13. A Pathway for Communication and Decision-Making
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What Strategies Can Help?
We know that communicating and making decisions about clinical trial participation are complex. In this section we will be talking about strategies that can help in these discussions. A study by Albrecht et al colleagues videotaped consultations involving 12 oncologists who were discussing clinical trial participation with 48 individual patients. The study found that when patients agreed to take part in a trial, the oncologist had given more information about the research, that is, why it was being done, the trial itself, that is, what was involved, and the side effects and benefits of trial treatments. They also used the participant information sheet during the consultation, and oncologists responded more to patient concerns and questions during the consultation, suggesting that communication could make a difference to patient choice about participation in a clinical trial.
Ideal Practice
A group of Australian researchers explored the practice of informing the patients about cancer clinical trials. They developed a training workshop to allow health professionals to develop skills in communicating about clinical trials on a background of shared decision-making. They did this by comprehensively examining the available evidence by reviewing the scientific literature, analysing audio recorded consultations to hear what occurred during the discussions, and developing a consensus statement about ideal informed consent processes in clinical trials with the views of relevant stakeholders represented. They ran training workshops to develop and refine the training module with oncologists and subsequently breast surgeons. The workshops have subsequently been adapted for use in training health professionals in obtaining informed consent in specific trials, particularly trials in which patients perceive a big difference between the treatments being studied.
Four Key Concepts
The workshops developed were underpinned by four key concepts. These were, firstly, the need to establish the patient and healthcare professionals as a team working together, helping patient understanding as well as the expectation of full disclosure about trials, treatments and their risks and benefits, while avoiding coercion of patients to participate, and finally, following a consultation pathway. We will talk about each of these concepts in more detail now.
Establishing the Team
The first concept of establishing the team and shared decision-making can be assisted by explicitly offering joint or shared decision-making involving the patient and healthcare professional. In order to do this effectively, it is important that the health professional understand how much information the patient wants to know and how involved they want to be in decision-making. To do so, it is necessary to check the patient’s preference for the amount of information and the level of involvement in decision-making. Knowing what a patient is already of about their condition and their personal medical knowledge can help a health professional to start their discussion at a level appropriate for an individual patient. Thus it is important to check patient understanding and medical knowledge. Many people find asking questions of health professionals difficult. To establish the team relationship, health professionals need to explicitly invite questions and comments from patients. They can also portray the patient as an active participant in the discussion and decision-making process. Clearly outlining all of the treatment options is also helpful in demonstrating that clinicians and patients need to work together to come to a decision appropriate for the individual.
Tool Box
A tool box are strategies health professionals can use was identified. These aids were perceived to clarify information and support the communication. There are four groups of strategies or tools included. These are non-verbal cues and behaviour, language, communication aids and validation. Non-verbal cues reflect the importance of the physical environment, such as how the room is arranged, as well as those non-verbal cues picked up through body language, including eye contact in the presence of the health professional, for example, are they busy? Language refers to the language health professionals in their communication. Things like using open questions, simple or plain language, using analogies to convey a message or depict a concept, and finding some good lines that seem to help people in their understanding. Physical aids refer to materials to support the discussion such as diagrams, question prompt lists or trial information sheets. Validation involved acknowledging the patient’s situation, their emotions and feelings as being normal, that they are able to ask questions, the decision style they prefer, as well as taking the time they need with the health professional and outside the consultation with family and friends, and others, before making a decision about treatment.
Non-Coercion
Non-coercion, that is not applying pressure to an individual to do something they don’t want to do can be fostered by using language that is not valued laden. For example, the term “eligible” for a trial suggests that the patient is lucky or has won something by being eligible. Rather, the trial maybe “suitable” or a suitable treatment option for an individual. Having the patient involved in the treatment decision-making can help to ensure their preferences are considered. Although ultimately a patient may defer the decision to the health professional. Giving sufficient time to discuss treatment options and giving people time to decide on treatment can help to avoid coercion, some what like a cooling off clause, allowing the same time for discussion of all of the treatment options and ensuring that they are all covered in sufficient detail. Things to avoid again include being mindful of language, avoid asking patients if they will join the trial or have standard treatment, as well as avoiding the minimisation of side effects of one treatment over the other.
Following a Consultation Pathway
So how does a health professional conduct an ideal consultation? What we will describe now follows a consultation pathway aimed at supporting informed consent to treatment and/or clinical trials. The first stage is the bearings in which you establish rapport and ensure you and the patient have shared understanding of what has gone on up until now. If the bearings component is not managed properly, communication will break down and you will be at cross-purposes for the rest of the consultation. The next fundamental issue is what we call pathway one, and that is the discussion of standard treatment options. These should be discussed in enough detail for the patient to have a very clear idea of those options before the concept of a clinical trial in introduced, otherwise the patient may get the message that the clinical trial is the only acceptable option. It is also important before moving to pathway two to acknowledge that you are about to add a whole level of complexity to the discussion and to gain the participant’s agreement to move to that phase.
Next you can see that there are three components in both pathways which occur after an explanation has been provided. Amplification means giving the patient an opportunity to express their reactions to the treatment options presented, what it will mean for them in their own individual circumstances, and to begin to weigh up the benefits and costs to them of each option. Probably, of all of the components, this is the one most likely to be absent in current practice. Note, that in amplification one, the patient is responding to the standard treatment option whereas in amplification two, they are responding to the idea of being on a clinical trial and the additional burdens and opportunities that this may entail. We also think that the doctor should make their own recommendation explicit, because if it is implicit then it is more likely to be coercive.
Annunciation is a separate component where the patient articulates their decision, even if this is asking the doctor to make the decision, or to delay decision-making. We think it is important for this to happen at the end of pathway one because if the patient decides against chemotherapy, for example, then it is pointless to go on and talk about a clinical trial of chemotherapy.
After all of that has been achieved, the doctor needs to implement the decision or describe the next steps, and this is called enactment. If you would like to see how this might be enacted, please refer to the example that follows this presentation about consenting to a specific study, that is, a study of surgery alone versus chemoradiation followed by surgery for resectable oesophageal cancer.
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