Show results to participants engaged in clinical trials

INTERVENTION: In Show RESPECT, ICON8 sites will be randomised using 2 by 2 by 2 factorial cluster randomisation. Therefore there will be 8 possible intervention combinations. The interventions within the study are: 1. Basic webpage vs enhanced webpage 2. No printed summary vs printed summary posted to participant 3. No email list invitation vs invitation to join email list To randomise sites, we shall generate a randomisation sequence within each volume stratum based on randomly permuted blocks of size 8 (no surplus stratum is used in this scenario). Once many sites have approvals in place, and the rate of further approvals being obtained has slowed, then we would randomise all sites with approvals in place. We would apply the randomisation sequence to sites after randomly permuting them within each stratum in Stata software. We anticipate conducting this initial randomisation for all three strata at the same time. However in the event that approvals accumulate quickly in some strata but not in others, and in particular if in one or more strata fewer than 8 sites are ready to be randomised, we may perform the initial randomisation for some strata earlier than for others. After the initial randomisation for each stratum, as further sites obtain approvals we shall allocate them in real time to the next allocation in the sequence. Link to the Basic Webpage: Participants randomised to receive a link to a basic webpage will be given the URL of a webpage in their Patient Update Information Sheet. It will be up to participants as to whether they access it. Each site randomised to this will be given a different URL (pointing to the same page), to allow us to monitor uptake by site, as well as overall number of hits. The information on the page will follow the structure and ‘friendly’ versions of the headings for lay summaries mandated by the European Parliam CONDITION: Communicating trial results to participants ; Not Applicable PRIMARY OUTCOME: The primary outcome measure is participant’s satisfaction with the way they found out the results of ICON8, measured using a 5‐point Likert scale one month after receiving the intervention. SECONDARY OUTCOME: ; 1. The extent of participant’s agreement with the statement ‘the information about the trial results told me everything I wanted to know’, measured using a 5‐point Likert scale one month after receiving the intervention.; 2. Participants’ Ease of understanding of the results, measured using a 5‐point Likert scale one month after receiving the intervention.; 3. How upsetting participants found the results, measured using a 5‐point Likert scale one month after receiving the intervention.; 4. Participants’ willingness to take part in another trial in the future, measured using a 5‐point Likert scale one month after receiving the intervention.; 5. Participants’ likelihood of recommending taking part in a clinical trial to friends and family, measured using a 5‐point Likert scale one month after receiving the intervention.; 6. How glad participants are to have found out the results, measured using a 5‐point Likert scale one month after receiving the intervention.; 7. Participants’ regret at finding out the results, measured using a 5‐point Likert scale one month after receiving the intervention.; 8. Reported uptake of the interventions offered, measured using self‐report via a questionnaire one month after receiving the intervention.; 9. Proportion of participants who reported wanting to find out the results but not having done so, measured using a questionnaire one month after receiving the intervention.; 10. Proportion of participants who reported not wanting to find out the results who did find out the results, measured using a questionnaire one month after receiving the intervention.; 11. Participants’ reported ease of finding out the results, measured using a 5‐point Likert scale one month after receiving the intervention.; 12. Other ways participants would have liked to receive the result, measured using free‐text question in a questionnaire one month after receiving the intervention.; 13. Participants preferred way to receive the results, measured using a multiple choice question one month after receiving the interventions.; 14. Site staff’s concerns about the interventions or process, measured using a free‐text question in a questionnaire immediately after delivering the intervention(s) and 2‐3 months after delivering the intervention(s).; 15. Site staff’s time spent delivering the interventions, measured using multiple choice questions in a questionnaire immediately after delivering the intervention.; 16. Role of staff involved in delivering the interventions, measured using a multiple choice question in a questionnaire immediately after delivering the intervention.; 17. Challenges in implementing the interventions reported by site staff, measured using a free‐text question in a questionnaire immediately after delivering the intervention(s) and 2‐3 months after delivering the intervention(s).; 18. Number of queries received from patients by site staff relating to the ICON8 results, measured using a questionnaire 2‐3 months after delivering the intervention.; 19. Costs incurred by the site in implementing the intervention, measured using a free‐text question in a questionnaire immediately after delivering the intervention.; 20. Site staff’s views on what they would like to do differently for the next trial they are involved in communicating the results for, measured using a free‐text question in a questionnaire immediately after delivering the intervention(s) and 2‐3 months after delivering the intervention(s).; 21. Proportion of patients the Patient Update Information Sheet is distributed to, measured in a log completed by staff at time of distribution of Patient Update Information Sheets.; 22. Proportion of patients at sites randomised to distributed a printed summary who were sent the printed summary, measured in a log completed by staff at time of distribution of the printed summary.; 23. Proportion of patients at sites randomised to distributed a printed summary who opt out of receiving the printed summary, measured in a log completed by staff at time of distribution of the printed summary.; 24. Site staff’s preferred method of communicating results to participants, measured via a multiple choice question in a questionnaire immediately after delivering the intervention(s) and 2‐3 months after delivering the intervention(s).; 25. Site staff’s views on whether the interventions they were allocated to should become standard practice, measured via a multiple choice question in a questionnaire immediately after delivering the intervention(s) and 2‐3 months after delivering the intervention(s).; 26. CTU staff’s reported concerns about the process of communicating results to participants, measured via a free text question in a questionnaire immediately after the first sites deliver the interventions and 2‐3 months after the last site delivers the interventions.; 27. Time taken by CTU staff to implement the interventions, measured via a categorical question in a questionnaire immediately after the first sites deliver the interventions and 2‐3 months after the last site delivers the interventions.; 28. CTU staff’s views on challenges faced implementing the intervention, measured via a free text question in a questionnaire 2‐3 months after the last site delivers the interventions.; 29. Number of queries received by CTU staff from participants or sites about the interventions or results, measured via numerical questions in a questionnaire 2‐3 months after the last site delivers the interventions.; 30. Costs incurred by the CTU in implementing the interventions, measured via an expenditure tracker completed during the course of the study, as expenditures occur.; 31. CTU staff’s views on what they would like to do different for the next trial they are involved in communicating the results of, measured via a free text question in a questionnaire 2‐3 months after the last site delivers the interventions.; 32. Uptake of the basic and enhanced webpages, by site, measured via analytics data from site‐specific links, at one, two and three months after the Patient Update Information Sheet is distributed.; 33. Number of sign‐ups to the email list, measured via email list data monthly after the first set of Patient Update Information Sheets are distributed until the end of September 2019.; 34. CTU staff’s preferred method of communicating the results to participants, measured via a multiple choice question in a questionnaire 2‐3 months after the last site delivers the interventions.; 35. CTU staff’s reported concerns about the process of communicating results to participants, measured via a free text question in a questionnaire 2‐3 months after the last site delivers the interventions.; 36. CTU staff’s reported views on whether they would prefer to have given participants a different way to find out the results, measured via a free text question in a questionnaire 2‐3 months after the last site delivers the interventions.; INCLUSION CRITERIA: 1. Participant in the ICON8 trial 2. Currently being followed up at an ICON8 trial site in England, Scotland, Wales and Northern Ireland 2.1. Including those with reduced follow‐up arrangements 3. Aged 18 years or older