Information provided after a participant stops or reduces their participation may serve a more supportive purpose.
Participants who stop or reduce their participation before it was originally due to end may have specific ‘information needs’, particularly as stopping participation can be a difficult experience (based on reports from Ulrich, Wilson, Eborall and colleagues).
Participants may wonder what will happen next with their care or their involvement in the trial. They may not remember all the detail given before about the implications of stopping participation, so may appreciate a reminder.
Some of the relevant information may be conveyed routinely by clinical staff, for example about what will happen next regarding participants’ care, or any specific arrangements for safely stopping trial intervention.
Other points might not always be covered, for example confirming exactly how participation has changed and which aspects of participation may continue.
When any aspects of participation stop because of decisions made by people other than the participant, the participant should have the decision and rationale explained to them and have the chance to ask questions of an appropriate person.
CTUs may be able to provide training and tools to help ensure trial site staff convey all of these other points, verbally or in writing (see Training and Support).
Written communications
It may be useful to provide participants with a written communication at the time they stop or significantly reduce their participation (i.e. an ‘end of participation information sheet’ or similar).
This can explain to participants what will happen next, confirm exactly how their participation has changed, remind them of the implications of changing their participation, and remind them what choices remain for them about their participation.
It can also include a reminder of any aspects of participation that are continuing, either because participants’ rights to stop or undo them are limited, or because a ‘presumed ongoing consent’ approach applies. Where such an approach applies, participants can be reminded how to say they want those aspects to stop, if that is what they want.
The information sheet could also confirm to participants what further contact they should expect about the trial (if any), based on their previously given contact preferences.
Detailed guidance is available for trial teams who would like to implement this sort of written communication, or otherwise to consider how to communicate these points to participants.
Communicating with participants who have lost contact with the trial
It is conceivable to send a similar communication when trial staff have lost contact with participants (based on the protocol’s definitions and guidance about this – see Protocol Development) as long as the participant’s main contact details are thought to still be correct.
This could include similar information to the communication mentioned above, with confirmation of the participant’s change in participation status, and any information about what further attempts at regaining contact (if any) the participant might expect.
Providing feedback
As well as asking participants if they would be willing to provide information on their reasons for changing their participation, it may be useful to ask if they have any feedback on their experience in the trial.
This could be useful to help improve the trial processes (with potential knock-on benefits for recruitment or retention) and improve participants’ experiences participating in trials more generally.
It is even not out of the question that this feedback process could lead to further discussion about difficulties the participant experienced in the trial, and ways they could, in fact, continue to contribute.
This should not be ruled out, as long as the decision is informed and freely given (see principle O2 – participants decide how their participation changes), though it would be understandable if trial staff only felt comfortable to discuss this if the participant instigated that conversation.