Training and support for trial sites

Training materials about approaches to managing participation changes could include: 

• The main messages from the PeRSEVERE principles, with rationale. The overarching principles that guide the overall approaches to managing participation changes might be emphasised in particular. The overall aim could be highlighted, namely to prepare for and manage participation changes in ways that uphold the interests of participants and the trials they take part in. 
• Opportunities for trial site staff to talk through any concerns, misunderstandings or disagreements with the messages presented. This could help establish a shared understanding of what is expected when managing participation changes. This may be important, as previous evidence suggests that trial processes around managing participation changes can sometimes conflict with individuals’ ‘moral compass’.
• Recognition that it can be challenging to accommodate the needs of trial participants (respecting any wishes to stop data collection, and taking time to establish what participants’ wishes about data collection are), and trials (to continue collecting outcome data where possible), particularly as each trial’s requirements may differ.
• The need for all involved in trials (in any capacity) to understand the potential complexity in participation changes and to use language and terminology to match (see principle O1 – participation can stop, reduce or change). This should be reflected in the data reported to CTUs about participation changes. It is important for CTUs to know exactly how participation has changed (including if participants’ wishes about any aspects of participation are not known).
  • This could be reflected in training materials by separating content about different sorts of participation change (e.g. stopping intervention after clinical decisions, losing contact with participants, responding to participants’ wishes).
• The importance of collecting as much of the planned data as possible (see principle O3 – the more data, the better), with a particular focus on trial outcome data.
  • Training could cover what this idea means (and does not mean) in practice, with example scenarios and what the best action might be in each case (in terms of participants’ rights and trials’ integrity).Training may include a hierarchy of data importance within a trial, though this should not inadvertently imply that data below the top level is unimportant.
  • It is likely preferable to express the importance of trial data to participants ‘positively’, i.e. in terms of the benefits of collecting as much as possible of the planned data. However, it could be useful for trial site staff to understand the possible negative effects missing data can have on trial results.
• The idea that trial data collection continues until the participant says they want it to stop, the conditions that need to apply to make this approach valid, and the role of trial site staff in applying the approach (see principle O5 – continuing data collection, and Policies and Processes). 
• Confirmation that, if a participant does say they want data collection to stop, data already collected is retained (see principle O6 – retaining data) and data generated prior to that point can also still be collected, with some trial-specific exceptions (see principle O5 – continuing data collection and Policies and Processes).

Training materials about informed consent and participant communication could include: 

• Information to convey during initial consent about participation changes (see principles D3 and D4), including the following points:
  • How participants can express a wish to change participation later on.
  • Limitations on participants being able to stop or undo aspects of participation.
  • Details of any activities that would carry on until the participant says they want them to stop (see principle O5 – continuing data collection), including how to express such a wish (e.g. what sort of thing would be taken as confirmation that they want those elements to stop).
  • It may not be helpful to give details up front about specific ways that participation could be reduced. However, it could help to convey that there may be other options if the participant is later struggling to continue participating in all aspects of the trial (see Patient Information, Participant Communication and Consent).

• Encouragement to have dialogue wherever needed about participation changes, both with participants (see principle D5 – encouraging dialogue) and with CTUs (to discuss individual cases or to seek advice).
  • Training on this point could include trial-specific expectations about what would constitute ‘reasonable efforts’ to check participants’ ongoing willingness to take part. This could link with trial-specific processes or expectations around checking participants’ ongoing capacity to consent.
  • Trial site staff can be encouraged to use their own judgement about what constitutes reasonable efforts to check ongoing willingness. This may depend on their relationship with each particular participant. The nature of the involvement may also be relevant, for example the amount of commitment or risk required from participants, or whether any ‘implied consent’ might apply.
• Emphasis on communication with participants being balanced and positive, i.e. there is no ‘wrong choice’ for participants about their level of involvement in the trial.
• Communication should also be realistic, recognising that it is completely understandable that participants sometimes cannot complete all parts of a trial.
• Participants should also understand that in some cases there are limitations on what types of participation or contributions will actually help the trial meet its objectives.
• Advice about how to talk to participants about topics where staff may worry about the risk of appearing to put pressure on participants. This includes, for example, about the benefit of collecting more of the planned trial data (see principle O3 – the more data, the better), ‘presumed ongoing consent’ approaches*, asking participants if they would be happy to give a reason for changing their participation, or what would happen if trial staff and participants lose contact with each other.

* This means participants’ consent to a particular trial activity is presumed to be ongoing if the participant has not said they want that activity to stop, as long as certain conditions are met. For more details, see PeRSEVERE principle O5.

Training materials about managing specific participation change situations could include:

• Confirmation that trial staff should assess each individual situation for its specific features and sensitivities, and prioritise participants’ rights. This includes stopping all trial activities where assumptions supporting participants’ ongoing consent may be unreliable or where participants may not reasonably expect activities to be continuing.
• Emphasising that when a participant says they want to stop or reduce their participation, it does not mean they need to stop all involvement. There can be benefits to participants of further involvement in the trial. They may also wish to continue contributing if it is possible. It is therefore important to establish what each participant wants to do when they say they want to stop or reduce their participation.
• Emphasising that the nature and extent of participation changes should be participants’ decision (see principle O2 – participants decide how their participation changes). Decisions by others to stop aspects of participation – in particular stopping trial intervention – should only apply to those specific aspects.
• The need to explore whether a change in trial site could help the participant continue contributing to the trial, if they want to. This could include where the participant will be moving home or where the travel to the current site is proving to be a challenge).
• Guidance and expectations for establishing what a participant wants to do when they say they want to stop or reduce their participation. This includes helping them understand their choices and the pros and cons of different options, and ways to facilitate participants’ decision-making (e.g. to remind them of their choices).
  • Where an optional form is used for participants to make clear how they want their participation to change, trial staff could get guidance on how they can help participants complete this (see Other ways to support freely-given participant decisions).
• Information about possible flexibilities in each trial’s follow-up procedures. This could include an understanding of participation ‘tiers’ (see Protocol Development) and advice about when to broach these with participants (see Patient Information, Participant Communication and Consent).
• Reminders to communicate clearly with participants if aspects of participation stop when it was not participants’ choice (or if the trial design means participants can no longer take part in some or all of the trial), providing clear reasons for the change and giving participants opportunities to ask questions (see Patient Information, Participant Communication and Consent).   
• Expectations around record-keeping for all types of participation change. This includes keeping a clear record of participants’ wishes about participation changes, and any discussions had about these, in medical notes or other source records.
  • Sites should also use their own records of participant wishes to ensure those wishes are carried out, for example with regard to further data collection for the trial, or receiving further contact about the trial.
• What is practically expected of trial staff in cases where they are unable to contact research participants (see principle O4 – losing contact), including handling potential sensitivities and taking a cautious approach to attempting re-contact.
• Advice about how to ask participants if they might be happy to provide any information about why they want to change their participation.
  • Training for trial staff can provide an understanding of what sort of information is useful, why it can help the trial, and what level of detail is adequate.
  • Training can emphasise a balance between the acceptability (in most cases) of trial staff asking participants for their motivations and participants’ right to refuse to provide any information.
• Advice about how to ask participants if they are willing to provide trial outcome data when they stop or reduce their participation (if it would help the trial’s objectives).
• Confirmation that stopping participation does not automatically remove participants’ rights to receive relevant information that they might want or need (see principle O7 – information after stopping participation).
  • Training could clarify what is expected from trial staff in finding out participants’ preferences for further contact when they stop or reduce their participation, and maintaining contact after this point.
• It may be useful to present common scenarios that may arise and what would be expected from trial staff in these scenarios.
• Any other trial-specific practical steps to take when managing participation changes.

Tools and templates could include:

• A checklist or “crib sheet” for trial staff to use when managing different sorts of participation change, including to sensitively guide discussions with participants. Template checklists are available in Resources.
• Templates for trial staff to use when attempting to regain contact with participants who they have lost contact with. This could help standardise the approach to minimise the risk that re-contact attempts seem intrusive or insensitive.
• Templates to check participants’ preferences for further contact about the trial after they stop participating.
• Template ‘source data sheets’ in case they could help to obtain further, relevant information about trial participants from NHS organisations who are not participating in the trial. This approach may be useful when participants and trial staff have lost contact with one another. These source data sheets could be completed by the non-trial sites and provided back to trial sites, where they could be used to complete trial data collection forms. Such contact with non-trial sites may need to rely on participant consent in some cases.