Table 1 Primary and secondary outcomes and measures
| Â | Outcomes | Timepoint(s) of evaluation of outcome measures |
|---|---|---|
Primary | •Recruitment •Retention | •Recruitment at 0 week: % of those eligible and approached who consent to randomisation at invitation •Retention at 4–8 weeks: % completing follow-up questionnaire 4–8 weeks after baseline questionnaire |
Secondary | •Size of the eligible participant population •Participant and healthcare professional adherence to the intervention/trial •Fidelity of delivery of the intervention •Acceptability of the intervention and trial methods •Barriers and facilitators to intervention implementation in different settings •Estimates of the effect of the intervention on possible mediators of the intervention •Assessing linkage to UKRR data regarding planned outcome for later main trial (receipt of a LDKT) •Impact on existing healthcare delivery and potential for the intervention to become a normalised part of everyday care •Cost drivers | •Size of the eligible population screening at − 4 to 0 weeks •Adherence to intervention/trial and fidelity of delivery of the intervention assessed at 4–8 weeks — % of participants in intervention arm who receive the various intervention components; number of letters sent to potential donors per participant in intervention arm; % of participants who complete questionnaires at baseline and 4–8 weeks after baseline; number of protocol deviations reported; observed fidelity of intervention delivery •Acceptability of intervention and trial methods at 10 weeks — assessed through qualitative interviews •Barriers and facilitators to recruitment — measured by time to green light at each site and time to recruitment of first participant, assessment of screening log and qualitative interviews with participants, nonparticipants and healthcare professionals •Estimates of the effect of the intervention on possible mediators of the intervention at 4–8 weeks — measured through questionnaires measuring patient activation, social support, LDKT knowledge and health literacy at baseline and 4—8 weeks later • Assessing linkage to UKRR data regarding planned outcome for later main trial (receipt of a LDKT), assessed after closure of trial recruitment •Impact on existing healthcare delivery measured through qualitative interviews with HCPs after 3 months of study being active at study site • Cost drivers measured at feasibility trial completion |