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How can health care professionals explain biosimilars? An assessment of a mock consultation involving ‘family-centered’ communication.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001103853
Enrollment
54
Registered
2021-08-18
Start date
2022-02-16
Completion date
2022-03-30
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Companions are often present and support patients during routine treatment decisions. However, there is limited research on how physicians can effectively involve companions during these discussions to improve patient decision-making. This study aims to examine whether a brief family-centered communication intervention optimizes patient decision-making. It is hypothesized that participants in the intervention group will be more willing to transition, report more companion involvement, and have more understanding, and higher satisfaction. A community sample consisting of participants ('patients') and their companions will receive information on bio-originators and a letter informing them of the hypothetical decision to transition to a biosimilar. Participants will be randomized to attend a mock consultation delivered by a health care professional that employs either family-centered communication or standard care.

Interventions

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 the

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.

Sponsors

Professor Keith Petrie
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026