TREC-SAVE: a trial for aggressive or violent seriously mentally ill people

ISRCTN	ISRCTN49454276
DOI	https://doi.org/10.1186/ISRCTN49454276
Protocol serial number	N/A
Sponsor	National Institute of Quality Control in Health (Brazil)
Funders	National Institute of Quality Control in Health - Oswaldo Cruz Foundation (Brazil), Federal University of Rio de Janeiro (UFRJ) (Brazil) - School of medicine

Submission date: 14/12/2010
Registration date: 04/03/2011
Last edited: 28/07/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gisele Huf
Scientific

Av Brasil 4365 Manguinhos
Rio de Janeiro
21040-900
Brazil

Email	gisele.huf@incqs.fiocruz.br

Study information

Primary study design	Interventional
Study design	Single-centre randomised open controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial comparing mechanical restraints with seclusion for aggressive mentally ill people in emergency psychiatric hospitals
Study acronym	TREC-SAVE
Study objectives	The trial aims to test the hypothesis that one procedure (seclusion or restraints) is more effective and/or more safe for the management of agitated and violent people in emergency psychiatric hospitals.
Ethics approval(s)	Ethics Committee from Philippe Pinel Institute in Rio de Janeiro approved on the 24th February 2010 (ref: 56/2010)
Health condition(s) or problem(s) studied	Aggressive/violent mental illness
Intervention	1. Use of four point physical restraint (cotton bands) and policy of close recording of mental state, behaviour, wellbeing, in addition to standard use of medication. 2. Use of secure seclusion room and policy of close recording of mental state, behaviour, wellbeing, in addition to standard use of medication. In the case of Instituto Philippe Pinel secure seclusion involves a locked room with minimal bedding but airy and with good day light though barred windows with no frame or glass open to the nursing station or passing patients. The total duration of each intervention is exactly the primary outcome, but follow-up in each arm will last by two weeks.
Intervention type	Other
Primary outcome measure(s)	Time to release from restraints or seclusion
Key secondary outcome measure(s)	1. Safe resolution of episode, measured 24 hours after the beginning of the episode 2. Time in restriction, measured 24 hours after the beginning of the episode 3. Further episode, measured 24 hours after the beginning of the episode 4. Need to call the doctor on an emergency basis, measured 24 hours after the beginning of the episode 5. Refusal of oral medication, measured 24 hours after the beginning of the episode 6. Amount of medication and how administered, measured 24 hours after the beginning of the episode 7. Acceptability to patient/staff, measured 24 hours after the beginning of the episode 8. Adverse effects, measured at 2 weeks 9. Time to discharge, measured at 2 weeks
Completion date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	16/06/2010
Date of final enrolment	30/04/2011

Locations

Countries of recruitment

Brazil

Study participating centre

Av Brasil 4365 Manguinhos

Rio de Janeiro
21040-900
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	20/07/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes