Over the next few months we will contribute a series of articles outlining how we have involved consumers in the Million Minds research program, what we have learned and how we might improve things in the future.
When the “Kids are not Ok” program of research was funded by the Medical Research Futures Fund, we felt that it would be critical to get consumer advisors involved in the development, design and ongoing roll-out of the research. In this article we will describe how we involved the Kids are Not OK Consumer Advisor group in the development of:
Pharmacological Emergency Management of Agitation in Children and Young People – A randomised controlled trial of oral medication.
Pharmacological Emergency management of Agitation in Children and Young people – A randomised controlled trial of IntraMuscular medication
Where and when did we start….
When the study protocols were being drafted, we decided we needed to consult with consumers about how participants would be recruited in the ED and how consent would be obtained. The reality was that we wanted to obtain a waiver of consent to recruit children into the study but needed to sound this out with parents to determine if this was reasonable.
What did we do….
Meeting 1 (online via zoom)
- Warm up – introductions were made, our parent consumers talked about their lived experience of attending the ED with their children who had mental health issues.
- Elyssia explained the rationale for embarking on this trial and summarised the trial overview (including non-medication ‘de-escalation’ attempts and trial drugs), what the studies were about and what they aimed to do.
- Questions about the study in general were invited and discussed in the group.
- Elyssia presented our intent to obtain a waiver of consent for this trial and listed the rationale, benefits and potential risks.
- All consumer advisors were invited to comment on how they felt about recruitment under a waiver of consent. All expressed their understanding and were comfortable with the waiver – given the stressful circumstances in the ED.
- Parents were also in favour of being notified that participants were enrolled in a trial and that their (de-identified) data would be collected.They wanted to receive information about:
– Background information on acute severe behavioural disturbance and treatment methods, trial purpose, intended outcomes and the trial drug/s their child received.
- Detailed minutes of the meeting were taken.
- Essential points of the discussion were incorporated into the study protocol in a specific section about consumer involvement.
- It was agreed that we would also get input into the participant information to be developed.
Follow up email consultation
- Consumers were consulted via email re drafting of the participant information form.
- Consumers had the opportunity to review and provide feedback on the participant information form prior to this being submitted for ethical review.
- We successfully obtained a waiver of consent from the lead HREC for the study and this has been accepted at most interstate sites.
What we learned about working with consumers to design our protocol and materials….
- It takes time – ideally start early!
- Careful facilitation of the meetings is important taking care to involve everyone and allow time for discussion and different points of view to be raised.
- Consumers often contribute ideas that clinicians may have missed!
- Consumers are generally very accepting of ideas such as a waiver of consent that are viewed as posing significant ethical risks. To ensure this acceptance, a clear explanation and justification of why this is the best approach and how it will improve the experience for the young person and their family members when they participate in the trial is required.
- Careful write up in the protocol of how consumers have been involved in development of the study has been valuable for obtaining ethics approval.