zealand
Phone 112428 0
+64 9 923 6564
Fax 112428 0
Email 112428 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.