Involving medical companions in an explanation about switching to a biosimilar.

The influence of medical companions on a patient’s hypothetical decision to switch to a biosimilar.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001435178

Enrollment

Registered

2019-10-16

Start date

2019-12-17

Completion date

2020-10-29

Last updated

2021-05-10

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

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Educational / counselling / training

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

Participants will be excluded from this study if they: - are unable to fill out the questionnaires, - cannot understand, read or write English.

Outcome results