Dataset Information

TREC-SAVE: a randomised trial comparing mechanical restraints with use of seclusion for aggressive or violent seriously mentally ill people: study protocol for a randomised controlled trial.

ABSTRACT:

Background

Thousands of people whose aggression is thought due to serious mental illness are secluded or restrained every day. Without fair testing these techniques will continue to be used outside of a rigorous evidence base. With such coercive treatment this leaves all concerned vulnerable to abuse and criticism. This paper presents the protocol for a randomised trial comparing seclusion with restraints for people with serious mental illnesses.

Methods/design

Setting-General psychiatric wards of a large psychiatric hospital in Rio de Janeiro, Brazil. Participants-Anyone aggressive or violent suspected or known to have serious mental illness for whom restriction is felt to be indicated by nursing and medical staff, but also for whom they are unsure whether seclusion or restraint would be indicated. Interventions-The standard care of either strong cotton banding to edge of bed with medications as indicated and close observation or the other standard care of use of a minimally furnished seclusion room but with open but barred windows onto the nursing station. Outcomes-time to restrictions lifted, early change of treatment, additional episodes, adverse effects/events, satisfaction with care during episode. Duration-2 weeks. Identifier: ISRCTN 49454276 http://www.controlled-trials.com/ISRCTN49454276.

SUBMITTER: Huf G

PROVIDER: S-EPMC3154155 | biostudies-literature | 2011 Jul

REPOSITORIES: biostudies-literature

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Publications

TREC-SAVE: a randomised trial comparing mechanical restraints with use of seclusion for aggressive or violent seriously mentally ill people: study protocol for a randomised controlled trial.

Huf Gisele G Coutinho Evandro S F ES Ferreira Marco A V MA Ferreira Silvana S Mello Flavia F Adams Clive E CE

Trials 20110720

<h4>Background</h4>Thousands of people whose aggression is thought due to serious mental illness are secluded or restrained every day. Without fair testing these techniques will continue to be used outside of a rigorous evidence base. With such coercive treatment this leaves all concerned vulnerable to abuse and criticism. This paper presents the protocol for a randomised trial comparing seclusion with restraints for people with serious mental illnesses.<h4>Methods/design</h4>Setting-General psy ...[more]

PMID: 21774823

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Project description:ObjectivesTo examine the association between the quality of care delivered to nursing home residents with and without a serious mental illness (SMI) and the proportion of nursing home residents with SMI.DesignInstrumental variable study. Relative distance to the nearest nursing home with a high proportion of SMI residents was used to account for potential selection of patients between high- and low-SMI facilities. Data were obtained from the 2006-2010 Minimum Data Set assessments linked with Medicare claims and nursing home information from the Online Survey, Certification, and Reporting database.SettingNursing homes with high (defined as at least 10% of a facility's population having an SMI diagnosis) and low proportions of SMI residents.ParticipantsA total of 58 571 Medicare nursing residents with an SMI diagnosis (ie, schizophrenia or bipolar disorder) and 558 699 individuals without an SMI diagnosis who were admitted to the same nursing homes.MeasurementsOutcomes were nursing home quality measures: (1) use of physical restraints, (2) any hospitalization in the last 3 months, (3) use of an indwelling catheter, (4) use of a feeding tube, and (5) presence of pressure ulcer(s).ResultsFor individuals with SMI, admission to a high-SMI facility was associated with a 3.7 percentage point (95% confidence interval [CI] = 1.4-6.0) increase in the probability of feeding tube use relative to individuals admitted to a low-SMI facility. Among individuals without SMI, admission to a high-SMI facility was associated with a 1.7 percentage point increase in the probability of catheter use (95 CI = .03-3.47), a 3.8 percentage point increase in the probability of being hospitalized (95% CI = 2.16-5.44), and a 2.1 percentage point increase in the probability of having a feeding tube (95% CI = .43-3.74).ConclusionAdmission to nursing homes with high concentrations of residents with SMI is associated with worse outcomes for both residents with and without SMI. J Am Geriatr Soc 67:2346-2352, 2019.

Project description:IntroductionAs many as 74% of veterans with alcohol use disorders (AUDS) report symptoms of insomnia. Insomnia represents a barrier to alcohol treatment because insomnia symptoms (1) may lead to relapse among those who use alcohol to help them sleep and may negatively impact (2) executive functions and (3) emotion regulation skills. Cognitive-behavioural therapy for insomnia (CBT-I) is an efficacious first-line treatment for insomnia; however, no research has examined the impact of CBT-I on individuals' response to alcohol treatment. In the Sleep and Alcohol for Veterans (Project SAVE) randomised controlled trial, we hypothesise that CBT-I will enhance the efficacy of alcohol treatment among Veterans with insomnia by enhancing their abilities to attend to treatment, regulate emotions and initiate sleep without alcohol.Methods and analysisEighty Veterans enrolled in alcohol treatment at the Veterans Administration (VA) hospital will be randomly assigned to receive either CBT-I or single-session sleep hygiene (SH) education. Individuals will be eligible to participate if they meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for moderate to severe AUD and Insomnia Disorder of at least 1-month duration. Participants will complete assessments at baseline, post-treatment and 6-week follow-up. Preliminary process outcomes include retention/recruitment rates and treatment satisfaction (feasibility and acceptability, respectively). Primary outcomes are insomnia severity, percentage of heavy-drinking days and alcohol-related problems. We will assess a variety of secondary clinical and mechanistic outcomes (eg, post-traumatic stress disorder (PTSD) symptoms, attention and working memory).Ethics and disseminationEthics approval was obtained in October 2018. Data collection began in July 2019 and is planned for completion by July 2021. Trial results will be disseminated at local and national conferences, in peer-reviewed publications and through media outlets, as available. Results will also be shared with interested participants and clinical collaborators at the end of the trial.Trial registration numberclinicaltrials.gov identifier NCT03806491 (pre-results).

Project description:Background: Acute psychiatric units in general hospitals must ensure that acutely disturbed patients do not harm themselves or others, and simultaneously provide care and treatment and help patients regain control of their behavior. This led to the development of strategies for the seclusion of a patient in this state within a particular area separated from other patients in the ward. While versions of this practice have been used in different countries and settings, a systematic framework for describing the various parameters and types of seclusion interventions has not been available. The aims of the project were to develop and test a valid and reliable checklist for characterizing seclusion in inpatient psychiatric care. Methods: Development and testing of the checklist were accomplished in five stages. Staff in psychiatric units completed detailed descriptions of seclusion episodes. Elements of seclusion were identified by thematic analysis of this material, and consensus regarding these elements was achieved through a Delphi process comprising two rounds. Good content validity was ensured through the sample of seclusion episodes and the representative participants in the Delphi process. The first draft of the checklist was revised based on testing by clinicians assessing seclusion episodes. The revised checklist with six reasons for and 10 elements of seclusion was tested with different response scales, and acceptable interrater reliability was achieved. Results: The Clinical Seclusion Checklist is a brief and feasible tool measuring six reasons for seclusion, 10 elements of seclusion, and four contextual factors. It was developed through a transparent process and exhibited good content validity and acceptable interrater reliability. Conclusion: The checklist is a step toward achieving valid and clinically relevant measurements of seclusion. Its use in psychiatric units may contribute to quality assurance, more reliable statistics and comparisons across sites and periods, improved research on patients' experiences of seclusion and its effects, reduction of negative consequences of seclusion, and improvement of psychiatric intensive care.

Project description:BACKGROUND:Physical restraints such as bedrails and belts are regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomised controlled trial, the efficacy and safety of a guideline-based multicomponent intervention programme has been proven. The present study aims to evaluate the effectiveness of two different versions of the original intervention in nursing home residents in four different regions throughout Germany. METHODS/DESIGN:The study is a pragmatic cluster-randomised controlled trial comparing two intervention groups, i.e. (1) the updated original multicomponent intervention programme and (2) the concise version of the updated programme, with a control group receiving optimised usual care. The first intervention group receives an educational programme for all nurses, additional training and structured support for nominated key nurses, printed study material and other supportive material. In the second intervention group, nurses do not receive education as part of the intervention, but may be trained by nominated key nurses who have received a short train-the-trainer module. All other components are similar to the first intervention group. The control group receives the printed study material only. Overall, 120 nursing homes including approximately 10,800 residents will be recruited and randomly assigned to one of the three groups. The primary outcome is defined as the proportion of residents with at least one physical restraint after 12 months follow-up. The use of physical restraints will be assessed by direct observation. Secondary outcomes are the residents' quality of life and safety parameters, e.g. falls and fall-related fractures. In addition, comprehensive process and economic evaluations will be performed. CONCLUSIONS:We expect a clinically relevant reduction in the proportion of residents with physical restraints. It is also expected that the process outcomes of this trial will enrich the knowledge about facilitators and barriers for the implementation of the multicomponent intervention programme. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02341898.

Dataset Information

TREC-SAVE: a randomised trial comparing mechanical restraints with use of seclusion for aggressive or violent seriously mentally ill people: study protocol for a randomised controlled trial.

Background

Methods/design

Publications

TREC-SAVE: a randomised trial comparing mechanical restraints with use of seclusion for aggressive or violent seriously mentally ill people: study protocol for a randomised controlled trial.

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