Table 2 Progression criteria for RCT
Domain | Proceed with RCT (green light) | Do not proceed (red light) |
|---|---|---|
Recruitment | ≥ 25% of eligible participants consenting (or consultee agreeing) to feasibility study | < 10% of eligible participants consenting to feasibility study |
Completion of intervention | ≥ 70% participants attend ≥ 60% of sessions as planned | < 30% participants attend ≥ 60% of sessions as planned |
Retention | Retention of ≥ 60% of recruited participants for key outcome data at 6 months | Retention of < 50% of consented participants for provision of key outcome data at 6 months |
Intervention acceptability | Evidence from the process evaluation that the intervention can be delivered with fidelity and that it is acceptable to individuals with diverse characteristics | Evidence from the process evaluation that the intervention cannot be delivered with fidelity and that it is not acceptable to individuals with diverse characteristics |
Intermediate targets will be defined as amber and will be reviewed by the Programme Steering Committee and funder | ||