Stepped-Wedge Trial

All hospitals begin in the control phase and provide usual care before switching phases. The stepped-wedge design was chosen because feasibility testing suggested a traditional cluster randomised trial would require more than 40 hospitals…

2 sources - 12 claims

All hospitals begin in the control phase and provide usual care before switching phases. The stepped-wedge design was chosen because feasibility testing suggested a traditional cluster randomised trial would require more than 40 hospitals and be difficult to achieve. Randomisation and blinding are not employed due to the ethical and practical constraints of Aboriginal health research, which require community benefit, governance, transparency, and accountability. The trial plans to recruit up to 24 hospitals in England, including 20 active hospitals and four reserve hospitals. Every three months, five hospitals are randomised to enter the intervention implementation phase. Each hospital has a three-month implementation phase before entering the active intervention phase. The 12-week duration of the remission phase was informed by existing research on habit formation. The study is a 28-week non-randomised stepped-wedge pilot trial with two sites and three clusters in rural South Australia. As a pilot study, inferential statistical tests and power calculations are not applicable; analysis is primarily descriptive. Each participant progresses through three phases — control, remission,…