Shared decision making with schizophrenic patients: a randomized controlled clinical trial with booster sessions (DECIDE Study).

BACKGROUND: The treatment of schizophrenia requires a prolonged, multidimensional intervention that includes antipsychotic drugs. Treatment adherence is essential to effectively control the disorder. Shared decision-making (SDM) is a strategy, supported by numerous practical and ethical arguments, that seeks to involve patients in the therapeutic process to improve treatment adherence and satisfaction. The use of this model in mental health has been limited for many intrinsic and extrinsic reasons. The results of clinical trials conducted to date have largely been disappointing, potential due to study design-related limitations. AIM/QUESTION: To evaluate the efficacy, in terms of treatment adherence and improvement in clinical variables, such as severity of symptoms, days of hospitalization or insight, of a carefully timed SDM model initiated immediately prior to hospital discharge in patients with schizophrenia. METHODS: Single-blind, randomized clinical trial in an acute psychiatric care unit within the Andalusian Health Department to compare SDM (experimental group) to treatment as usual (TAU; control group) in a sample of patients hospitalized for an acute episode of schizophrenia or schizoaffective disorder. The study was performed between January 2014 and June 2017. The experimental group participated in SDM sessions prior to discharge with regular booster sessions over the one-year follow-up. The health care team responsible for SDM was predisposed to concordance (LatCon II scale) and received specific training in SDM. A hierarchical multiple linear regression analysis was performed to evaluate the factors independently associated with adherence, controlling for sociodemographic, clinical, and admission-related variables. Variables were assessed at admission, discharge and at 3, 6 and 12 months after discharge during the one year follow up. BARS, DAI, WAI-S, COMRADE and PANSS were used to evaluate adherence, attitude to treatment, therapeutic alliance, satisfaction and confidence with decision and clinical status, respectively. RESULTS: A total of 227 schizophrenic patients hospitalized with acute decompensation were evaluated; of these, 102 met all inclusion criteria and were included in the study. Most patients (95%) had prior experience with antipsychotics and most (82%) had experienced related side effects. Despite randomization, psychopathologic severity was greater in the experimental group, with a mean (SD) PANSS score of 104.08 (80) vs. 93.45 (20.30) (p < 0.05). The final regression model to explain adherence was significant (adjusted R2 = 0.384; F [df= 6] = 4.386; p < 0.001), with a direct, significant and independent association with SDM mediated by the number of booster sessions. DISCUSSION: Shared decision making with booster sessions appears to increase treatment adherence in patients with severe mental disorders. IMPLICATION ON PRACTICE: Ethical, practical, and clinical reasons support the use of strategies designed promote the use of long-term, shared decision-making in psychiatric patients, especially in schizophrenia spectrum disorder.

Factors associated with the use of mechanical restraint in a mental health hospitalization unit: 8-year retrospective analysis.

WHAT IS ALREADY KNOWN ABOUT THE TOPIC?: Our present understanding of mechanical restraint is heterogenous, largely due to the important differences between countries/regions. In Spain, the use of this restrictive practice is not regulated, nor is its use protocolized. Previous studies that have investigated the impact of organizational factors and changes in these protocols are often short and not conducted within a framework designed to establish a long-term plan for reducing the use of mechanical restraint. WHAT THIS PAPER ADDS TO EXISTING KNOWLEDGE?: We demonstrate that the implementation of administrative and protocol changes in our psychiatric unit significantly reduced the use of mechanical restraint, thus laying the foundations for a regulatory framework. Our analysis shows that the profile of patients who require mechanical restraint is highly variable, but that certain clinical and institutional aspects within the framework of a long-term plan for the reduction in mechanical restraint can be targeted with long-lasting positive effects. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Organizational changes focussed on training staff, promoting family support and requiring the registration and close monitoring of episodes empower the role of the nursing staff in the prevention, monitoring and regulation of mechanical restraint. ABSTRACT: Introduction Mechanical restraint is a controversial restrictive practice to manage agitation or violent behaviour. Numerous studies have evaluated the factors and organizational changes that influence on mechanical restraint, but only for short time periods. None of those studies have assessed the effects of measures applied within the framework of a long-term plan to reduce the use of mechanical restraint. Given the lack of specific legislation in Spain, more data are required for its proper regulation. Aim/Question To evaluate the risk factors associated and the impact of specific measures designed to minimize the application of mechanical restraint in an acute mental health unit over an 8-year period and previous observation of 5 years. Methods Cross-sectional study based on a retrospective analysis of mechanical restraint records. We compared admissions requiring ≥one episode of restraint versus admissions not requiring this coercive measure. Results Between 2007 and 2014, 412 admissions (12%) required mechanical restraint. The data show that the measures applied in the previous five years had significantly reduced the total hours of restraint per semester. The factors associated with admissions requiring mechanical restraint were involuntary, unscheduled and longer admissions. The best predictor of restraint was involuntary admission (OR = 6.37), followed by the diagnosis of personality disorder (OR = 5.01). Discussion Identification of the factors associated with mechanical restraint would allow for early detection strategies. Our results provide additional evidence on the usefulness of organizational changes to reduce coercive measures, even in a country without specific legislation. Implications for Practice Organizational changes, such as staff training and increased family support during admission of episodes of mechanical restraint, can reduce the use of this measure. These measures also give the nursing staff greater responsibility in terms of their role in registering and monitoring the restrictive practice, thus helping to prevent or minimize the use of mechanical restraint.