| Red (discuss with Oversight Committee and consider substantial changes before proceeding to the definitive trial) | Amber (discuss with Oversight Committee strategies for improvement and consider changes to processes before deciding whether to proceed to full trial) | Green (go ahead) |
---|---|---|---|
Recruitment | |||
Proportion of PEH (as assessed by the researchers) meeting eligibility criteria and agreeing to participate |  < 40% | 40–50% |  > 50% |
Retention | |||
Proportion of participants remaining in the study at 6 months |  < 50% | 50–60% |  > 60% |
Intervention adherence | |||
Proportion of participants attending > 50% of intervention visits as planned (flexible schedule agreed at consultation) |  < 50% | 50–60% |  > 60% |
Outcome data | |||
Proportion of participants with Emergency Department visits and mortality data available at 6 months |  < 60% | 60–70% |  > 70% |
Proportion of patients with questionnaire booklets completed at 6 months |  < 50% | 50–60% |  > 60% |