A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): study findings

BackgroundOne-fifth of conveyances to the emergency department (ED) are due to acute-on-chronic breathlessness. Paramedic breathlessness management may ease distress quicker and/or reduce ED conveyances. We evaluated the feasibility of a full trial of a paramedic delivered intervention to reduce avoidable conveyances (recruitment, randomisation, consent, training and intervention acceptability, adherence, data quality, best primary outcome, sample size estimation). The intervention comprised evidence-based non-drug techniques and a self-management booklet.MethodsThis mixed-methods feasibility cluster randomised controlled trial (ISRCTN80330546) with embedded qualitative study about trial processes, training and intervention delivery, randomised paramedics to usual care or to intervention+usual care. Retrospective patient consent to use call-out data and prospective patient/carer consent for follow-up was sought. Potential primary outcomes were breathlessness intensity (numerical rating scale) and ED conveyance. Follow-up included an interview for patients/carers and questionnaires at 14 days, 1 and 6 months and paramedic focus groups and survey.ResultsRecruitment was during the COVID-19 pandemic, leading to high demands on paramedics and fewer call-outs by eligible patients. We enrolled 29 paramedics;9 withdrew. Randomisation/trial procedures were acceptable. Paramedics recruited 13 patients;8 were followed up. Data quality was good. The intervention did not extend call-out time, was delivered with fidelity and no contamination and was acceptable to patients, carers, and paramedics. There were no repeat call-outs < 48 hours. Recruitment stop-go criteria were not met. We had insufficient data for sample size estimation.ConclusionsA full trial in the same circumstances is not feasible. However, valuable information was gained on recruitment, attrition, consent, training and intervention acceptability and adherence, and patient-reported data collection.

Implementing Affordable Socially Assistive Pet Robots in Care Homes Before and During the COVID-19 Pandemic: Stratified Cluster Randomized Controlled Trial and Mixed Methods Study.

BACKGROUND: Robot pets may assist in the challenges of supporting an aging population with growing dementia prevalence. Prior work has focused on the impacts of the robot seal Paro on older adult well-being, but recent studies have suggested the good acceptability and implementation feasibility of more affordable devices (Joy for All [JfA] cats and dogs). OBJECTIVE: We aimed to address the limited effectiveness research on JfA devices. METHODS: We conducted an 8-month, stratified, cluster randomized controlled trial in 8 care homes in Cornwall, United Kingdom. Over 4 months, 4 care homes each received 2 JfA devices (1 cat and 1 dog; intervention group), and 4 homes received care as usual (control group). Psychometrics were collected before and after the intervention to compare the change from baseline to follow-up between the groups. In the final 4 months, all 8 care homes received devices, but only qualitative data were collected owing to COVID-19 and reduced capacity. The primary outcome was neuropsychiatric symptoms (Neuropsychiatric Inventory [NPI] Nursing Home version). Care provider burden was a secondary outcome (occupational disruptiveness NPI subscale), alongside the Challenging Behavior scale, the Holden communication scale, the Campaign to End Loneliness questionnaire, and medication use. Qualitative data were collected through care staff observation calendars and end-of-study interviews to understand use, experience, and impact. We also collected demographic data and assessed dementia severity. In total, 253 residents had robot interaction opportunities, and 83 were consented for direct data collection. RESULTS: There was a significant difference in the total change from baseline to follow-up between the intervention and control groups for NPI (P<.001) and occupational disruptiveness (P=.03). Neuropsychiatric symptoms increased in the control group and decreased in the intervention group. No significant difference was seen for communication issues or challenging behavior. For NPI subdomains, there were significant differences from baseline to follow-up in delusions (P=.03), depression (P=.01), anxiety (P=.001), elation (P=.02), and apathy (P=.009), all of which decreased in the intervention group and increased slightly in the control group. The summative impact results suggested that most residents (46/54, 85%) who interacted with robots experienced a positive impact. Those who interacted had significantly higher dementia severity scores (P=.001). The qualitative results suggested good adoption, acceptability, and suitability for subjectively lonely individuals and lack of a novelty effect through sustained use, and demonstrated that the reasons for use were entertainment, anxiety, and agitation. CONCLUSIONS: Affordable robot pets hold potential for improving the well-being of care home residents and people with dementia, including reducing neuropsychiatric symptoms and occupational disruptiveness. This work suggests no novelty effect and contributes toward understanding robot pet suitability. Moreover, interactions were more common among residents with more moderate/severe dementia and those subjectively lonely. TRIAL REGISTRATION: ClinicalTrials.gov NCT04168463; https://www.clinicaltrials.gov/ct2/show/NCT04168463.

Mental Imagery to Reduce Alcohol-related harm in patients with alcohol dependence and alcohol-related liver damaGE: the MIRAGE pilot trial protocol.

INTRODUCTION: In the UK, alcohol use is the main driver of chronic liver disease and each year results in over 1 million unplanned hospital admissions and over 25 000 deaths from alcohol-related liver disease (ArLD). The only effective treatment to prevent progression of liver damage is reducing or ceasing alcohol consumption. Psychological and pharmacological therapies for alcohol misuse are ineffective in patients with ArLD. Functional imagery training (FIT) is a novel psychological therapy that builds on motivational interviewing techniques with multisensory imagery. This pilot trial aims to test the feasibility of training alcohol liaison nurses to deliver FIT therapy and of recruiting and retaining patients with ArLD and alcohol dependence to a randomised trial of FIT and treatment as usual (TAU) versus TAU alone. METHODS AND ANALYSIS: This is a randomised pilot trial of FIT and TAU versus TAU alone in 90 patients with ArLD and alcohol dependence admitted to one of four UK centres. The primary objectives are to estimate rates of screening, recruitment, randomisation, retention, adherence to FIT/TAU and a preliminary assessment of the FIT intervention in the ArLD population. Data from the pilot study will be used to finalise the design of a definitive randomised controlled trial to assess the effectiveness and cost-effectiveness of FIT. The proposed primary outcome measure for the definitive trial is self-reported alcohol use assessed using timeline follow-back. ETHICS AND DISSEMINATION: Research ethics approval was given by the Yorkshire and Humber-Bradford Leeds Research Ethics Committee (reference: 21/YH/0044). Eligible patients will be approached and written informed consent obtained prior to participation. Results will be disseminated through peer-reviewed open access journals, international conferences and a lay summary published on the Trials Unit website and made available to patient groups. TRIAL REGISTRATION NUMBER: ISRCTN41353774.

Mental Health Provision in UK Secondary Schools.

Research reports high levels of mental health problems faced by young people in the UK. Schools provide a range of mental health support services, although these are often not robustly evaluated. This paper aims to explore the mental health provision of secondary schools across two large regions in the North of England and provide comparisons to the mental health questionnaire scores of their pupils. Results are part of a wider study providing an overview of the mental health of secondary school pupils. Measures include the Strengths and Difficulties Questionnaire, distributed to year 8, 9, and 11 pupils attending secondary schools and a bespoke mental health service provision questionnaire for school staff at the same schools. A total of 6328 pupil questionnaires and 36 staff questionnaires were returned from 21 schools. Results showed a non-significant correlation between provision and young people's mental health scores and highlight a range of factors to take into consideration. There is a need to improve the evaluation and recording of school-based mental health provision. Mental health difficulties in young people are prevalent in schools. Future research is needed to elucidate which types of services are most helpful in preventing, supporting, and signposting those with mental health problems.

Health risk behaviours among people with severe mental ill health during the COVID-19 pandemic: Analysis of linked cohort data.

BACKGROUND: People with severe mental ill health (SMI) experience a mortality gap of 15-20 years. COVID-19 has amplified population health inequalities, and there is concern that people with SMI will be disproportionately affected. Understanding how health risk behaviours have changed during the pandemic is important when developing strategies to mitigate future increases in health inequalities. METHODS: We sampled from an existing cohort of people with SMI. Researchers contacted participants by phone or post to invite them to take part in a survey about how the pandemic had affected them. We asked people about their health risk behaviours and how these had changed during the pandemic. We created an index of changed behaviours, comprising dietary factors, smoking, lack of exercise, and drinking patterns. By creating data linkages, we compared their responses during pandemic restrictions to responses they gave prior to the pandemic. OUTCOMES: 367 people provided health risk data. The mean age of the participants was 50.5 (range = 20 to 86, SD ± 15.69) with 51.0% male and 77.4% white British. 47.5% of participants reported taking less physical activity during the pandemic and of those who smoke 54.5% reported smoking more heavily. Self-reported deterioration in physical health was significantly associated with an increase in health risk behaviours (adjusted OR for physical health 1.59, 95%CI 1.22-2.07; adjusted OR for Age 0.99, 95%CI 0.98-1.00). INTERPRETATION: COVID-19 is likely to amplify health inequalities for people with SMI. Health services should target health risk behaviours for people with SMI to mitigate the immediate and long lasting impacts of the COVID-19 pandemic.

Investigating smoking and nicotine dependence among people with severe mental illness during the COVID-19 pandemic: analysis of linked data from a UK Closing the Gap cohort.

Smoking rates are higher for people who use mental health services, which contributes substantially to health inequalities. Smoking can lead to worse COVID-19 outcomes, yet it remains unclear whether smoking has changed for people who use mental health services. We examined smoking patterns in a large clinical cohort of people with severe mental illness, before and during the pandemic. We found high levels of nicotine dependence and heavier patterns of smoking. Although some people had reported quitting, it is likely that smoking inequalities have become further entrenched. Mental health services should seek to mitigate this modifiable risk and source of poor health.

Assessment of cytokines, microRNA and patient related outcome measures in conversion disorder/functional neurological disorder (CD/FND): The CANDO clinical feasibility study.

BACKGROUND: Conversion disorder/functional neurological disorder (CD/FND) occurs often in neurological settings and can lead to long-term distress, disability and demand on health care services. Systemic low-grade inflammation might play a role, however, the pathogenic mechanism is still unknown. AIM: 1) To explore the feasibility to establish and assess a cohort of CD/FND with motor symptoms, involving persons with lived experience (PPI). 2) To generate proof of concept regarding a possible role for cytokines, microRNA, cortisol levels and neurocognitive symptoms in patients with motor CD/FND. METHOD: Feasibility study. RESULTS: The study showed active involvement of patients despite high clinical illness burden and disability, neurocognitive symptoms, childhood adverse experiences (ACE) and current life events. The study provided valuable knowledge regarding the feasibility of conducting a study in these patients that will inform future study phases. In the sample there were elevated levels of IL6, IL12, IL17A, IFNg, TNFa and VEGF-a, suggesting systemic low-grade inflammation. Also, microRNAs involved in inflammation and vascular inflammation were correlated with TNFa and VEGFa respectively, suggesting proof of concept for an epigenetic mechanism. Owing to the COVID-19 outbreak, the patient sample was limited to 15 patients. CONCLUSION: It is a novelty that this study is conducted in the clinical setting. This innovative, translational study explores stress-related SLI in CD/FND patients and the feasibility of a larger project aiming to develop new treatments for this vulnerable population. Given the positive findings, there is scope to conduct further research into the mechanism of disease in CD/FND.

Review of hygiene adaptations among UK doctors in controlling the spread of SARS-CoV-2 infection.

BACKGROUND: A significant number of healthcare workers around the world have contracted COVID-19 from their workplace, thus there is a need to investigate common hygiene practices. AIM: We aimed to describe the common hygiene adaptations of doctors in the hospital and at home. METHODS: A survey of 110 doctors in UK was carried out to determine their hygiene adaptations and practices. Data were collected on demographics and personal protective equipment compliance. RESULTS: The key findings were frequent hand washing (51%), change of clothing entering and leaving hospital (88% and 92%, respectively), taking a shower upon returning home (85%) and washing work attire at temperatures of 60-80°C (50%). A higher proportion of junior doctors washed their scrubs (p=0.004) and stethoscopes (p=0.014) compared with consultants and seniors. Female doctors cleaned their mobile phones (p=0.022) and work belongings (p=0.01) more frequently. CONCLUSION: This study signified that junior doctors were more meticulous in hygiene adaptations and female doctors were more fastidious in personal hygiene. The observations of this study may be beneficial in preventing transmission of infection to families of healthcare professionals and are important to implement in the case of a second wave of COVID-19.

Workplace Stress, Presenteeism, Absenteeism, and Resilience Amongst University Staff and Students in the COVID-19 Lockdown.

Background: This study explored how the COVID-19 outbreak and arrangements such as remote working and furlough affect work or study stress levels and functioning in staff and students at the University of York, UK. Methods: An invitation to participate in an online survey was sent to all University of York staff and students in May-June 2020. We measured stress levels [VAS-scale, Perceived Stress Questionnaire (PSQ)], mental health [anxiety (GAD-7), depression (PHQ-9)], physical health (PHQ-15, chronic medical conditions checklist), presenteeism, and absenteeism levels (iPCQ). We explored demographic and other characteristics as factors which may contribute to resilience and vulnerability for the impact of COVID-19 on stress. Results: One thousand and fifty five staff and nine hundred and twenty five students completed the survey. Ninety-eight per cent of staff and seventy-eight per cent of students worked or studied remotely. 7% of staff and 10% of students reported sickness absence. 26% of staff and 40% of the students experienced presenteeism. 22-24% of staff reported clinical-level anxiety and depression scores, and 37.2 and 46.5% of students. Staff experienced high stress levels due to COVID-19 (66.2%, labeled vulnerable) and 33.8% experienced low stress levels (labeled resilient). Students were 71.7% resilient vs. 28.3% non-resilient. Predictors of vulnerability in staff were having children [OR = 2.23; CI (95) = 1.63-3.04] and social isolation [OR = 1.97; CI (95) = 1.39-2.79] and in students, being female [OR = 1.62; CI (95) = 1.14-2.28], having children [OR = 2.04; CI (95) = 1.11-3.72], and social isolation [OR = 1.78; CI (95) = 1.25-2.52]. Resilience was predicted by exercise in staff [OR = 0.83; CI (95) = 0.73-0.94] and in students [OR = 0.85; CI (95) = 0.75-0.97]. Discussion: University staff and students reported high psychological distress, presenteeism and absenteeism. However, 33.8% of staff and 71.7% of the students were resilient. Amongst others, female gender, having children, and having to self-isolate contributed to vulnerability. Exercise contributed to resilience. Conclusion: Resilience occurred much more often in students than in staff, although psychological distress was much higher in students. This suggests that predictors of resilience may differ from psychological distress per se. Hence, interventions to improve resilience should not only address psychological distress but may also address other factors.