Erika Sims

Background/Objectives: Vaccinating care home staff is essential to protect vulnerable residents by reducing infection risks and creating a safer care environment. However, vaccine hesitancy amongst staff remains a challenge, particularly since the COVID-19 pandemic raised concerns about side effects and vaccination mandates. This study examines how the pandemic influenced flu vaccine hesitancy amongst UK care home staff. Methods: Data were collected from the FluCare trials conducted over the 2021–22 and 2022–23 winter seasons to explore the impact of concurrent mandatory and non-mandatory COVID-19 vaccination policies on flu vaccine uptake. A total of 52 interviews (21 from the feasibility study and 31 from the randomised control trial) were conducted with care home managers and staff. Thematic analysis identified key themes shaping staff attitudes toward flu vaccination. Results: Four central themes emerged regarding the impact of the pandemic on staff attitudes and the contextual influences shaping vaccine hesitance: (i) tension between autonomy and morals in vaccination decisions; (ii) the COVID ‘craze’ and the displacement of the flu vaccine; (iii) the role of the COVID ‘craze’ in staff vaccine fatigue; and (iv) conspiracies, (mis)information, and the significance of trust. Psychosocial theories on decision making and health behaviour were used to further interpret the findings. Conclusions: Our findings suggest that post-COVID-19 interventions in care home setting should address the issues of autonomy, vaccine fatigue, and trust to enhance vaccine uptake. Understanding these factors could support more effective strategies to address hesitancy amongst care home staff in future vaccination campaigns.

Background: People living in care homes often have problems with pain, anxiety and depression. Whether being on analgesia, anxiolytics or antidepressants has any bearing on pain severity and quality of life (QoL) in this population, requires further investigation.Objectives: (i) to examine the relationship between pain, anxiety and depression and medication use in care home residents and (ii) to compare those on medications to treat pain, anxiety and depression, and those who were not, and associations with pain severity and overall QoL.Methods: This was a secondary analysis of a randomised controlled trial testing a falls prevention intervention in care homes. We recorded pain, anxiety and depression, QoL measurements and prescribed medication use.Results: In 1589 participants, the mean age was 84.7 years (±9.3 SD), 32.2% were male and 67.3% had a diagnosis of dementia. 54.3% and 53.2% of participants had some level of pain and anxiety or depression respectively, regardless of prescribed medication use. There was a direct association between pain severity and being on any analgesia, opioid analgesia, and antidepressants, but no associations between pain severity and use of paracetamol and anxiolytics. QoL was best for residents with no pain and not on any analgesia, anxiolytics or antidepressants and worst for those with moderate-extreme pain and taking at least two of these classes of medications.Conclusion: Many care home residents live with pain, anxiety and depression. Addressing residents’ pain may also increase their quality of life, but using medication alone to reach this goal may be inadequate.

Background: To protect care home residents, annual staff influenza vaccination uptake is recommended to be greater than 75%. In the UK it is under 40%. With barriers and enablers to care home staff flu vaccine uptake identified, the purpose of this study was to feasibility test a theory informed intervention to improve vaccination rates. Methods: This was a five-arm (one intervention, four different control) study designed to inform the development of a definitive trial protocol. The intervention comprised of videos/posters to change vaccination attitudes, on-site clinics to increase access, a financial incentive for homes to reach target, and monthly monitoring of vaccination uptake. Control arms consisted of a mix of monthly or end of the study monitoring and provision of informational materials to identify the most suitable control arm for a definitive trial. Care homes were recruited via sector associations and purposively allocated. The feasibility outcomes were: ability to recruit enough homes; data quality (variables reported, variable completeness and consistency with a national reporting system); intervention implementation; control arm reactivity bias and signal of efficacy. Staff vaccination data was collated from homes and via a national healthcare tracking system. Process evaluation and economic data collation were undertaken to optimise intervention and research design. Results: Ten homes were recruited as per target within 11 weeks. Recruitment delays meant intervention delivery began towards end of flu season. Only 2 clinics took place in each home. All homes in intervention and chosen control arm (monthly monitoring only) reported all variables with over 90% completeness. There was a 15% difference between control homes’ reported vaccination rates and that in the national healthcare tracker, home reported data was more reliable. Signal of efficacy: intervention arm had a vaccination rate 13.6% higher than control arm. Bias: control arm did not have a higher vaccination rate than usual care control. Conclusions: Better recruitment processes, earlier start in flu season, and data collection direct from care homes are required for a definitive trial. A control arm of monthly monitoring only was identified as optimal for data collection purposes and minimising reactivity bias. The signal of efficacy was acceptable.

Background To protect care home residents, annual staff influenza vaccination uptake is recommended to be greater than 75%. In the UK it is under 40%. With barriers and enablers to care home staff flu vaccine uptake identified, the purpose of this study was to feasibility test a theory informed intervention to improve vaccination rates. Methods This was a five-arm (one intervention, four different control) study designed to inform the development of a definitive trial protocol. The intervention comprised of videos/posters to change vaccination attitudes, on-site clinics to increase access, a financial incentive for homes to reach target, and monthly monitoring of vaccination uptake. Control arms consisted of a mix of monthly or end of the study monitoring and provision of informational materials to identify the most suitable control arm for a definitive trial. Care homes were recruited via sector associations and purposively allocated. The feasibility outcomes were: ability to recruit enough homes; data quality (variables reported, variable completeness and consistency with a national reporting system); intervention implementation; control arm reactivity bias and signal of efficacy. Staff vaccination data was collated from homes and via a national healthcare tracking system. Process evaluation and economic data collation were undertaken to optimise intervention and research design. Results Ten homes were recruited as per target within 11 weeks. Recruitment delays meant intervention delivery began towards end of flu season. Only 2 clinics took place in each home. All homes in intervention and chosen control arm (monthly monitoring only) reported all variables with over 90% completeness. There was a 15% difference between control homes’ reported vaccination rates and that in the national healthcare tracker, home reported data was more reliable. Signal of efficacy: intervention arm had a vaccination rate 13.6% higher than control arm. Bias: control arm did not have a higher vaccination rate than usual care control. Conclusions Better recruitment processes, earlier start in flu season, and data collection direct from care homes are required for a definitive trial. A control arm of monthly monitoring only was identified as optimal for data collection purposes and minimising reactivity bias. The signal of efficacy was acceptable. Trial registration ISRCTN 14727552 Registered on 27/08/2021. Secondary identifiers: IRAS 305371

Background: Influenza (flu) vaccination rates in UK care home staff are extremely low. Less than 40% of staff in care homes are vaccinated for influenza (flu), presenting risks to the health of frail residents and potential staff absence from cross-infection. Staff often do not perceive a need for vaccination and are unaware they are entitled to free flu vaccination. The FluCare study, a cluster randomised control trial (RCT), uses behavioural interventions to address barriers. Videos, posters, and leaflets are intended to raise awareness of flu vaccination benefits and debunk myths. On-site staff vaccination clinics increase accessibility. Financial incentives to care homes for improved vaccination rates and regular monitoring influence the environment. This paper outlines the planned process evaluation which will describe the intervention’s mechanisms of action, explain any changes in outcomes, identify local adaptations, and inform design of the implementation phase. Methods/design: A mixed method process evaluation to inform the interpretation of trial findings. Objectives: • Describe the intervention as delivered in terms of dose and fidelity, including adaptations and variations across care homes. • Explore the effects of individual intervention components on primary outcomes. • Investigate the mechanisms of impact. • Describe the perceived effectiveness of relevant intervention components (including videos, leaflets, posters, and flu clinics) from participant perspectives (care home manager, care home staff, flu clinic providers). • Describe the characteristics of care homes and participants to assess reach. A purposive sample of twenty care homes (ten in the intervention arm, ten in the control arm) for inclusion in the process evaluation. Data will include (1) study records including care home site profiles, (2) responses to a mechanism of action questionnaire, and (3) semi-structured interviews with care home staff and clinic providers. Quantitative data will be descriptively reported. Interview data will be thematically analysed and then categories mapped to the Theoretical Domains Framework. Discussion: Adopting this systematic and comprehensive process evaluation approach will help ensure data is captured on all aspects of the trial, enabling a full understanding of the intervention implementation and RCT findings. Trial registration: ISRCTN ISRCTN22729870. Registered on 24 August 2022.

The care home staff influenza vaccination rate in England is significantly lower than the 75% World Health Organisation recommendation. This represents a substantial potential for resident harm. Barriers to staff vaccination stem from individual and organisational levels. Existing interventions address some but not all barriers and are not underpinned by behavioural science theory. This study aims to estimate the effectiveness and cost-effectiveness of a theory-informed intervention to improve care home staff vaccination rates compared to routine practice.Set in care homes with both nursing and residential focus, and a range of ownership status, only homes providing long stay care to older people with a staff vaccination rate below 40% are eligible to participate. Participation expressions of interest will be sought using a variety of approaches prior to seeking consent.The primary outcome measure is the proportion of staff vaccinated at 6 months, with secondary outcome measures being proportion vaccinated at 3 months, numbers of staff sick days, general practitioner and nurse visits to care home, care home resident hospitalisations and mortality.Based on the assumptions that the mean cluster (care home) size is 54 staff, a coefficient of variation of 0.48, control vaccination rate is 55%, intervention 75%, intra-cluster correlation coefficient of 0.2 and with 90% power, and 20% attrition, we require 39 care homes per arm.Blocked randomisation will be at the level of care home, stratified by the proportion of non-white care home staff, and implemented by Norwich Clinical Trials Unit.The intervention comprises co-designed information videos and posters, provision of in-house staff vaccination clinics, and incentive scheme and monthly data collection on trial outcomes. Beyond usual practice, the control arm will additionally contribute monthly data.Data will be collected at the start, monthly and at 6 months, and analysis will be blind to allocation. Statistical analysis will use the intention-to-treat principle with the difference in vaccination rates between groups compared using a random effect logistic regression model at the staff-level.This will be the first study to use a theory-informed intervention designed to comprehensively address identified barriers to care home staff influenza vaccination.Trial registration: ISRCTN ISRCTN22729870. Registered on 24 August 22. Secondary identifiers: R209939, IRAS 316820, CPMS 53812.

Primary care access can be challenging for older, rural, socio-economically disadvantaged populations. Here we report the I-ACT cluster feasibility trial which aims to assess the feasibility of trial design and context-sensitive intervention to improve primary care access for this group and so expand existing theory. Four general practices were recruited; three randomised to intervention and one to usual care. Intervention practices received £1500, a support manual and four meetings to develop local, innovative solutions to improve the booking system and transport. Patients aged over 64 years old and without household car access were recruited to complete questionnaires when booking an appointment or attending the surgery. Outcome measures at 6 months included: self-reported ease of booking an appointment and transport; health care use; patient activation; capability; and quality of life. A process evaluation involved observations and interviews with staff and participants. Thirty-four patients were recruited (26 female, eight male, mean age 81.6 years for the intervention group and 79.4 for usual care) of 1143 invited (3% response rate). Most were ineligible because of car access. Twenty-nine participants belonged to intervention practices and five to usual care. Practice-level data was available for all participants, but participant self-reported data was unavailable for three. Fifty-six appointment questionnaires were received based on 150 appointments (37.3%). Practices successfully designed and implemented the following context-sensitive interventions: Practice A: a stacked telephone system and promoting community transport; Practice B: signposting to community transport, appointment flexibility, mobility scooter charging point and promoting the role of receptionists; and Practice C: local taxi firm partnership and training receptionists. Practices found the process acceptable because it gave freedom, time and resource to be innovative or provided an opportunity to implement existing ideas. Data collection methods were acceptable to participants, but some found it difficult remembering to complete booking and appointment questionnaires. Expanded theory highlighted important mechanisms, such as reassurance, confidence, trust and flexibility. Recruiting older participants without access to a car proved challenging. Retention of participants and practices was good but only about a third of appointment questionnaires were returned. This study design may facilitate a shift from one-size-fits-all interventions to more context-sensitive interventions. ISRCTN18321951 , Registered on 6 March 2017.

Despite effective treatments and long-standing management guidelines, there are approximately 1400 hospital admissions for asthma weekly in the United Kingdom (UK), many of which could be avoided. In our previous research, a secondary analysis of the intervention (ARRISA) suggested an improvement in the management of at-risk asthma patients in primary care. ARRISA involved identifying individuals at risk of adverse asthma events, flagging their electronic health records, training practice staff to develop and implement practice-wide processes of care when alerted by the flag, plus motivational reminders. We now seek to determine the effectiveness and cost-effectiveness of ARRISA in reducing asthma-related crisis events. We are undertaking a pragmatic, two-arm, multicentre, cluster randomised controlled trial, plus health economic and process evaluation. We will randomise 270 primary care practices from throughout the UK covering over 10,000 registered patients with ‘at-risk asthma’ identified according to a validated algorithm. Staff in practices randomised to the intervention will complete two 45-min eLearning modules (an individually completed module giving background to ARRISA and a group-completed module to develop practice-wide pathways of care) plus a 30-min webinar with other practices. On completion of training at-risk patients’ records will be coded so that a flag appears whenever their record is accessed. Practices will receive a phone call at 4 weeks and a reminder video at 6 weeks and 6 months. Control practices will continue to provide usual care. We will extract anonymised routine patient data from primary care records (with linkage to secondary care data) to determine the percentage of at-risk patients with an asthma-related crisis event (accident and emergency attendances, hospitalisations and deaths) after 12 months (primary outcome). We will also capture the time to crisis event, all-cause hospitalisations, asthma control and any changes in practice asthma management for at-risk and all patients with asthma. Cost-effectiveness analysis and mixed-methods process evaluations will also be conducted. This study is novel in terms of using a practice-wide intervention to target and engage with patients at risk from their asthma and is innovative in the use of routinely captured data with record linkage to obtain trial outcomes. ISRCTN95472706 . Registered on 5 December 2014.

Incorrect inhaler technique is a common cause of poor asthma control. This two-phase pragmatic study evaluated inhaler technique mastery and maintenance of mastery with DuoResp® (budesonide-formoterol [BF]) Spiromax® compared with Symbicort® (BF) Turbuhaler® in patients with asthma who were receiving inhaled corticosteroids/long-acting β2-agonists. In the initial cross-sectional phase, patients were randomized to a 6-step training protocol with empty Spiromax and Turbuhaler devices. Patients initially demonstrating ≥1 error with their current device, and then achieving mastery with both Spiromax and Turbuhaler (absence of healthcare professional [HCP]-observed errors), were eligible for the longitudinal phase. In the longitudinal phase, patients were randomized to BF Spiromax or BF Turbuhaler. Co-primary endpoints were the proportions of patients achieving device mastery after three training steps and maintaining device mastery (defined as the absence of HCP-observed errors after 12 weeks of use). Secondary endpoints included device preference, handling error frequency, asthma control, and safety. Exploratory endpoints included assessment of device mastery by an independent external expert reviewing video recordings of a subset of patients. Four hundred ninety-three patients participated in the cross-sectional phase, and 395 patients in the longitudinal phase. In the cross-sectional phase, more patients achieved device mastery after three training steps with Spiromax (94%) versus Turbuhaler (87%) (odds ratio [OR] 3.77 [95% confidence interval (CI) 2.05–6.95], p < 0.001). Longitudinal phase data indicated that the odds of maintaining inhaler mastery at 12 weeks were not statistically significantly different (OR 1.26 [95% CI 0.80–1.98], p = 0.316). Asthma control improved in both groups with no significant difference between groups (OR 0.11 [95% CI -0.09–0.30]). An exploratory analysis indicated that the odds of maintaining independent expert-verified device mastery were significantly higher for patients using Spiromax versus Turbuhaler (OR 2.11 [95% CI 1.25–3.54]). In the cross-sectional phase, a significantly greater proportion of patients using Spiromax versus Turbuhaler achieved device mastery; in the longitudinal phase, the proportion of patients maintaining device mastery with Spiromax versus Turbuhaler was similar. An exploratory independent expert-verified analysis found Spiromax was associated with higher levels of device mastery after 12 weeks. Asthma control was improved by treatment with both BF Spiromax and BF Turbuhaler. EudraCT 2013-004630-14 (registration date 23 January 2014); NCT02570425 .

Health and social care provision for an ageing population is a global priority. Provision for those with dementia and hip fracture has specific and growing importance. Older people who break their hip are recognised as exceptionally vulnerable to experiencing confusion (including but not exclusively, dementia and/or delirium and/or cognitive impairment(s)) before, during or after acute admissions. Older people experiencing hip fracture and confusion risk serious complications, linked to delayed recovery and higher mortality post-operatively. Specific care pathways acknowledging the differences in patient presentation and care needs are proposed to improve clinical and process outcomes. This protocol describes a multi-centre, feasibility, cluster-randomised, controlled trial (CRCT) to be undertaken across ten National Health Service hospital trusts in the UK. The trial will explore the feasibility of undertaking a CRCT comparing the multicomponent PERFECTED enhanced recovery intervention (PERFECT-ER), which acknowledges the differences in care needs of confused older patients experiencing hip fracture, with standard care. The trial will also have an integrated process evaluation to explore how PERFECT-ER is implemented and interacts with the local context. The study will recruit 400 hip fracture patients identified as experiencing confusion and will also recruit “suitable informants” (individuals in regular contact with participants who will complete proxy measures). We will also recruit NHS professionals for the process evaluation. This mixed methods design will produce data to inform a definitive evaluation of the intervention via a large-scale pragmatic randomised controlled trial (RCT). The trial will provide a preliminary estimate of potential efficacy of PERFECT-ER versus standard care; assess service delivery variation, inform primary and secondary outcome selection, generate estimates of recruitment and retention rates, data collection difficulties, and completeness of outcome data and provide an indication of potential economic benefits. The process evaluation will enhance knowledge of implementation delivery and receipt. ISRCTN, 99336264 . Registered on 5 September 2016.