Trial 3

Supporting informed consent

Trial 3

Can a self-reflection tool for clinicians improve informed consent conversations between clinicians and patients?

Before consenting to treatment, patients need to understand their treatment options and the impact of the potentially life-changing decisions they are about to make.

Clinicians should discuss the diagnosis, the options available to them and clearly explain the risks, benefits and likely outcome of treatment in a way that meets the patient’s needs, goals and levels of comprehension.

While ‘fully informed consent’ is optimal, there is evidence to suggest that it is sometimes sub-optimal (i.e., not all processes are followed) or, in serious cases, not obtained at all. Failure to obtain consent can lead to decisional regret and negative impacts on the patient’s quality of life, health outcomes and experiences of the health system.

The aim of this trial (halted due to COVID-19) was to explore the feasibility, acceptability and effect of a behavioural self-reflection tool to improve consent conversations.

What did the literature tell us?

The first phase of this trial involved a Facilitated Dialogue with key stakeholders.

To ensure that participants had a good understanding of the issue – and what others around the world had done to address it – they were briefed with the results of a Rapid Evidence and Practice review (below).

The first phase of this trial involved a Facilitated Dialogue with key stakeholders.

To ensure that participants had a good understanding of the issue – and what others around the world had done to address it – they were briefed with the results of a Rapid Evidence and Practice review (below).

Briefing document PDF

What's likely to fix the problem?

From the Facilitated Forum Dialogue, participants drew the following conclusions on how to improve informed consent discussions.

Dialogue summary PDF

What did we plan to do?

Trial did not proceed due to COVID-19

We had intended to pilot a self-reflection tool, which consisted of a series of questions prompting clinicians to reflect on their conversations with patients being recommended for elective surgery.

The tool covered different parts of an informed consent conversation (e.g., setting the scene, personalising, confirming and opportunity for questions), reminding clinicians of the competencies required for ideal informed consent conversations and how to use these skills in subsequent conversations.

The tool was refined through a prioritisation process with input from key stakeholders, including a patient advocate, communications researcher, risk adviser, insurance claims specialist and policy/government representatives.

What did we find?

While the trial was not able to go proceed due to COVID-19, development of the self-reflection tool resulted in an evidence-based intervention that is ready for testing.