TREC-SAVE: a trial for aggressive or violent seriously mentally ill people
| ISRCTN | ISRCTN49454276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49454276 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr Gisele Huf
Scientific
Scientific
Av Brasil 4365 Manguinhos
Rio de Janeiro
21040-900
Brazil
| gisele.huf@incqs.fiocruz.br |
Study information
| Study design | Single-centre randomised open controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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) |
| Condition | 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 | Time to release from restraints or seclusion |
| Secondary outcome measures | 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 |
| Overall study start date | 16/06/2010 |
| Overall study end date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 100 people |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 16/06/2010 |
| Recruitment end date | 30/04/2011 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Av Brasil 4365 Manguinhos
Rio de Janeiro
21040-900
Brazil
21040-900
Brazil
Sponsor information
National Institute of Quality Control in Health (Brazil)
Government
Government
Av. Brasil 4365 Manguinhos
Rio de Janeiro
21040-900
Brazil
| Phone | +55(0) 21 3865 5112 |
|---|---|
| gisele.huf@incqs.fiocruz.br | |
| Website | http://www.incqs.fiocruz.br |
"ROR" |
https://ror.org/04jhswv08 |
Funders
Funder type
Research organisation
National Institute of Quality Control in Health - Oswaldo Cruz Foundation (Brazil)
No information available
Federal University of Rio de Janeiro (UFRJ) (Brazil) - School of medicine
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
