4. On Study
Clear information about ongoing research procedures, data collection and reporting
“On Study” is the time when the participant is enrolled into the specific research study and undergoes the research procedures outlined in the protocol.
- At this point the focus of the research team is on quality data collection, compliance with the research procedures and retention of enrolled participants.
- Ongoing clear communications about expectations and logistics are important.
- It is advised that any materials and scripts used during the ongoing study should go through usability testing with members of the intended audience.
- Through a process of ongoing engagement and active listening, researchers should periodically confirm participants understanding of the research and willingness to continue as the study proceeds
Click through the individual tabs to learn more about how your “On Study” research communications can be improved through plain language, numeracy, clear design and cultural considerations.
During the “On Study” stage the use of plain language continues to be important. Even though study participants may be more experienced at this stage, plain language terminology that was introduced earlier in the clinical trial should still be used to maintain continuity, comprehension of, and trust in the study and research team.
Protocol non-adherence, missed visits, and loss-to-follow-up can impact the validity of the research results. Plain language communications to help mitigate these issues include:
- reminders about the importance of the study question and the value of the participant’s continued research contributions,
- additional explanations about specific study procedures,
- in depth inquiries into what might prevent a participant from fulfilling the study requirements and discussing ways that the clinical research team may be able to help,
- expressing gratitude for what participants have provided to date.
During the “On Study” stage it is possible to continue building upon whatever resources were provided during recruitment and consent to re-affirm participant understanding of the details of the study. Health literate communications can be used to remind participants of the:
- frequency of study visits and procedures,
- study medication instructions (including review of tools such as study medication logs and study drug reconciliation procedures),
- the nature and probability of risks.
During the “On Study” stage clear design techniques can be applied to print materials to support a participant’s continued engagement in the study.
All tools and resources (such as health literate study calendars, study medication instructions, and study procedure descriptions), as well as additional materials like a regular study newsletter or results report should be laid-out in ways that are easy to review and understand.
During the “On Study” stage the concept of cultural can be addressed through an active inquiry into why participants may wish to continue or to decline ongoing participation in the study.
- Additional efforts for more difficult to reach populations may be required, particularly if logistical barriers to participation are identified.
- A study satisfaction survey administered when participants have had some experience in the study may permit the clinical research team to identify opportunities for improvement and may minimize the risk of participants not completing the study.
- Holiday and birthday cards that include a message of appreciation for participants’ contributions can help keep participants interested and feeling that they are valued.