SAFETEL randomised controlled feasibility trial of a safety planning intervention with follow-up telephone contact to reduce suicidal behaviour: study protocol

Introduction: There are no evidence-based interventions that can be administered in hospital settings following a general hospital admission after a suicide attempt. Aim: To determine whether a safety planning intervention (SPI) with follow-up telephone support (SAFETEL) is feasible and acceptable to patients admitted to UK hospitals following a suicide attempt. Methods and Analysis: Three-phase development and feasibility study with embedded process evaluation. Phase I comprises tailoring an SPI with telephone follow-up originally designed for veterans in the USA, for use in the UK. Phase II involves piloting the intervention with patients (n=30) who have been hospitalised following a suicide attempt. Phase III is a feasibility randomised controlled trial of 120 patients who have been hospitalised following a suicide attempt with a 6-month follow-up. Phase III participants will be recruited from across four National Health Service hospitals in Scotland and randomised to receive either the SPI with telephone follow-up and treatment as usual (n=80) or treatment as usual only (n=40). The primary outcomes are feasibility outcomes and include the acceptability of the intervention to participants and intervention staff, the feasibility of delivery in this setting, recruitment, retention and intervention adherence as well as the feasibility of collecting the self-harm readmission to hospital outcome data. Statistical analyses will include description of recruitment rates, intervention adherence/use, response rates and estimates of the primary outcome event rates, and intervention effect size (Phase III). Thematic analyses will be conducted on interview and focus group data. Ethics and Dissemination: The East of Scotland Research Ethics Service (EoSRES) approved this study in March 2017 (GN17MH101 Ref: 17/ES/0036). The study results will be disseminated via peer-reviewed publication and conference presentations. A participant summary paper will also be disseminated to patients, service providers and policy makers alongside the main publication. Trial Registration Number: ISRCTN62181241

The Social and Emotional Education and Development intervention to address wellbeing in primary school age children: the SEED cluster RCT

Background: Stronger social and emotional well-being during primary school is positively associated with the health and educational outcomes of young people. However, there is little evidence on which programmes are the most effective for improving social and emotional well-being. Objective: The objective was to rigorously evaluate the Social and Emotional Education and Development (SEED) intervention process for improving pupils’ social and emotional well-being. Design: This was a stratified cluster randomised controlled trial with embedded process and economic evaluations. Thirty-eight primary schools were randomly assigned to the SEED intervention or to the control group. Hierarchical regression analysis allowing for clustering at school learning community level was conducted in R (statistical package). Setting: The SEED intervention is a whole-school intervention; it involved all school staff and two cohorts of pupils, one starting at 4 or 5 years of age and the second starting at 8 or 9 years of age, across all 38 schools. Participants: A total of 2639 pupils in Scotland. Intervention: The SEED intervention used an iterative process that involved three components to facilitate selection and implementation of school-based actions: (1) questionnaire completion, (2) benchmarked feedback to all staff and (3) reflective discussions (all staff and an educational psychologist). Main outcome measure: The primary outcome was pupils’ Strengths and Difficulties Questionnaire-Total Difficulties Score when pupils were 4 years older than at baseline. Results: The primary outcome, pupils’ Strengths and Difficulties Questionnaire-Total Difficulties Score at follow-up 3, showed improvements for intervention arm pupils, compared with those in the control arm [relative risk −1.30 (95% confidence interval −1.87 to −0.73), standardised effect size −0.27 (95% confidence interval −0.39 to −0.15)]. There was no evidence of intervention effects according to deprivation: the results were significant for both affluent and deprived pupils. Subgroup analysis showed that all effect sizes were larger for the older cohort, particularly boys [relative risk −2.36 (95% confidence interval −3.62 to −1.11), standardised effect size −0.42 (95% confidence interval −0.64 to −0.20)]. Although there was no statistically significant difference in incremental cost and quality-adjusted life-years, the probability that the intervention is cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year was high, at 88%. Particularly valued mechanisms of the SEED intervention were its provision of time to reflect on and discuss social and emotional well-being and its contribution to a culture of evaluating practice. Limitations: It was a challenge to retain schools over five waves of data collection. Conclusions: This trial demonstrated that the SEED intervention is an acceptable, cost-effective way to modestly improve pupil well-being and improve school climate, particularly for older boys and those with greater levels of psychological difficulties. It was beneficial during the transition from primary to secondary school, but this diminished after 6 years. The SEED intervention can be implemented alongside existing systems for addressing pupil well-being and can be complementary to other interventions. Future work: Assess whether or not the SEED intervention has a beneficial impact on academic attainment, is transferable to other countries and other organisational settings, would be strengthened by adding core training elements to the intervention process and is transferable to secondary schools. Understand the gender differences illustrated by the outcomes of this trial. Conduct further statistical research on how to handle missing data in longitudinal studies of complex social interventions. Trial registration: This trial is registered as ISRCTN51707384. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 10/3006/13) and is published in full in Public Health Research; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information

A preoperative package of care for osteoarthritis, consisting of weight loss, orthotics, rehabilitation, topical and oral analgesia (OPPORTUNITY): A two centre open label randomised controlled feasibility trial

Background Osteoarthritis of the knee is a major cause of disability worldwide. Non-operative treatments can reduce the morbidity but adherence is poor. We hypothesised that adherence could be optimised if behavioural change was established in the preoperative period. Therefore, we aimed to assess feasibility, acceptability, and recruitment and retention rates of a preoperative package of non-operative care in patients awaiting knee replacement surgery. Methods We did an open-label, randomised controlled, feasibility trial in two secondary care centres in the UK. Eligible participants were aged 15–85 years, on the waiting list for a knee arthroplasty for osteoarthritis, and met at least one of the thresholds for one of the four components of the preoperative package of non-operative care intervention (ie, weight loss, exercise therapy, use of insoles, and analgesia adjustment). Participants were randomly assigned (2:1) to either the intervention group or the standard of care (ie, control) group. All four aspects of the intervention were delivered weekly over 12 weeks. Participants in the intervention group were reviewed regularly to assess adherence. The primary outcome was acceptability and feasibility of delivering the intervention, as measured by recruitment rate, retention rate at follow-up review after planned surgery, health-related quality of life, joint-specific scores, and adherence (weight change and qualitative interviews). This study is registered with ISRCTN, ISRCTN96684272. Findings Between Sept 3 2018, and Aug 30, 2019, we screened 233 patients, of whom 163 (73%) were excluded and 60 (27%) were randomly assigned to either the intervention group (n=40) or the control group (n=20). 34 (57%) of 60 participants were women, 26 (43%) were men, and the mean age was 66·8 years (SD 8·6). Uptake of the specific intervention components varied: 31 (78%) of 40 had exercise therapy, 28 (70%) weight loss, 22 (55%) analgesia adjustment, and insoles (18 [45%]). Overall median adherence was 94% (IQR 79·5–100). At the final review, the intervention group lost a mean of 11·2 kg (SD 5·6) compared with 1·3 kg (3·8) in the control group (estimated difference –9·8 kg [95% CI –13·4 to –6·3]). A clinically significant improvement in health-related quality o life (mean change 0·078 [SD 0·195]) were reported, and joint-specific scores showed greater improvement in the intervention group than in the control group. No adverse events attributable to the intervention occurred. Interpretation Participants adhered well to the non-operative interventions and their health-related quality of life improved. Participant and health professional feedback were extremely positive. These findings support progression to a full-scale effectiveness trial

Supporting emotionally demanding research: developing guidance for a university research centre

No abstract available

A Process Evaluation of the Social and Emotional Education and Development Trial: Case Study Findings

No abstract available

Effectiveness of social network interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease

No abstract available

Is There a Window of Opportunity to Effect Positive Health Behaviour Prior to Surgery? A Two Centre Open Label Randomised Controlled Feasibility Trial of a Preoperative Package of Care for Osteoarthritis, Consisting of Weight Loss, Orthotics, Rehabilitation, Topical and Oral Analgesia (OPPORTUNITY)

Purpose (the aim of the study): Osteoarthritis is a major cause of disability that operative and non-operative treatments can reduce. However, adherence with non-operative treatments is poor. We hypothesised adherence could be optimised if behavioural change was established in the pre-operative period. Thus the aim was to assess the feasibility and acceptability of a pre-operative package of non-operative care. Methods: A two centre randomised controlled feasibility trial of patients awaiting knee arthroplasty:. Participants were randomised (2:1) to the intervention, consisting of (1)weight-loss, (2)exercises, (3)analgesia advice and/or (4)insoles, or usual care. The primary outcome was acceptability and feasibility of delivering the interventions. Recruitment, retention, adherence, weight change, EQ-5D, joint specific scores and qualitative interviews were obtained. Results: Of 233 patients screened, the majority (n=138,62%) were eligible and 43% (60/138) participated (mean age 66.8years [range 48-85], 57% [n=34] female). Physical activity (n=31,78%) was the commonnest component, then weight loss (n=28,70%), analgesia (n=22,55%) and insoles (n=18,45%). Overall median adherence was 94%. The intervention group lost a mean of 11.2kg v 1.3kg in controls. Five (8%) participants cancelled their surgery; 4/5 (10%) were in the intervention arm. There was a clinically significant improvement in EQ-5D for the intervention group (mean change 0.078). Joint specific scores demonstrated greater improvement in the intervention group. Participant and health professional feedback was overwhelmingly positive. Conclusions: Participants welcomed this package of non-operative care, adhered well to it, and had a significant improvement in their health related quality of life(HRQoL). As waiting lists have lengthened, this intervention is particularly timely, as it empowers patients to use the time they are waiting to optimise their health. The findings are particularly exciting as it may be possible to prevent the deterioration in HRQoL on waiting lists and even reverse it. Further, as 10% (4/40) cancelled their surgery the intervention could help address the waiting list crisis

A preoperative package of care for osteoarthritis, consisting of weight loss, orthotics, rehabilitation, topical and oral analgesia (OPPORTUNITY): a two centre open label randomised controlled feasibility trial

BackgroundOsteoarthritis of the knee is a major cause of disability that non-operative treatments can reduce but, adherence is poor. We hypothesised adherence could be optimised if behavioural change was established in the pre-operative period. Thus, the aim was to assess feasibility, acceptability and recruitment/retention rates of a pre-operative package of non-operative care.MethodsA multicentre randomised controlled open label feasibility trial in secondary care of patients awaiting arthroplasty: Participants were randomised (2:1) to the intervention, (consisting of weight-loss, exercise therapy, analgesia advice and/or insoles), or usual care. The primary outcome was acceptability and feasibility of delivering the intervention. Recruitment, retention, adherence, weight change, EQ-5D, joint specific scores and qualitative interviews were obtained.FindingsOf 233 patients screened, the majority (n=138,62%) were eligible and 43% (60/138) participated (mean age 66.8years [range 48-85], 57% [n=34] female). Uptake of the specific interventions varied: physical activity (n=31,78%), weight loss (n=28,70%), analgesia (n=22,55%) and insoles (n=18,45%). Overall median adherence was 94% (interquartile range 79.5%-100%). The intervention group lost a mean of 11.2kg vs 1.3kg in controls (estimated difference -9.8 kg, 95% CI -13.4 to -6.3 kg). Five (8%) participants cancelled their surgery; 4 (10%) were in the intervention arm. There was a clinically significant improvement in EQ-5D (mean change 0.078) and joint specific scores demonstrated greater improvement in the intervention group. No AEs were encountered. Participant and health professional feedback was extremely positive. InterpretationParticipants adhered well to it, and their health-related quality of life (HRQoL) improved. The findings are particularly timely, as the intervention could empower patients to optimise their health while awaiting surgery and prevent the deterioration in HRQoL and even improve it. Progression to a full-scale effectiveness trial is supported. Further, as some patients cancelled their surgery the intervention could help address the waiting list crisis