| Allocation: randomised, with sequence generation and concealment of allocation clearly described.
Blindness: single.
Design: parallel group.
Duration: 1, 12 and greater than 12 hours. |
Diagnosis: any person admitted to a mental health facility, at any stage of illness, displaying aggressive, violent or self harming behaviour.
N=300.*
Age: any.
Sex: both. |
1. Observation levels ‐ e.g. 15 min vs 30 min.
2. Locked wards ‐ e.g. open vs closed environment.
3. De‐escalation techniques ‐ e.g. one technique vs another.
4. Staffing levels ‐ e.g. high vs not high.
5. Prescribing ‐ e.g. nurse prescribing + prescribing by doctor vs doctor prescribing alone.
6. Use of behavioural contracts ‐ e.g. contract (agreements) vs no contract. |
Death: suicide or natural causes.
Harm ‐ to self or others.**
Acceptability of treatment to patient, staff and carers (binary outcome).
Clinical response (CGI ‐ binary).
Serious adverse effects (list).
Service use (nursing hours).
Economic outcomes. |
* Size of study with sufficient power to highlight ˜10% difference between groups for primary outcome.
** Primary outcome. |
