TREC-SAVE: a trial for aggressive or violent seriously mentally ill people
Completed
- Conditions
- Aggressive/violent mental illnessMental and Behavioural Disorders
- Registration Number
- ISRCTN49454276
- Lead Sponsor
- ational Institute of Quality Control in Health (Brazil)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. Anyone (no age or gender limits) thought to have a serious mental illness admitted to the hospital who has a degree or risk of aggression or violent behaviour that endangers themselves or others
2. Who is thought by medical and nursing staff to need some form of physical restriction
3. For whom the medical and nursing staff have doubt as to whether one form of restriction is better than the other
Exclusion Criteria
1. Anyone for whom either or both packages of care are contraindicated by either medical or nursing staff
2. Anyone already randomised in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to release from restraints or seclusion
- Secondary Outcome Measures
Name Time Method 1. Safe resolution of episode, measured 24 hours after the beginning of the episode<br>2. Time in restriction, measured 24 hours after the beginning of the episode<br>3. Further episode, measured 24 hours after the beginning of the episode<br>4. Need to call the doctor on an emergency basis, measured 24 hours after the beginning of the episode<br>5. Refusal of oral medication, measured 24 hours after the beginning of the episode<br>6. Amount of medication and how administered, measured 24 hours after the beginning of the episode<br>7. Acceptability to patient/staff, measured 24 hours after the beginning of the episode<br>8. Adverse effects, measured at 2 weeks<br>9. Time to discharge, measured at 2 weeks