A comparison of standard occupational therapy versus early enhanced occupation-based therapy in a medical/surgical intensive care unit: study protocol for a single site feasibility trial (EFFORT-ICU)

Table 1 Progression criteria for RCT

Domain	Proceed with RCT	Proceed with changes to protocol	Do not proceed unless problem resolution
Recruitment	Recruitment of 30 eligible patients within 6 months	Recruitment of eligible patients within 6–12 months	Unable to recruit 30 patients in 12 months
Retention	Minimum of 75% retention to follow-up	Minimum of 50 % retention to follow-up	Less than 50% retention to follow-up
Completion of intervention	At least 50% complete intervention for 40–60 min per day	At least 50% complete intervention for 20–40 min per day	Less than 50% complete intervention for 20 min per day
Outcome measures acceptability	Able to administer 80% of the outcome measures at each time point	Able to administer 80% of the outcome measures at each time point	Able to administer 80% of the outcome measures at each time point
Adverse events	No serious therapy-related adverse events during trial	Less than 5 serious therapy-related adverse events during trial	Five or more serious therapy-related adverse events during trial

ISSN: 2055-5784