The role of community pharmacy in diabetes prevention

Background Diabetes Prevention Programmes (DPPs), comprising intensive lifestyle interventions, may delay or even prevent the onset of type 2 diabetes in Non-diabetic hyperglycaemia (NDH). Unfortunately, engagement with DPPs is variable with accessibility being a reported barrier; this may be addressed by community pharmacy involvement given its accessibility. The aim of this thesis was to explore the potential role of community pharmacy in diabetes prevention in England. Methods This thesis includes four studies; the first, a mixed methods study exploring engagement with the national DPP and eliciting views from people with NDH on the role of community pharmacy in diabetes prevention. The second, a qualitative study exploring views of healthcare providers and commissioners on the potential role of community pharmacy in diabetes prevention. The third, a questionnaire-based validation study. The fourth, a nominal group technique study designed to identify interventions most likely to facilitate successful implementation of community pharmacy-based diabetes prevention services (DPS). The studies were underpinned by the Behaviour Change Wheel framework which framed data collection, analysis and intervention development. Results The mixed methods study highlighted barriers to engagement in the national DPP including inconvenient location and session times and identified community pharmacy as a potential setting for delivering alternative DPS. The qualitative study and the subsequent validation questionnaire identified facilitators for the provision of community pharmacy-based DPS including the provision of integrated services in primary care. The final study identified key interventions for ensuring engagement with (e.g. service promotion) and delivery of (e.g. training) community pharmacy-based DPS. Conclusions The thesis provides an overview of evidence underpinning the role of community pharmacy in the provision of accessible DPS and presents a model for implementation. The proposed model, which advocates integration of primary care services, aligns with the community pharmacy contractual framework and the National Health Service Long Term Plan

A systematic review exploring characteristics of lifestyle modification interventions in newly diagnosed type 2 diabetes for delivery in community pharmacy

Objectives: The aim of this systematic review was to examine the characteristics of effective lifestyle modification interventions designed for patients with newly diagnosed type 2 diabetes mellitus (T2DM) in order to determine elements that have the potential to be delivered in the community pharmacy setting. Key findings: Seven studies, comprising three each of the interventions diet and structured education and one of supported exercise, were identified. Interventions were conducted in hospital diabetes clinics and clinics situated in both urban and rural areas. Interventions were delivered face to face by highly skilled personnel including physicians, nurses and dietitians. Duration of interventions ranged from 3 months to 5 years. Summary: Structured education and dietary interventions in newly diagnosed type 2 diabetes effectively controlled blood glucose levels without pharmacological intervention. Important characteristics included face to face, individualised and multicomponent interventions with a duration of at least 6 months. These characteristics demonstrate potential for delivery in a community pharmacy setting, given its current involvement in delivering face to face, individual services with diet and lifestyle components. Further research is required to provide evidence for ideal intervention duration and frequency as well as training requirements for pharmacists

The community pharmacy setting for diabetes prevention: views and perceptions of stakeholders

Background: Diabetes prevention programmes delay or prevent the onset of type 2 diabetes in people with pre-diabetes. To increase accessibility, national guidelines recommend delivering diabetes prevention programmes in primary care settings, including community pharmacy. This study aimed to explore the English community pharmacy setting as an option for delivering diabetes prevention services. Methods: Two focus groups and nine semi-structured interviews were conducted with stakeholders including, community pharmacists, general practitioners and commissioners. The topic guide was framed using the COM-B theoretical model for behaviour change to elicit practitioners’ capability, opportunity and motivation to engage with providing or referring to community pharmacy diabetes prevention services. Data were analysed thematically, and barriers/facilitators mapped to the COM-B framework. Results: Five themes were identified: ‘Pre-diabetes management and associated challenges’, ‘The community pharmacy setting’, ‘Awareness of community pharmacy services’, ‘Relationships and communication’ and ‘Delivery of community pharmacy services’. Community pharmacy was highlighted as an accessible setting for delivering screening and follow-on lifestyle interventions. Key factors for enhancing the capability of community pharmacy teams to deliver the interventions included training and appropriate use of skill mix. Delivering diabetes prevention services in collaboration with general practices was identified as key to the provision of integrated primary care services. Whilst financial incentives were identified as a motivating factor for delivery, service promotion to patients, public and healthcare professionals was perceived as crucial for enhancing engagement. Conclusions: This research highlights a role for community pharmacy in diabetes prevention. New service models should seek to integrate community pharmacy services in primary care to facilitate patient engagement and better communication with general practices

The community pharmacy setting for diabetes prevention: a mixed methods study in people with ‘pre-diabetes’

Background: Diabetes Prevention Programs (DPPs) comprising intensive lifestyle interventions may delay or even prevent the onset of type 2 diabetes in people with pre-diabetes. However, engagement with DPPs is variable with session times and transportation being reported amongst barriers; this may be addressed by community pharmacy (CP) involvement given its recognition for accessibility. Objectives: To explore factors influencing engagement with the National Health Service (NHS) DPP and the role of CP in diabetes prevention.  Methods: Nine hundred and sixty-two questionnaires were posted to people with pre-diabetes identified from five general practices in Norfolk, England between November 2017 and May 2018. Follow-up semi-structured interviews (n = 10) and a focus group (n = 6) were conducted with a sample of questionnaire respondents. Questionnaire data were analysed quantitatively using SPSS and qualitative data analysed inductively using thematic analysis. Themes relating to engagement and the role of CP in pre-diabetes were further analysed using the COM-B model of behaviour change.  Results: A total of 181 (18.8%) questionnaire responses were received, a quarter of whom reported to have either dropped out or declined attending the national DPP. DPP engagers were more likely to report the program location and session times as convenient. Community pharmacy was perceived as an acceptable setting for delivering diabetes prevention services (DPS) and a preferable alternative for regular pharmacy users and people with work and social commitments. Participants felt that opportunity to engage with CP DPS is enhanced by its accessibility and flexibility in making appointments. Knowledge about the DPS provided in CP and previous experience with CP services were central influences of capability and motivation to engage respectively.  Conclusions: This research outlines factors that could influence engagement with community pharmacy-based DPS and provides evidence to inform intervention development. Further research would be required to determine the feasibility and cost-effectiveness of such interventions

Brief education supported psychological treatment for adolescent borderline personality disorder: the BEST feasibility RCT

Background: Borderline personality disorder is a severe mental health condition characterised by a pattern of emotional instability, interpersonal dysfunction, disturbed self-image and impulsive behaviour, including self-harm. Symptoms of borderline personality disorder typically emerge during adolescence. Although there is compelling evidence in support of early intervention for borderline personality disorder, current evidence-based interventions are resource intensive, with the result that few young people access timely treatment. Therefore, there is an urgent need for accessible interventions to facilitate early intervention for adolescents with borderline personality disorder symptoms. Objectives: The first objective was to adapt a brief psychological treatment for adolescent borderline personality disorder that had previously been delivered within secondary mental health services for co-delivery within schools and colleges. The second objective was to assess the feasibility of evaluating the clinical effectiveness and cost-effectiveness of this intervention in a future randomised controlled trial. Design: We first conducted a rapid evidence synthesis of barriers to and facilitators of the implementation of indicated mental health interventions for adolescents within educational settings and piloted the prototype intervention with three schools/colleges. Based on the findings of the evidence synthesis and pilot, we refined the intervention and study procedures in preparation for a feasibility randomised controlled trial. The feasibility randomised controlled trial involved 12 schools and colleges, whose pastoral staff members received training to deliver the intervention alongside a mental health practitioner. Participants were randomised in a 1 : 1 ratio to receive either the BEST (Brief Education Supported Treatment) intervention plus treatment as usual or treatment as usual alone. Participants were assessed pre randomisation (baseline) and at 12 and 24 weeks post randomisation. Mixed-methods process data were collected to understand how the intervention was implemented, to assess acceptability and to monitor contamination of the control arm. Participants: Young people eligible to participate were aged 13–18 years, reported symptoms of borderline personality disorder above an established threshold and had a history of repeated self-harm. Results: The intervention was refined based on findings of the rapid evidence synthesis, which included 50 studies, feedback from staff participants in the pilot and analysis of session recordings. In the feasibility randomised controlled trial, we randomised 32 participants prior to the premature closure of recruitment. The rate of recruitment was slower than anticipated but would probably have narrowly surpassed our progression criterion over the full recruitment window. Participant retention was high (89.5% at 12 weeks and 73.7% at 24 weeks) and the performance of the proposed outcome measures was satisfactory. We did not find any evidence that participants allocated to the treatment-as-usual arm received the BEST intervention or its components. Fidelity of intervention delivery was high (93.5% of recordings rated as adherent) and the intervention was viewed as offering benefits for individual participants, practitioners involved in co-delivery and the wider school/college. Limitations: The feasibility randomised controlled trial was disrupted by the closure of schools and colleges in response to the COVID-19 pandemic. This reduced the window for participant recruitment and limited the data that could be collected. Conclusions: The refined BEST intervention was able to be delivered successfully within schools and colleges and was found to be acceptable to staff and young people. The findings provide support for continuing this programme of research and would inform the design of a future trial

Interpersonal counselling for adolescent depression delivered by youth mental health workers without core professional training: a feasibility randomised controlled trial study protocol.

BACKGROUND: Depression is a common health problem during adolescence and is associated with adverse academic, social and health outcomes. To meet the demand for treatment for adolescent depression, there is a need for evidence-based interventions suitable for delivery outside of specialist Child and Adolescent Mental Health Services (CAMHS). Interpersonal Counselling for Adolescents (IPC-A) is a brief manualised intervention for adolescent depression suitable for delivery by staff who are not qualified health professionals following participation in a brief training course. While initial piloting within Local Authority services has generated promising results, the effectiveness and cost-effectiveness of IPC-A has yet to be established. This study aims to assess the feasibility of a randomised controlled trial (RCT), evaluating the effectiveness and cost-effectiveness of IPC-A delivered by staff without core professional training in comparison to current provision. METHOD: Feasibility RCT with process evaluation using ethnographic methodology. Eligible young people (n = 60) will be randomised in a 1:1 ratio to receive either IPC-A or treatment as usual (TAU). Participants will be assessed pre-randomisation (baseline) and followed up at 5, 10 and 23 weeks post-randomisation. A parallel process evaluation will generate understanding of intervention implementation across services and explore the acceptability of the intervention from the perspective of young people and other key stakeholders. PARTICIPANTS: Young people aged 12-18 years presenting to non-specialist services with symptoms of depression. Youth workers, young people and stakeholders will participate in the process evaluation. DISCUSSION: The need for effective and accessible interventions for young people with mild/sub-threshold depression who, in most cases, do not meet the threshold for mainstream mental health services is long overdue. The primary output of this feasibility trial will be the design of the subsequent full-scale trial. If the results of the current study indicate that this would be feasible, we intend to progress to a multi-site, assessor-blind, superiority RCT of the effectiveness and cost-effectiveness of IPC-A in comparison to TAU for adolescents presenting to non-specialist services with depressive symptoms. If satisfactory solutions to any problems encountered cannot be identified, alternative research designs will be considered. If proven effective, an IPC-A training programme could be implemented. TRIAL REGISTRY: ISRCTN registry, ISRCTN82180413 , Registered 31 December 2019

Doing research in non-specialist mental health services for children and young people:lessons learnt from a process evaluation of the ICALM (Interpersonal Counselling for Adolescent Low Mood) feasibility randomised controlled trial

BACKGROUND: The rising prevalence of adolescent mild depression in the UK and the paucity of evidence-based interventions in non-specialist sectors where most cases present, creates an urgent need for early psychological interventions. Randomised controlled trials (RCTs) are considered the gold standard for obtaining unbiased estimates of intervention effectiveness. However, the complexity of mental health settings poses great challenges for effectiveness evaluations. This paper reports learning from an embedded process evaluation of the ICALM RCT which tested the feasibility of delivering Interpersonal Counselling for Adolescents (IPC-A) plus Treatment as Usual (TAU) versus TAU only for adolescent (age 12-18) mild depression by non-qualified mental health professionals in non-specialist sectors.METHODS: A qualitative mixed methods process evaluation, drawing on Bronfenbrenner's socioecological model to investigate key influences on trial delivery across macro-(e.g. policy), meso-(e.g. service characteristics) and micro-(e.g. on-site trial processes) contextual levels. Data collection methods included 9 site questionnaires, 4 observations of team meetings, policy documents, and 18 interviews with stakeholders including therapists, heads of service and managers. Thematic analysis focused on understanding how contextual features shaped trial implementation.RESULTS: The ICALM trial concluded in 2022 having only randomised 14 out of the target 60 young people. At a macro-level, trial delivery was impacted by the COVID-19 pandemic, with services reporting a sharp increase in cases of (social) anxiety over low mood, and backlogs at central referral points which prolonged waiting times for mild cases (e.g. low mood). An interaction between high demand and lack of capacity at a meso-service level led to low prioritisation of trial activities at a micro-level. Unfamiliarity with research processes (e.g. randomisation) and variation in TAU support also accentuated the complexities of conducting an RCT in this setting.CONCLUSIONS: Conducting a RCT of IPC-A in non-specialist services is not feasible in the current context. Failure to conduct effectiveness trials in this setting has clinical implications, potentially resulting in escalation of mild mental health problems. Research done in this setting should adopt pragmatic and innovative recruitment and engagement approaches (e.g. creating new referral pathways) and consider alternative trial designs, e.g. cluster, stepped-wedge or non-controlled studies using complex systems approaches to embrace contextual complexity.TRIAL REGISTRATION: ISRCTN registry, ISRCTN82180413. Registered on 31 December 2019.</p

Protocol of the process evaluation of cluster randomised control trial for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FluCare)

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

The Reflective Fostering Programme—improving the wellbeing of children in care through a group intervention for foster carers: a randomised controlled trial

Background: The needs of children in care are a government priority, yet the evidence base for effective interventions to support the emotional wellbeing of children in care is lacking. Research suggests that supporting the carer-child relationship, by promoting the carer’s reflective parenting, may be an effective approach to improving the wellbeing of these children. Methods: The study comprises a definitive, superiority, two-armed, parallel, pragmatic, randomised controlled trial, with embedded process evaluation and economic evaluation, and an internal pilot, to evaluate the effectiveness, and cost-effectiveness, of the Reflective Fostering Programme. Randomisation is at the individual level using a 1:1 allocation ratio. The study is being conducted in local authority sites across England, and is targeted at foster carers (including kinship carers) looking after children aged 4 to 13. Consenting participants are randomly allocated to the Reflective Fostering Programme (intervention arm) in addition to usual support or usual support alone (control arm). The primary outcome is behavioural and emotional wellbeing of the child 12 months post-baseline, and secondary outcomes include the following: foster carer’s level of stress, quality of life, reflective capacity, compassion fatigue and burnout, placement stability, the quality of the child-carer relationship, child’s capacity for emotional regulation, and achievement of personalised goals set by the carer. Discussion: A feasibility study has indicated effectiveness of the Programme in improving the child-carer relationship and emotional and behavioural wellbeing of children in care. This study will test the effectiveness and cost-effectiveness of implementing the Reflective Fostering Programme as an additional aid to the support already available to local authority foster carers. Trial registration: ISRCTN 70832140

Cluster randomised control trial protocol for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FLUCARE)

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