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Background: In 2014, nursing home administration and government officials were facing increasing public and media scrutiny around the variation of antipsychotic medication (APM) prescribing across Ontario nursing homes. In response, policy makers partnered to test an academic detailing (AD) intervention to address appropriate prescribing of APM in nursing homes in a cluster-randomized trial. This mixed-methods study aimed to explore how and why the AD intervention may have resulted in changes in the nursing home context. The objectives were to understand how the intervention was implemented, explore contextual factors associated with implementation, and examine impact of the intervention on prescribing.Methods: Administrative data for the primary outcome of the full randomized trial will not be available for a minimum of 1 year. Therefore, this paper reports the findings of a planned, quantitative interim trial analysis assessed mean APM dose and prescribing prevalence at baseline and 3 and 6 months across 40 nursing homes (18 intervention, 22 control). Patient-level administrative data regarding prescribing were analyzed using generalized linear mixed effects regression. Semi-structured interviews were conducted with nursing home staff from the intervention group to explore opinions and experiences of the AD intervention. Interviews were analyzed using the framework method, with constructs from the Consolidated Framework for Implementation Research (CFIR) applied as pre-defined deductive codes. Open coding was applied when emerging themes did not align with CFIR constructs. Qualitative and quantitative findings were triangulated to examine points of divergence to understand how the intervention may work and to identify areas for future opportunities and areas for improvement.Results: No significant differences were observed in prescribing outcomes. A total of 22 interviews were conducted, including four academic detailers and 18 nursing home staff. Constructs within the CFIR domains of Outer Setting, Inner Setting, and Characteristics of Individuals presented barriers to antipsychotic prescribing. Intervention Source, Evidence Strength and Quality, and Adaptability explained participant engagement in the AD intervention; nursing homes that exhibited a Tension for Change and Leadership Engagement reported positive changes in processes and communication.Conclusions: Participants described their experiences with the intervention against the backdrop of a range of factors that influence APM prescribing in nursing homes that exist at the system, facility, provider, and resident levels. In this context, the perceived credibility and flexibility of the intervention were critical features that explained engagement with and potential impact of the intervention. Development of a common language across the team to enable communication was reported as a proximal outcome that may eventually have an effect on APM prescribing rates. Process evaluations may be useful during early stages of evaluation to understand how the intervention is working and how it might work better. Qualitative results suggest the lack of early changes observed in prescribing may reflect the number of upstream factors that need to change for APM rates to decrease.Trial Registration: ClinicalTrials.gov, NCT02604056. [ABSTRACT FROM AUTHOR]

Background: 80% of patients value information on treatment options as an important part of recovery, further patients with a history of psychotic episodes feel excluded from decision making about their antipsychotic treatment, and on top of that, mental health staff is prone to be reluctant to support shared decision making and medication tapering for patients with schizophrenia. This case series aims to demonstrate the tapering of antipsychotic medication and how guided tapering affects the patient's feeling of autonomy and psychiatric rehabilitation. Case presentation: We present six patients diagnosed with schizophrenia (International Classification of Mental and Behavioral Disorders– 10th Edition codes F20.0–5, F20.7–9) who underwent professionally guided tapering in our clinic. The clinic aims to guide the patients to identify the lowest possible dose of antipsychotic medication in a safe setting to minimise the risk of severe relapse. Two patients completely discontinued their antipsychotic medication, two suffered a relapse during tapering, one chose to stop the tapering at a low dose, and one patient with treatment resistant schizophrenia, which is still tapering down. Conclusions: Reducing the antipsychotic dose increased emotional awareness in some patients (n = 4) helping them to develop better strategies to handle stress and increased feelings of recovery. Patients felt a greater sense of autonomy and empowerment during the tapering process, even when discontinuation was not possible. Increased awareness in patients and early intervention during relapse may prevent severe relapse. Impact and implications: Some patients with schizophrenia might be over medicated, leading to unwanted side effects and the wish to reduce their medication. The patients in our study illustrate how guided tapering of antipsychotic medication done jointly with the patient can lead to improved emotional awareness and the development of effective symptom management strategies. This may in turn lead to a greater sense of empowerment and identity and give life more meaning, supporting the experience of personal recovery. [ABSTRACT FROM AUTHOR]

Background: More than half of people who use antipsychotic medication for psychosis report having sexual dysfunction. The REMEDY trial aimed to find out if switching antipsychotic medication provides an effective way to reduce sexual dysfunction among people with psychosis. We set out to recruit 216 participants over a two-year period, but recruitment was stopped after an extended 12-month pilot phase, during which we recruited only 10 participants. As part of a nested process evaluation, we conducted qualitative interviews with front-line clinicians to examine barriers to recruitment to the trial. Methods: We developed a semi-structured interview schedule to explore staff views on factors that influenced whether they referred potential participants to the study. We interviewed a purposive sample of 51 staff from four National Health Service (NHS) Trusts in England, ensuring a range of different backgrounds, seniority, and levels of involvement in the trial. Audio recordings of interviews were transcribed for verbatim, and data were analysed using an inductive approach to thematic analysis. Results: Nine interconnected themes were generated. Six themes concerned barriers to recruitment; including; prioritising patients' mental stability, mutual discomfort and embarrassment about discussing a "taboo" subject, and concerns about unintended consequences of asking people with psychosis about their sexual functioning. Three themes, including the quality of treatment relationships and strategies for opening dialogue suggested ways to improve recognition of these "hidden" side effects. Conclusion: The identification and management of sexual dysfunction among people with psychosis are not priorities for mental health services in England at this time. Many staff working in front-line services feel unprepared and uncomfortable asking people with psychosis about these problems. While greater use of screening tools may improve the identification of sexual dysfunction among people with psychosis, the evaluation and implementation of interventions to manage them will continue to be challenging unless NHS leaders and senior clinicians demonstrate greater commitment to changing current clinical practice. Trial registration: Current Controlled Trials ISRCTN12307891. [ABSTRACT FROM AUTHOR]

Background: Cannabis use is an important risk factor for development of psychosis and further transition to schizophrenia. The prevalence of patients with psychosis and comorbid cannabis use (dual diagnosis) is rising with no approved specialized pharmacological treatment option. Cannabidiol, a constituent of the Cannabis sativa plant, has potential both as an antipsychotic and as a cannabis substituting agent. The aim of this study is to evaluate the efficacy of cannabidiol versus a first-choice second-generation antipsychotic (risperidone) in patients with early psychosis and comorbid cannabis use. Methods: The study is a phase II randomized, double-blinded, parallel-group, active-comparator clinical trial. We plan to include 130 patients aged between 18 and 64 years with a recent diagnosis of psychosis, comorbid cannabis use, and currently not treated with antipsychotics. The participants will be randomized to seven weeks of treatment with either cannabidiol 600 mg (300 mg BID) or risperidone 4 mg (2 mg BID). Participants will undergo clinical assessment after 1, 3, 5 and 7 weeks, telephone assessment the weeks in between, and a safety visit two weeks after end of treatment. The primary outcomes are cessation of cannabis use (self-reported) and psychotic symptom severity. The secondary outcomes include frequency and quantity of cannabis use, global illness severity, psychosocial functioning, subjective well-being, cognition, sleep, circadian rhythmicity, and metabolomics. Discussion: The results of this trial can potentially contribute with a new treatment paradigm for patients suffering from dual diagnosis. Trial registration: ClinicalTrials.gov, NCT04105231, registered April 23rd, 2021 [ABSTRACT FROM AUTHOR]

Background: Increasing number of service users diagnosed with schizophrenia and psychosis are being discharged from specialist secondary care services to primary care, many of whom are prescribed long-term antipsychotics. It is unclear if General Practitioners (GPs) have the confidence and experience to appropriately review and adjust doses of antipsychotic medication without secondary care support. Aim: To explore barriers and facilitators of conducting antipsychotic medication reviews in primary care for individuals with no specialist mental health input. Design & setting: Realist review in general practice settings. Method: A realist review has been conducted to synthesise evidence on antipsychotic medication reviews conducted in primary care with service users diagnosed with schizophrenia or psychosis. Following initial scoping searches and discussions with stakeholders, a systematic search and iterative secondary searches were conducted. Articles were systematically screened and analysed to develop a realist programme theory explaining the contexts (C) and mechanisms (M) which facilitate or prevent antipsychotic medication reviews (O) in primary care settings, and the potential outcomes of medication reviews. Results: Meaningful Antipsychotic medication reviews may not occur for individuals with only primary care medical input. Several, often mutually reinforcing, mechanisms have been identified as potential barriers to conducting such reviews, including low expectations of recovery for people with severe mental illness, a perceived lack of capability to understand and participate in medication reviews, linked with a lack of information shared in appointments between GPs and Service Users, perceived risk and uncertainty regarding antipsychotic medication and illness trajectory. Conclusions: The review identified reciprocal and reinforcing stereotypes affecting both GPs and service users. Possible mechanisms to counteract these barriers are discussed, including realistic expectations of medication, and the need for increased information sharing and trust between GPs and service users. [ABSTRACT FROM AUTHOR]

Background: The aim of the TAILOR trial is to investigate the effect of closely monitored tapering/discontinuation versus maintenance therapy with antipsychotic medication in patients with newly diagnosed schizophrenia or persistent delusional disorder and with minimum 3 months' remission of psychotic symptoms.Methods and Design: Two hundred and fifty patients will be included from the psychiatric early intervention program, OPUS, in two regions in Denmark. Inclusion criteria are: ICD-10 diagnoses schizophrenia (F20, except F20.6) or persistent delusional disorder (F22), minimum 3 months' remission of psychotic symptoms and in treatment with antipsychotic medication (except clozapine). The patients will be randomized to maintenance therapy or tapering/discontinuation with antipsychotic medication in a 1-year intervention. The tapering/discontinuation group will be using a smartphone application to monitor early warning signs of psychotic relapse. Patients will be assessed at baseline, 1-, 2- and 5-year follow-up regarding psychotic and negative symptoms, side-effects of antipsychotic medication, social functioning, cognitive functioning, perceived health status, patient satisfaction, substance and alcohol use, sexual functioning and quality of life. The primary outcome will be remission of psychotic symptoms and no antipsychotic medication after 1 year. Secondary outcome measures will include: co-occurrence of remission of psychotic symptoms and 0-1-mg haloperidol equivalents of antipsychotic medication after 1-year intervention; antipsychotic dose; antipsychotic side effects; negative symptoms; social functioning; cognitive functioning; and patient satisfaction. Exploratory outcomes will include remission, clinical recovery, substance and alcohol use, sexual functioning, quality of life, self-beliefs of coping and user experience of support from health workers. Safety measures will include death, admissions to psychiatric hospital, severe self-harm and psychotic relapses.Discussion: The TAILOR trial will contribute knowledge about the effect of tapering/discontinuation of antipsychotic medication in the early phases of schizophrenia and related disorders and the results may guide future clinical treatment regimens of antipsychotic treatment.Trial Registration: EU Clinical Trials Register - EudraCT number: 2016-000565-23 . Registered on 5 February 2016. [ABSTRACT FROM AUTHOR]

Background: Personalizing medical care is becoming increasingly popular, particularly mental health care. There is growing interest in formalizing medical decision making based on evolving patient symptoms in an evidence-based manner. To determine optimal sequencing of treatments, the sequences themselves must be studied; this may be accomplished by using a sequential multiple assignment randomized trial (SMART). It has been hypothesized that SMART studies may improve participant retention and generalizability.Methods: We examine the hypotheses that SMART studies are more generalizable and have better retention than traditional randomized clinical trials via a case study of a SMART study of antipsychotic medications. We considered the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study, comparing the trial participant characteristics and overall retention to those of comparable trials found via a review of all related trials conducted from 2000 onwards.Results: A MEDLINE search returned 6435 results for primary screening; ultimately, 48 distinct trials were retained for analysis. The study population in CATIE was similar to, although perhaps less symptomatic than, the study populations of traditional randomized clinical trials (RCTs), suggesting no large gains in generalizability despite the pragmatic nature of the trial. However, CATIE did see good month-by-month retention.Conclusions: SMARTs offer the possibility of studying treatment sequences in a way that a series of traditional RCTs cannot. SMARTs may offer improved retention; however, this case study did not find evidence to suggest greater generalizability using this trial design.Trial Registration: ClinicalTrials.gov NCT00014001 . Registered on 6 April 2001. [ABSTRACT FROM AUTHOR]

Background: People with dementia living in care homes often have complex mental health problems, disabilities and social needs. Providing more comprehensive training for staff working in care home environments is a high national priority. It is important that this training is evidence based and delivers improvement for people with dementia residing in these environments. Well-being and Health for People with Dementia (WHELD) combines the most effective elements of existing approaches to develop a comprehensive but practical staff training intervention. This optimised intervention is based on a factorial study and qualitative evaluation, to combine: training on person-centred care, promoting person-centred activities and interactions, and providing care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes. Design: The trial will be a randomised controlled two-arm cluster single blind trial that will take place for nine months across 80 care homes in the United Kingdom. Discussion: The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health than the usual care provided to people with dementia living in nursing homes. This study will be the largest and best powered randomised controlled trial (RCT) evaluating the benefits of an augmented person-centred care training intervention in care homes worldwide. [ABSTRACT FROM AUTHOR]

Background: People living in care homes often have complex mental and physical health problems, disabilities and social needs which are compounded by the use of psychiatric and other drugs. In the UK dementia care is a national priority with a vast impact on services. WHELD combines the most effective elements of existing approaches to develop a comprehensive but practical intervention. This will be achieved by training care staff to provide care that is focused on an understanding of the individual and their needs; and by using additional components such as exercise, activities and social interaction to improve mental health and quality of life (QoL) and reduce the use of sedative drugs. Design: Work Package 3 (WP3) is the pilot randomised trial and qualitative evaluation to help develop a future definitive randomised controlled clinical trial. The study design is a cluster randomised 2x2x2 factorial design with two replications in 16 care homes. Each care home is randomized to receive one of the eight possible permutations of the four key interventions, with each possible combination delivered in two of the 16 homes. Each cluster includes a minimum of 12 participants (depending upon size of the care home, the number of people with dementia and the number consenting). Discussion: The overarching goal of the programme is to provide an effective, simple and practical intervention which improves the mental health of, and reduces sedative drug use in, people with dementia in care homes and which can be implemented nationally in all UK care homes as an NHS intervention. [ABSTRACT FROM AUTHOR]

Background: Antipsychotic-induced weight gain constitutes a major unresolved clinical problem which may ultimately be associated with reducing life expectancy by 25 years. Overweight is associated with brain deterioration, cognitive decline and poor quality of life, factors which are already compromised in normal weight patients with schizophrenia. Here we outline the current strategies against antipsychotic-induced weight gain, and we describe peripheral and cerebral effects of the gut hormone glucagon-like peptide-1 (GLP-1). Moreover, we account for similarities in brain changes between schizophrenia and overweight patients. Discussion: Current interventions against antipsychotic-induced weight gain do not facilitate a substantial and lasting weight loss. GLP-1 analogs used in the treatment of type 2 diabetes are associated with significant and sustained weight loss in overweight patients. Potential effects of treating schizophrenia patients with antipsychotic-induced weight gain with GLP-1 analogs are discussed. Conclusions: We propose that adjunctive treatment with GLP-1 analogs may constitute a new avenue to treat and prevent metabolic and cerebral deficiencies in schizophrenia patients with antipsychotic-induced weight gain. Clinical research to support this idea is highly warranted. [ABSTRACT FROM AUTHOR]

Background: The aims of this study were to describe outcome with respect to persistent psychotic symptoms, relapse of positive symptoms, hospital admissions, and application of treatment by coercion among patients with recent onset schizophrenia being adherent and nonadherent to anti-psychotic medication. Materials and methods: The study included 50 patients with recent onset schizophrenia, schizoaffective or schizophreniform disorders. The patients were clinically stable at study entry and had less than 2 years duration of psychotic symptoms. Good adherence to antipsychotic medication was defined as less than one month without medication. Outcomes for poor and good adherence were compared over a 24-month follow-up period. Results: The Odds Ratio (OR) of having a psychotic relapse was 10.27 and the OR of being admitted to hospital was 4.00 among non-adherent patients. Use of depot-antipsychotics were associated with relapses (OR = 6.44). Conclusion: Non-adherence was associated with relapse, hospital admission and having persistent psychotic symptoms. Interventions to increase adherence are needed. Trial registration: Current Controlled Trials NCT00184509. [ABSTRACT FROM AUTHOR]