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Abstract Objective: The acceptability of an electronic HH monitoring system (EHHMS) was evaluated among hospital staff members. Design: An electronic HH monitoring system was implemented in June 2020 at a large, academic medical center. An interdisciplinary team developed a cross-sectional survey to gather staff perceptions of the EHHMS. Setting: The survey was conducted at a public, tertiary acute care hospital. Participants: The survey included current employees and staff. 1,273 participants responded. The mean age was 44.9 years (SD = 13.5). Most of the samples were female (71%) and non-Hispanic white (83%). Methods: A survey was conducted between June and July 2021. Responses were analyzed using Stata statistical software. Multiple logistic regression models were constructed to examine factors associated with negative perceptions of the EHHMS and its radiofrequency identification (RFID) badge. Supporting qualitative analyses were performed using Atlas.ti version 9. Results: Three-quarters (75%) of respondents reported neutral to negative perceptions of the EHHMS and its associated badge. Respondents reported limited influence on HH practices. Age, campus location, length of employment, job role, and opinion on data sharing were associated with negative perceptions of the EHHMS and RFID badge. Position in a direct patient care role was associated with negative perceptions of the RFID badge. Conclusions: Perceptions of the EHHMS aligned with previous research. Identified associations provide opportunities for targeted education, outreach, and intervention to increase acceptability and uptake. Lack of acceptance is explained by poorly perceived ease of use and usefulness, as well as challenges in implementation.

Abstract Background Mental health recovery narratives are first-person lived experience accounts of recovery from mental health problems, which refer to events or actions over a period of time, and which include elements of adversity or struggle, and also self-defined or observable strengths, successes, or survival. Recorded recovery narratives are those presented in invariant form, including text, audio, or video. In a previous publication, we presented a protocol for three pragmatic trials of the Narrative Experiences Online (NEON) Intervention, a web application recommending recorded recovery narratives to participants. The aim of the definitive NEON Trial was to understand whether the NEON Intervention benefitted people with experience of psychosis. The aim of the smaller NEON-O and NEON-C trials was to evaluate the feasibility of conducting definitive trials of the NEON Intervention with people (1) experiencing non-psychosis mental health problems and (2) who informally care for others experiencing mental health problems. An open recruitment strategy with a 60-week recruitment period was developed. Recruitment for the NEON Trial and NEON-O Trial targeted mental health service users and people not using mental health services. The NEON Trial recruited to time and target. The NEON-O Trial achieved its target in 10 weeks. Analysis considered by a Programme Steering Committee after the target was achieved demonstrated a definitive result could be obtained if the trial was adapted for recruitment to continue. The UK Health Research Authority approved all needed amendments following ethical review. Purpose of this article To describe the decision-making process for amending the NEON-O Trial and to describe amendments made to the NEON-O Trial to enable a definitive result. The article describes amendments to the aims, objectives, design, power calculation, recruitment rate, process evaluation design, and informed consent documents. The extended NEON-O Trial adopts analysis principles previously specified for the NEON Trial. The article provides a model for other studies adapting feasibility trials into definitive trials. Trial registration All trials prospectively registered. NEON Trial: ISRCTN11152837 . Registered on 13th August 2018. NEON-C Trial: ISRCTN76355273 . Registered on 9th January 2020. NEON-O Trial: ISRCTN63197153 . Registered on 9th January 2020. The NEON-O Trial ISRCTN was updated when amendments were approved. Amendment details: NOSA2, 30th October 2020.

Background: Electronic hand hygiene monitoring systems (EHHMSs) are being increasingly utilized to improve hand hygiene outcomes. Following the implementation of an EHHMS at a large, academic medical center, an interdisciplinary team developed a web-based survey to gather information on employee’s perceptions and behaviors surrounding the EHHMS. Methods: In total, 1,273 complete responses were collected. Responses were analyzed using Stata version 16 statistical software with 2-tailed tests and .05 significance level. Multivariate logistic regression models were constructed to examine factors associated with negative perceptions of the EHHMS and of wearing the EHHMS radiofrequency identification (RFID) badge. Supporting qualitative analysis was performed using Atlas.ti version 9 software. Results: The general sentiment toward the monitoring system was neutral (38%) to negative (37%). The same was true for respondents’ sentiments toward wearing the RFID badge. Of respondents who interact with the system, 48% feel that the system does not capture hand hygiene data accurately. The EHHMS had limited influence on employee’s hand hygiene habits: 27% significant influence and 54% little-to-no influence. Respondents of younger age, those employed as a registered nurse, scientist, physician, or master’s level clinician, and those working at the satellite hospital were significantly more likely to have negative perceptions of the EHHMS. Negative perceptions were also significantly more likely among respondents familiar with the institution’s hand hygiene policy and those who had a negative opinion of seeing the hand hygiene data of others. Negative perceptions of the EHHMS RFID badge were significantly more likely among respondents of younger age, those employed as a registered nurse, scientist, physician, or master’s level clinician, those working at the satellite hospital, and those with a negative perception of seeing the hand hygiene data of others. Employment in a role providing direct patient care and those employed at the institution for >1 year were also significantly more likely to have a negative perception. Conclusions: Negative and neutral opinions dominate perceptions of the EHHMS considered in this analysis. Respondents expressed concerns with accuracy of the EHHMS data collection. The system’s limited influence is likely a result of limited familiarity, limited performance feedback, and employee frustration and concerns. These findings provide opportunities for improvement in future implementation of EHHMS. Based on these results, implementation of EHHMS would be best be supported by coordinated backing from administration and leadership, advanced planning and education, and frequent, effective communication. Additional research and evaluation are required to optimize implementation of electronic hand hygiene monitoring systems, with the goal of improving hand hygiene outcomes.

Abstract Background Mental health recovery narratives have been defined as first-person lived experience accounts of recovery from mental health problems which refer to events or actions over a period of time and which include elements of adversity or struggle, and also self-defined strengths, successes or survival. They are readily available in invariant recorded form, including text, audio or video. Previous studies have provided evidence that receiving recorded recovery narratives can provide benefits to recipients. This protocol describes three pragmatic trials that will be conducted by the Narrative Experiences Online (NEON) study using the NEON Intervention, a web application that delivers recorded recovery narratives to its users. The aim of the NEON Trial is to understand whether receiving online recorded recovery narratives through the NEON Intervention benefits people with experience of psychosis. The aim of the NEON-O and NEON-C trials is to evaluate the feasibility of conducting a definitive trial on the use of the NEON Intervention with people experiencing non-psychosis mental health problems and those who care for others experiencing mental health problems respectively. Methods The NEON Trial will recruit 683 participants with experience of psychosis. The NEON-O Trial will recruit at least 100 participants with experience of non-psychosis mental health problems. The NEON-C Trial will recruit at least 100 participants with experience of caring for others who have experienced mental health problems. In all three trials, participants will be randomly allocated into one of two arms. Intervention arm participants will receive treatment as usual plus immediate access to the NEON Intervention for 1 year. Control arm participants will receive treatment as usual plus access to the NEON Intervention after 1 year. All participants will complete demographics and outcome measures at baseline, 1 week, 12 weeks and 52 weeks. For the NEON Trial, the primary outcome measure is the Manchester Short Assessment of Quality of Life at 52 weeks, and secondary outcome measures are the CORE-10, Herth Hope Index, Mental Health Confidence Scale and Meaning in Life Questionnaire. A cost-effectiveness analysis will be conducted using data collected through the EQ-5D-5 L and the Client Service Receipt Inventory. Discussion NEON Trial analyses will establish both effectiveness and cost-effectiveness of the NEON Intervention for people with experience of psychosis, and hence inform future clinical recommendations for this population. Trial registration All trials were prospectively registered with ISRCTN. NEON Trial: ISRCTN11152837 . Registered on 13 August 2018. NEON-C Trial: ISRCTN76355273 . Registered on 9 January 2020. NEON-O Trial: ISRCTN63197153 . Registered on 9 January 2020.

Abstract Background Suicide is a leading cause of death globally. Suicide deaths are elevated in those experiencing severe mental health problems, including schizophrenia. Psychological talking therapies are a potentially effective means of alleviating suicidal thoughts, plans, and attempts. However, talking therapies need to i) focus on suicidal experiences directly and explicitly, and ii) be based on testable psychological mechanisms. The Cognitive AppRoaches to coMbatting Suicidality (CARMS) project is a Randomised Controlled Trial (RCT) which aims to investigate both the efficacy and the underlying mechanisms of a psychological talking therapy for people who have been recently suicidal and have non-affective psychosis. Methods The CARMS trial is a two-armed single-blind RCT comparing a psychological talking therapy (Cognitive Behavioural Suicide Prevention for psychosis [CBSPp]) plus Treatment As Usual (TAU) with TAU alone. There are primary and secondary suicidality outcome variables, plus mechanistic, clinical, and health economic outcomes measured over time. The primary outcome is a measure of suicidal ideation at 6 months after baseline. The target sample size is 250, with approximately 125 randomised to each arm of the trial, and an assumption of up to 25% attrition. Hence, the overall recruitment target is up to 333. An intention to treat analysis will be used with primary stratification based on National Health Service (NHS) recruitment site and antidepressant prescription medication. Recruitment will be from NHS mental health services in the North West of England, UK. Participants must be 18 or over; be under the care of mental health services; have mental health problems which meet ICD-10 non-affective psychosis criteria; and have experienced self-reported suicidal thoughts, plans, and/or attempts in the 3 months prior to recruitment. Nested qualitative work will investigate the pathways to suicidality, experiences of the therapy, and identify potential implementation challenges beyond a trial setting as perceived by numerous stake-holders. Discussion This trial has important implications for countering suicidal experiences for people with psychosis. It will provide definitive evidence about the efficacy of the CBSPp therapy; the psychological mechanisms which lead to suicidal experiences; and provide an understanding of what is required to implement the intervention into services should it be efficacious. Trial registration ClinicalTrials.gov ( NCT03114917 ), 14th April 2017. ISRCTN (reference ISRCTN17776666 https://doi.org/10.1186/ISRCTN17776666 ); 5th June 2017). Registration was recorded prior to participant recruitment commencing.

Background: People with cystic fibrosis frequently have low levels of adherence to inhaled medications. Objectives: The objectives were to develop and evaluate an intervention for adults with cystic fibrosis to improve adherence to their inhaled medication. Design: We used agile software methods to develop an online platform. We used mixed methods to develop a behaviour change intervention for delivery by an interventionist. These were integrated to become the CFHealthHub intervention. We undertook a feasibility study consisting of a pilot randomised controlled trial and process evaluation in two cystic fibrosis centres. We evaluated the intervention using an open-label, parallel-group randomised controlled trial with usual care as the control. Participants were randomised in a 1 : 1 ratio to intervention or usual care. Usual care consisted of clinic visits every 3 months. We undertook a process evaluation alongside the randomised controlled trial, including a fidelity study, a qualitative interview study and a mediation analysis. We undertook a health economic analysis using both a within-trial and model-based analysis. Setting: The randomised controlled trial took place in 19 UK cystic fibrosis centres. Participants: Participants were people aged ≥ 16 years with cystic fibrosis, on the cystic fibrosis registry, not post lung transplant or on the active transplant list, who were able to consent and not using dry-powder inhalers. Intervention: People with cystic fibrosis used a nebuliser with electronic monitoring capabilities. This transferred data automatically to a digital platform. People with cystic fibrosis and clinicians could monitor adherence using these data, including through a mobile application (app). CFHealthHub displayed graphs of adherence data as well as educational and problem-solving information. A trained interventionist helped people with cystic fibrosis to address their adherence. Main outcome measures: Randomised controlled trial – adjusted incidence rate ratio of pulmonary exacerbations meeting the modified Fuchs criteria over a 12-month follow-up period (primary outcome); change in percentage adherence; and per cent predicted forced expiratory volume in 1 second (key secondary outcomes). Process evaluation – percentage fidelity to intervention delivery, and participant and interventionist perceptions of the intervention. Economic modelling – incremental cost per quality-adjusted life-year gained. Results: Randomised controlled trial – 608 participants were randomised to the intervention (n = 305) or usual care (n = 303). To our knowledge, this was the largest randomised controlled trial in cystic fibrosis undertaken in the UK. The adjusted rate of exacerbations per year (primary outcome) was 1.63 in the intervention and 1.77 in the usual-care arm (incidence rate ratio 0.96, 95% confidence interval 0.83 to 1.12; p = 0.638) after adjustment for covariates. The adjusted difference in mean weekly normative adherence was 9.5% (95% confidence interval 8.6% to 10.4%) across 1 year, favouring the intervention. Adjusted mean difference in forced expiratory volume in 1 second (per cent) predicted at 12 months was 1.4% (95% confidence interval –0.2% to 3.0%). No adverse events were related to the intervention. Process evaluation – fidelity of intervention delivery was high, the intervention was acceptable to people with cystic fibrosis, participants engaged with the intervention [287/305 (94%) attended the first intervention visit], expected mechanisms of action were identified and contextual factors varied between randomised controlled trial sites. Qualitative interviews with 22 people with cystic fibrosis and 26 interventionists identified that people with cystic fibrosis welcomed the objective adherence data as proof of actions to self and others, and valued the relationship that they built with the interventionists. Economic modelling – the within-trial analysis suggests that the intervention generated 0.01 additional quality-adjusted life-years at an additional cost of £865.91 per patient, leading to an incremental cost-effectiveness ratio of £71,136 per quality-adjusted life-year gained. This should be interpreted with caution owing to the short time horizon. The health economic model suggests that the intervention is expected to generate 0.17 additional quality-adjusted life-years and cost savings of £1790 over a lifetime (70-year) horizon; hence, the intervention is expected to dominate usual care. Assuming a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, the probability that the intervention generates more net benefit than usual care is 0.89. The model results are dependent on assumptions regarding the duration over which costs and effects of the intervention apply, the impact of the intervention on forced expiratory volume in 1 second (per cent) predicted and the relationship between increased adherence and drug-prescribing levels. Limitations: Number of exacerbations is a sensitive and valid measure of clinical change used in many trials. However, data collection of this outcome in this context was challenging and could have been subject to bias. It was not possible to measure baseline adherence accurately. It was not possible to quantify the impact of the intervention on the number of packs of medicines prescribed. Conclusions: We developed a feasible and acceptable intervention that was delivered to fidelity in the randomised controlled trial. We observed no statistically significant difference in the primary outcome of exacerbation rates over 12 months. We observed an increase in normative adherence levels in a disease where adherence levels are low. The magnitude of the increase in adherence may not have been large enough to affect exacerbations. Future work: Given the non-significant difference in the primary outcome, further research is required to explore why an increase in objective normative adherence did not reduce exacerbations and to develop interventions that reduce exacerbations. Trial registration: Work package 3.1: Current Controlled Trials ISRCTN13076797. Work packages 3.2 and 3.3: Current Controlled Trials ISRCTN55504164. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 11. See the NIHR Journals Library website for further project information.

Background: This programme of research addressed shortcomings in the care of three groups of older patients: patients discharged from acute medical units (AMUs), patients with dementia and delirium admitted to general hospitals, and care home residents. Methods: In the AMU workstream we undertook literature reviews, performed a cohort study of older people discharged from AMU (Acute Medical Unit Outcome Study; AMOS), developed an intervention (interface geriatricians) and evaluated the intervention in a randomised controlled trial (Acute Medical Unit Comprehensive Geriatric Assessment Intervention Study; AMIGOS). In the second workstream we undertook a cohort study of older people with mental health problems in a general hospital, developed a specialist unit to care for them and tested the unit in a randomised controlled trial (Trial of an Elderly Acute care Medical and mental health unit; TEAM). In the third workstream we undertook a literature review, a cohort study of a representative sample of care home residents and a qualitative study of the delivery of health care to care home residents. Results: Although 222 of the 433 (51%) patients recruited to the AMIGOS study were vulnerable enough to be readmitted within 3 months, the trial showed no clinical benefit of interface geriatricians over usual care and they were not cost-effective. The TEAM study recruited 600 patients and there were no significant benefits of the specialist unit over usual care in terms of mortality, institutionalisation, mental or functional outcomes, or length of hospital stay, but there were significant benefits in terms of patient experience and carer satisfaction with care. The medical and mental health unit was cost-effective. The care home workstream found that the organisation of health care for residents in the UK was variable, leaving many residents, whose health needs are complex and unpredictable, at risk of poor health care. The variability of health care was explained by the variability in the types and sizes of homes, the training of care home staff, the relationships between care home staff and the primary care doctors and the organisation of care and training among primary care doctors. Discussion: The interface geriatrician intervention was not sufficient to alter clinical outcomes and this might be because it was not multidisciplinary and well integrated across the secondary care–primary care interface. The development and evaluation of multidisciplinary and better-integrated models of care is justified. The specialist unit improved the quality of experience of patients with delirium and dementia in general hospitals. Despite the need for investment to develop such a unit, the unit was cost-effective. Such units provide a model of care for patients with dementia and delirium in general hospitals that requires replication. The health status of, and delivery of health care to, care home residents is now well understood. Models of care that follow the principles of comprehensive geriatric assessment would seem to be required, but in the UK these must be sufficient to take account of the current provision of primary health care and must recognise the importance of the care home staff in the identification of health-care needs and the delivery of much of that care. Trial registration: Current Controlled Trials ISRCTN21800480 (AMIGOS); ClinicalTrials.gov NCT01136148 (TEAM). Funding: This project was funded by the NIHR Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 3, No. 4. See the NIHR Journals Library website for further project information.