WORK PACKAGE 4 – DEFINITIVE TRIAL

Internal pilot and definitive cluster Randomised Control Trial (June 2022- September 2024).

We will carry out the definitive trial of the CHARMER intervention across up to 42 hospitals. We will assess the CHARMER intervention in terms of safety, effectiveness and cost effectiveness. We will also develop recommendations about the CHARMER intervention process and characteristics to help people implement it in the future. We will use processes developed and refined from Work Package 3 (the feasibility trial) to inform all Work Package 4 procedures.

PATIENT AND PUBLIC INVOLVEMENT

Patient and public involvement in this stage of the research will involve collaborating with work package leads to design patient participant materials and involvement in analysis of qualitative data to provide transparency and validation of interpretations.