None listed
Conditions
Brief summary
Biosimilars or the nonidentical counterparts of biologics enable more access to treatment for patients and are more cost-effective for the healthcare system. However, physicians have reported a lack of confidence in explaining switching from biologic drugs to biosimilars to patients. This study aims to examine how physicians can effectively explain biosimilars to patients currently treated with biologic drugs to increase their willingness to switch from a biologic to a biosimilar drug, and to improve their understanding and also perceptions of the efficacy and safety of a biosimilar. This will be accomplished by using an analogue study of a hypothetical scenario regarding future treatment whereby patients will be given an explanation on switching. The intervention uses either a positive or a negative framing to emphasize either the similarities or differences respectively between biologic drugs and biosimilars. Moreover it uses an analogy in order to explain the process of manufacturing a biosimilar. The study implies a 2x2 factorial design and participants will be randomised into one of four conditions: 1) positive-framing and analogy explanation, 2) positive-framing only explanation, 3) negative-framing and analogy explanation, and 4) negative-framing only explanation. The findings will demonstrate how framing and the use of a nontraditional analogic explanation can affect patients’ perceptions of biosimilars. We will assess participants' willingness to switch from a biologic drug to a biosimilar. Secondarily we will measure the participants' understanding, perceptions of safety and efficacy of biosimilars as well as their attitudes towards the explanation. We hypothesize that participants in the positive-framing and analogy explanation group will be more willing to switch from a biologic drug to a biosimilar, will have more positive perceptions of the safety and efficacy of biosimilars, and will have more positive attitudes towards the explanation than participants in the active control groups. These findings will help physicians effectively explaining to patients how to switch from a biologic drug to a biosimilar .
Interventions
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
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.
Sponsors
Keith Petrie
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
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
None listed