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.

The Reflective Fostering Programme-Adapting a group parenting programme for online delivery in response to the COVID-19 pandemic in the United Kingdom.

OBJECTIVE: In the context of the Covid-19 pandemic and subsequent lockdown restrictions, service providers faced significant challenges in delivering programmes to support their vulnerable service users. Foster carers-an already often isolated group of caregivers - were offered an adapted remote-delivery model of the Reflective Fostering Programme (Redfern et al., Adopt. Foster., 42, 2018, 234) from March 2020. METHOD: This paper outlines the adaptation process of the original programme to online-remote delivery and describes the feedback from participants in the programme. RESULTS: The adaptation of the Reflective Fostering programme to online, remote delivery had both strengths and weaknesses - including wider access to foster carers who might struggle to attend in person and challenge a to maintaining a Mentalizing space online and ensuring confidentiality within a therapeutic space. The programme was overwhelmingly well received by foster carers in this format. CONCLUSIONS: There are opportunities and challenges in the delivery of online therapeutic services, particularly those with a group format. This paper contributes initial reflections to what we hope will be a rapidly developing literature on best practice of supporting group services in an online format.

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. TRIAL REGISTRATION: ISRCTN ISRCTN22729870. Registered on 24 August 2022.

Theory-informed strategies to address factors anticipated to influence implementation and people's participation in community pharmacy-based diabetes prevention services.

Background: Early identification of non-diabetic hyperglycaemia and implementation of diet and lifestyle changes can prevent type 2 diabetes. However, low participation in diabetes prevention services remains a problem in the UK. The community pharmacy, one of the most accessible healthcare settings in the UK, could provide one solution to improving participation. Aim: To prioritize factors that could influence delivery of, and people-participation in, community pharmacy-based diabetes prevention services, and to identify strategies to facilitate successful implementation. Methods: A mixed-methods, primary care-based study, comprising of two stages: 1- Prioritizing key influences of participation and delivery using a structured Nominal Group Technique with people with non-diabetic hyperglycemia, and other stakeholders; 2 - Identifying theory informed strategies to facilitate successful implementation using framework analysis. This involved mapping prioritized influences and qualitative data from the Nominal Group Technique onto the Behaviour Change Wheel theoretical framework. The study was conducted in February 2019, in Norfolk, UK and ethical approval obtained prior to research commencing. Results: Fifteen participants (five people with non-diabetic hyperglycaemia, nine community pharmacy and general practice staff and one commissioner) participated. Participants prioritized "awareness" and "service integration" as key factors likely to influence participation and "the provision of information about health consequences e.g., leaflets" and "action planning e.g. general practice referral of patients to prevention services" as key strategies to facilitate participation. "Training", "staffing levels" and "workload" were amongst the key factors prioritized as most likely to influence delivery. Strategies identified to facilitate implementation included "instructions of how to perform the behaviour e.g. standard operating procedures" and "reward e.g. funding". Conclusions: This research provides theory informed strategies needed to facilitate successful implementation of community pharmacy-based diabetes prevention services. The findings of this study should inform the design of future diabetes prevention services to ensure participation and sustainability.

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.

Patient feedback on hospital pharmacists' consultation skills: A feasibility study using the Interpersonal Skills Questionnaire (ISQ).

BACKGROUND: Improvement in practitioners' consultation skills (CSs) can be driven by patient feedback, however, to date, no study has been conducted with reference to pharmacy consultations. The Interpersonal Skills Questionnaire (ISQ) is potentially appropriate for collecting patient feedback on pharmacists' CSs. This study aims to explore the feasibility of collecting patient feedback on hospital pharmacists' CSs using the ISQ, to identify the acceptability of the feedback process, and to identify methods to enhance the process in the future. METHODS: The study was conducted in a teaching hospital, United Kingdom, between 2018 and 2019. A diverse sample of pharmacists with patient-facing roles was purposively selected. The study comprised three phases. Pharmacists collected feedback from patients following their consultation using the ISQ utilising a third person whenever possible (phase-1). Data analysis and individual report writing was conducted by a private company. Interviewing a sample of patient participants by telephone (phase-2), and interviewing pharmacists face-to-face after receiving feedback reports (phase-3). All interviews were transcribed verbatim and thematically analysed. The study received approval by the NHS Health Research Authority. RESULTS: Six pharmacists were included. Of the 119 distributed ISQs, 111 were returned (response rate 93%). Patients were mostly recruited by their consulting pharmacists (72%, n = 80). All pharmacists and 14 patients were interviewed. Participants were positive about patient feedback and its role in enhancing CSs. Most did not encounter any problem with the process, however, some pharmacists struggled to find a third person. The ISQ was mostly viewed suitable to assessing pharmacy consultations. Some reports highlighted areas to improve (e.g. protecting patient's privacy). CONCLUSIONS: Collecting feedback is feasible, acceptable and may enhance CSs, however, the process was associated with challenges such as finding a third person. Several measures should be considered to make the process more feasible within the hospital pharmacy setting.

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 .

Exploring the views of community pharmacists on patient feedback on their consultations.

OBJECTIVES: To explore community pharmacists' (CPs) views on patient feedback on their consultations. METHODS: The study was conducted at community pharmacies in the East of England. Pharmacists employed at a large multiple pharmacy were invited to a telephone/face-to-face interview. Interviews were audio-recorded and thematically analysed. KEY FINDINGS: Six pharmacists participated and interviews yielded four main themes. Pharmacists shared views on benefits of collecting feedback (e.g. improving their consultations), potential barriers (e.g. bias) and associated resolutions (e.g. using anonymous questionnaires). Peer feedback was also suggested. CONCLUSIONS: Patient feedback is welcomed by CPs and perceived useful for improving their consultations.