First contact physiotherapy: an evaluation of clinical effectiveness and costs.

BACKGROUND: First contact physiotherapy practitioners (FCPPs) are embedded within general practice, providing expert assessment, diagnosis, and management plans for patients with musculoskeletal disorders (MSKDs), without the prior need for GP consultation. AIM: To determine the clinical effectiveness and costs of FCPP models compared with GP-led models of care. DESIGN AND SETTING: Multiple site case-study design of general practices in the UK. METHOD: General practice sites were recruited representing the following three models: 1) GP-led care; 2) FCPPs who could not prescribe or inject (FCPPs-standard [St]); and 3) FCPPs who could prescribe and/or inject (FCPPs-additional qualifications [AQ]). Patient participants from each site completed outcome data at baseline, 3 months, and 6 months. The primary outcome was the SF-36 Physical Component Summary (PCS) score. Healthcare usage was collected for 6 months. RESULTS: In total, 426 adults were recruited from 46 practices across the UK. Non-inferiority analysis showed no significant difference in physical function (SF-36 PCS) across all three arms at 6 months (P = 0.667). At 3 months, a significant difference in numbers improving was seen between arms: 54.7% (n = 47) GP consultees, 72.4% (n = 71) FCPP-St, and 66.4% (n = 101) FCPP-AQ (P = 0.037). No safety issues were identified. Following initial consultation, a greater proportion of patients received medication (including opioids) in the GP-led arm (44.7%, n = 42), compared with FCPP-St (18.4%, n = 21) and FCPP-AQ (24.7%, n = 40) (P<0.001). NHS costs (initial consultation and over 6-month follow-up) were significantly higher in the GP-led model (median £105.5 per patient) versus FCPP-St (£41.0 per patient) and FCPP-AQ (£44.0 per patient) (P<0.001). CONCLUSION: FCPP-led models of care provide safe, clinically effective patient management, with cost-benefits and reduced opioid use in this cohort.

A peer support dietary change intervention for encouraging adoption and maintenance of the Mediterranean diet in a non-Mediterranean population (TEAM-MED): lessons learned and suggested improvements.

Peer support interventions for dietary change may offer cost-effective alternatives to interventions led by health professionals. This process evaluation of a trial to encourage the adoption and maintenance of a Mediterranean diet in a Northern European population at high CVD risk (TEAM-MED) aimed to investigate the feasibility of implementing a group-based peer support intervention for dietary change, positive elements of the intervention and aspects that could be improved. Data on training and support for the peer supporters; intervention fidelity and acceptability; acceptability of data collection processes for the trial and reasons for withdrawal from the trial were considered. Data were collected from observations, questionnaires and interviews, with both peer supporters and trial participants. Peer supporters were recruited and trained to result in successful implementation of the intervention; all intended sessions were run, with the majority of elements included. Peer supporters were complimentary of the training, and positive comments from participants centred around the peer supporters, the intervention materials and the supportive nature of the group sessions. Attendance at the group sessions, however, waned over the intervention, with suggested effects on intervention engagement, enthusiasm and group cohesion. Reduced attendance was reportedly a result of meeting (in)frequency and organisational concerns, but increased social activities and group-based activities may also increase engagement, group cohesion and attendance. The peer support intervention was successfully implemented and tested, but improvements can be suggested and may enhance the successful nature of these types of interventions. Some consideration of personal preferences may also improve outcomes.

Association Between Patient Factors and the Effectiveness of Wearable Trackers at Increasing the Number of Steps per Day Among Adults With Cardiometabolic Conditions: Meta-analysis of Individual Patient Data From Randomized Controlled Trials.

BACKGROUND: Current evidence supports the use of wearable trackers by people with cardiometabolic conditions. However, as the health benefits are small and confounded by heterogeneity, there remains uncertainty as to which patient groups are most helped by wearable trackers. OBJECTIVE: This study examined the effects of wearable trackers in patients with cardiometabolic conditions to identify subgroups of patients who most benefited and to understand interventional differences. METHODS: We obtained individual participant data from randomized controlled trials of wearable trackers that were conducted before December 2020 and measured steps per day as the primary outcome in participants with cardiometabolic conditions including diabetes, overweight or obesity, and cardiovascular disease. We used statistical models to account for clustering of participants within trials and heterogeneity across trials to estimate mean differences with the 95% CI. RESULTS: Individual participant data were obtained from 9 of 25 eligible randomized controlled trials, which included 1481 of 3178 (47%) total participants. The wearable trackers revealed that over the median duration of 12 weeks, steps per day increased by 1656 (95% CI 918-2395), a significant change. Greater increases in steps per day from interventions using wearable trackers were observed in men (interaction coefficient -668, 95% CI -1157 to -180), patients in age categories over 50 years (50-59 years: interaction coefficient 1175, 95% CI 377-1973; 60-69 years: interaction coefficient 981, 95% CI 222-1740; 70-90 years: interaction coefficient 1060, 95% CI 200-1920), White patients (interaction coefficient 995, 95% CI 360-1631), and patients with fewer comorbidities (interaction coefficient -517, 95% CI -1188 to -11) compared to women, those aged below 50, non-White patients, and patients with multimorbidity. In terms of interventional differences, only face-to-face delivery of the tracker impacted the effectiveness of the interventions by increasing steps per day. CONCLUSIONS: In patients with cardiometabolic conditions, interventions using wearable trackers to improve steps per day mostly benefited older White men without multimorbidity. TRIAL REGISTRATION: PROSPERO CRD42019143012; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=143012.

The feasibility of a peer support intervention to encourage adoption and maintenance of a Mediterranean diet in established community groups at increased CVD risk: the TEAM-MED EXTEND study: a pilot cluster randomised controlled trial.

This study aimed to evaluate the feasibility of a peer support intervention to encourage adoption and maintenance of a Mediterranean diet (MD) in established community groups where existing social support may assist the behaviour change process. Four established community groups with members at increased Cardiovascular Disease (CVD) risk and homogenous in gender were recruited and randomised to receive either a 12-month Peer Support (PS) intervention (PSG) (n 2) or a Minimal Support intervention (educational materials only) (MSG) (n 2). The feasibility of the intervention was assessed using recruitment and retention rates, assessing the variability of outcome measures (primary outcome: adoption of an MD at 6 months (using a Mediterranean Diet Score (MDS)) and process evaluation measures including qualitative interviews. Recruitment rates for community groups (n 4/8), participants (n 31/51) and peer supporters (n 6/14) were 50 %, 61 % and 43 %, respectively. The recruitment strategy faced several challenges with recruitment and retention of participants, leading to a smaller sample than intended. At 12 months, a 65 % and 76·5 % retention rate for PSG and MSG participants was observed, respectively. A > 2-point increase in MDS was observed in both the PSG and the MSG at 6 months, maintained at 12 months. An increase in MD adherence was evident in both groups during follow-up; however, the challenges faced in recruitment and retention suggest a definitive study of the peer support intervention using current methods is not feasible and refinement based on the current feasibility study should be incorporated. Lessons learned during the implementation of this intervention will help inform future interventions in this area.

A review of the quality and content of mobile apps to support lifestyle modifications following a transient ischaemic attack or 'minor' stroke.

OBJECTIVE: Secondary prevention is recommended to reduce cardiovascular risk after transient ischaemic attack (TIA) or 'minor' stroke. Mobile health interventions can provide accessible, cost-effective approaches to address modifiable risk factors, such as physical inactivity, hypertension and being overweight. The objective of this study was to evaluate the quality of apps for supporting lifestyle change following a TIA or 'minor' stroke. METHODS: Systematic searches of Google Play and the Apple Store were carried out to identify mobile apps released between 1 November 2019 and 1 October 2021. Keywords were used including stroke, TIA, lifestyle, prevention and recovery. Quality was assessed using the Mobile Application Rating Scale (MARS). Common components were identified with the Behaviour Change Technique (BCT) Taxonomy. Descriptive statistics were used to summarize the performance results for each app. RESULTS: Searches identified 2545 potential apps. Thirty remained after removing duplicates and screening titles and descriptions. Six were eligible after full review of their content. All apps included at least one BCT (range: 1-16 BCTs). The most frequent BCTs included 'information about health consequences' (n = 5/6), 'verbal or visual communication from a credible source' (n = 4/6) and 'action planning' (n = 4/6). The mean MARS score was 2.57/5 (SD: 0.51; range: 1.78-3.36). No apps were of 'good' overall quality (scoring more than 4/5). CONCLUSIONS: This is the first review of mobile health interventions for this population. Only a small number of apps were available. None were targeted specifically at people with a TIA or 'minor' stroke. Overall quality was low. Further work is needed to develop and test accessible, user designed, and evidence-informed digital interventions in this population.

Investigating the physical activity, health, wellbeing, social and environmental effects of a new urban greenway: a natural experiment (the PARC study).

BACKGROUND: Evidence for the health benefits of urban green space tends to stem from small, short-term quasi-experimental or cross-sectional observational research, whilst evidence from intervention studies is sparse. The development of an urban greenway (9 km running along 3 rivers) in Northern Ireland provided the opportunity to conduct a natural experiment. This study investigated the public health impact of the urban greenway on a range of physical activity, health, wellbeing, social, and perceptions of the environment outcomes. METHODS: A repeated cross-sectional household survey of adult residents (aged ≥16 years) who lived ≤1-mile radius of the greenway (intervention sample) and > 1-mile radius of the greenway (control sample) was conducted pre (2010/2011) and 6-months post implementation (2016/2017). We assessed changes in outcomes pre- and post-intervention follow-up including physical activity behaviour (primary outcome measure: Global Physical Activity Questionnaire), quality of life, mental wellbeing, social capital and perceptions of the built environment. Linear regression was used to calculate the mean difference between post-intervention and baseline measures adjusting for age, season, education, car ownership and deprivation. Multi-level models were fitted using a random intercept at the super output area (smallest geographical unit) to account for clustering within areas. The analyses were stratified by distance from the greenway and deprivation. We assessed change in the social patterning of outcomes over time using an ordered logit to make model-based outcome predictions across strata. RESULTS: The mean ages of intervention samples were 50.3 (SD 18.9) years at baseline (n = 1037) and 51.7 (SD 19.1) years at follow-up (n = 968). Post-intervention, 65% (adjusted OR 0.60, 95% CI 0.35 to 1.00) of residents who lived closest to the greenway (i.e., ≤400 m) and 60% (adjusted OR, 0.64 95% CI 0.41 to 0.99) who lived furthest from the greenway (i.e.,≥1200 m) met the physical activity guidelines - 68% of the intervention sample met the physical activity guidelines before the intervention. Residents in the most deprived quintiles had a similar reduction in physical activity behaviour as residents in less deprived quintiles. Quality of life at follow-up compared to baseline declined and this decline was significantly less than in the control area (adjusted differences in mean EQ5D: -11.0 (95% CI - 14.5 to - 7.4); - 30.5 (95% CI - 37.9 to - 23.2). Significant change in mental wellbeing was not observed despite improvements in some indicators of social capital. Positive perceptions of the local environment in relation to its attractiveness, traffic and safety increased. CONCLUSIONS: Our findings illustrate the major challenge of evaluating complex urban interventions and the difficulty of capturing and measuring the network of potential variables that influence or hinder meaningful outcomes. The results indicate at this stage no intervention effect for improvements in population-level physical activity behaviour or mental wellbeing. However, they show some modest improvements for secondary outcomes including positive perceptions of the environment and social capital constructs. The public health impact of urban greenways may take a longer period of time to be realised and there is a need to improve evaluation methodology that captures the complex systems nature of urban regeneration.

Development of a Digital Lifestyle Modification Intervention for Use after Transient Ischaemic Attack or Minor Stroke: A Person-Based Approach.

This paper describes the development of the 'Brain-Fit' app, a digital secondary prevention intervention designed for use in the early phase after transient ischaemic attack (TIA) or minor stroke. The aim of the study was to explore perceptions on usability and relevance of the app in order to maximise user engagement and sustainability. Using the theory- and evidence-informed person-based approach, initial planning included a scoping review of qualitative evidence to identify barriers and facilitators to use of digital interventions in people with cardiovascular conditions and two focus groups exploring experiences and support needs of people (N = 32) with a history of TIA or minor stroke. The scoping review and focus group data were analysed thematically and findings were used to produce guiding principles, a behavioural analysis and explanatory logic model for the intervention. Optimisation included an additional focus group (N = 12) and individual think-aloud interviews (N = 8) to explore perspectives on content and usability of a prototype app. Overall, thematic analysis highlighted uncertainty about increasing physical activity and concerns that fatigue might limit participation. Realistic goals and progressive increases in activity were seen as important to improving self-confidence and personal control. The app was seen as a useful and flexible resource. Participant feedback from the optimisation phase was used to make modifications to the app to maximise engagement, including simplification of the goal setting and daily data entry sections. Further studies are required to examine efficacy and cost-effectiveness of this novel digital intervention.

A Systematic Review of Measurement Tools for the Proactive Assessment of Patient Safety in General Practice.

BACKGROUND: Primary care physicians have reported a difficulty in understanding how best to measure and improve patient safety in their practices. OBJECTIVES: The aims of the study were to identify measures of patient safety suitable for use in primary care and to provide guidance on proactively monitoring and measuring safety. METHODS: Searches were conducted using Medline, Embase, CINAHL and PsycInfo in February 2016. Studies that used a measure assessing levels of or attitudes toward patient safety in primary care were considered for inclusion. Only studies describing tools focused on the proactive assessment of safety were reviewed. Two independent reviewers extracted data from articles and applied the Quality Assessment Tool for Studies with Diverse Designs. RESULTS: More than 2800 studies were screened, of which 56 were included. Most studies had used healthcare staff survey or interviews to assess patient safety (n = 34), followed by patient chart audit (n = 14) or use of a practice assessment checklist (n = 7). Survey or interview of patients, active monitoring systems, and simulated patients were used with less frequency. CONCLUSIONS: A lack of appropriate measurement tools has been suggested to limit the ability to monitor patient safety in primary care and to improve patient care. There is no evident "best" method of measuring patient safety in primary care. However, many of the measures are readily available, quick to administer, do not require external involvement, and are inexpensive. This synthesis of the literature suggests that it is possible for primary care physicians to take a proactive approach to measuring and improving safety.

Usability and Acceptability of a Novel Secondary Prevention Initiative Targeting Physical Activity for Individuals after a Transient Ischaemic Attack or "Minor" Stroke: A Qualitative Study.

Behavioural interventions that address cardiovascular risk factors such as physical inactivity and hypertension help reduce recurrence risk following a transient ischaemic attack (TIA) or "minor" stroke, but an optimal approach for providing secondary prevention is unclear. After developing an initial draft of an innovative manual for patients, aiming to promote secondary prevention following TIA or minor stroke, we aimed to explore views about its usability and acceptability amongst relevant stakeholders. We held three focus group discussions with 18 participants (people who had experienced a TIA or minor stroke (4), carers (1), health professionals (9), and researchers (4). Reflexive thematic analysis identified the following three inter-related themes: (1) relevant information and content, (2) accessibility of format and helpful structure, and (3) strategies to optimise use and implementation in practice. Information about stroke, medication, diet, physical activity, and fatigue symptoms was valued. Easily accessed advice and practical tips were considered to provide support and reassurance and promote self-evaluation of lifestyle behaviours. Suggested refinements of the manual's design highlighted the importance of simplifying information and providing reassurance for patients early after a TIA or minor stroke. Information about fatigue, physical activity, and supporting goal setting was viewed as a key component of this novel secondary prevention initiative.

Provision of first contact physiotherapy in primary care across the UK: a survey of the service.

BACKGROUND: First Contact Physiotherapy (FCP) is an emerging model of care whereby a specialist physiotherapist located within general practice undertakes the first patient assessment, diagnosis and management without a prior GP consultation. Despite institutional and professional body support for this model and NHS commitment to its implementation, data regarding current FCP provision are limited. OBJECTIVES: To identify current FCP service provision across the UK, including models of provision and key professional capabilities. DESIGN: Cross-sectional online survey, targeting physiotherapists and service managers involved in FCP. METHODS: Recruitment involved non-probability sampling targeting those involved in FCP service provision through emails to members of known clinical networks, snowballing and social media. The survey gathered data about respondents, FCP services and the role and scope of physiotherapists providing FCP. RESULTS: The authors received 102 responses; 32 from service managers and 70 working in FCP practice from England (n=60), Scotland (n=22), Wales (n=14), and Northern Ireland (n=2). Most practitioners were NHS band 7 or 8a (91%, n=63), with additional skills (e.g. requesting investigations, prescribing). 17% (12/70) worked 37.5hours/week; 37% (26/70) ≤10hours; most (71%, 50/70) used 20-minute appointments (range 10-30minutes); varying arrangements were reported for administration and follow-up. Services covered populations of 1200 to 600,000 (75% <100,000); access mostly involved combinations of self-booking and reception triage. Commissioning and funding arrangements varied widely; NHS sources provided 90% of services. CONCLUSIONS: This survey provides new evidence regarding variation in FCP practice across the UK, indicating that evidence-informed, context specific guidance on optimal models of provision is required.

Implementing community-based health promotion in socio-economically disadvantaged areas: a qualitative study.

BACKGROUND: There is a gradient relationship between socio-economic status and health. We investigated the views and perceptions of health promotion service providers regarding factors that affect lack of engagement in public health initiatives by residents in socio-economically disadvantaged (SED) communities. METHODS: We conducted semi-structured interviews with a purposive sample of key providers (n = 15) of community-based health promotion services to elicit their views about engagement-related factors and their experiences of the provision, delivery and impact of health promotion in SED areas. Interviews were analysed using thematic analysis. RESULTS: Failure to (i) recognise within SED communities, socio-cultural norms of health-related behaviour and (ii) communicate to local residents an understanding of complex lifestyle influences appeared to affect adversely service engagement and contribute to the development of negative attitudes towards health promotion. Engagement is more likely when services are delivered within familiar settings, peer support is available, initiatives are organized within existing groups, external incentives are offered and there are options regarding times and locations. Collaborative working between providers and communities facilitates efficient, context-sensitive service delivery. CONCLUSIONS: Knowledge of a local community and its socio-environmental context alongside a collaborative, facilitative and tailored approach to delivery are required to ensure successful engagement of SED communities in health promotion.

A feasibility study of 'The StepSmart Challenge' to promote physical activity in adolescents.

BACKGROUND: Inactive lifestyles are becoming the norm and creative approaches to encourage adolescents to be more physically active are needed. Little is known about how gamification techniques can be used in physical activity interventions for young people. Such approaches may stimulate interest and encourage physical activity behaviour. The study investigated the feasibility of implementing and evaluating a physical activity intervention for adolescents which included gamification techniques within schools. We tested recruitment and retention strategies for schools and participants, the use of proposed outcome measures, and explored intervention acceptability. METHODS: This school-based feasibility study of a randomised cluster trial recruited adolescents aged 12-14 years (n = 224) from five schools (three intervention; two control) in Belfast, Northern Ireland. The 22-week intervention (The StepSmart Challenge) informed by self-determination theory and incorporating gamification strategies involved a school-based pedometer competition. Outcomes, measured at baseline, and post-intervention (at 22 weeks post-baseline and 52 weeks post-baseline) included daily minutes of moderate to vigorous physical activity (MVPA) (measured using ActiGraph accelerometer), mental wellbeing (Warwick-Edinburgh Mental Wellbeing Scale), social support for physical activity, time preference (for delayed and larger rewards or immediate and smaller rewards), pro-social behaviour (Strengths and Difficulties Questionnaire (SDQ)) and the influence of social networks. The intervention's acceptability was explored in focus groups. RESULTS: We invited 14 schools to participate; eight showed interest in participating. We recruited the first five who responded; all five completed the trial. Of the 236 pupils invited, 224 participated (94.9%): 84.8% (190/224) provided valid MVPA (minutes/day) at baseline and 57.2% (123/215) at 52 weeks. All other outcomes were well completed apart from the SDQ (65% at baseline). Qualitative data highlighted that participants and teachers found The StepSmart Challenge to be an acceptable intervention. CONCLUSIONS: The level of interest and high recruitment and retention rates provide support for the feasibility of this trial. The intervention, incorporating gamification strategies and the recruitment methods, using parental opt-out procedures, were acceptable to participants and teachers. Teachers also suggested that the implementation of The StepSmart Challenge could be embedded in a lifelong learning approach to health within the school curriculum. As young people's lives become more intertwined with technology, the use of innovative gamified interventions could be one approach to engage and motivate health behavioural change in this population. TRIAL REGISTRATION: NCT02455986 (date of registration: 28 May 2015).

Rehabilitation of patients after transient ischaemic attack or minor stroke: pilot feasibility randomised trial of a home-based prevention programme.

BACKGROUND: Although the importance of secondary prevention after transient ischaemic attack (TIA) or minor stroke is recognised, research is sparse regarding novel, effective ways in which to intervene in a primary care context. AIM: To pilot a randomised controlled trial (RCT) of a novel home-based prevention programme (The Healthy Brain Rehabilitation Manual) for patients with TIA or 'minor' stroke. DESIGN AND SETTING: Pilot RCT, home-based, undertaken in Northern Ireland between May 2017 and March 2018. METHOD: Patients within 4 weeks of a first TIA or 'minor' stroke received study information from clinicians in four hospitals. Participants were randomly allocated to one of three groups: standard care (control group) (n = 12); standard care with manual and GP follow-up (n = 14); or standard care with manual and stroke nurse follow-up (n = 14). Patients in all groups received telephone follow-up at 1, 4, and 9 weeks. Eligibility, recruitment, and retention were assessed; stroke/cardiovascular risk factors measured at baseline and 12 weeks; and participants' views were elicited about the study via focus groups. RESULTS: Over a 32-week period, 28.2% of clinic attendees (125/443) were eligible; 35.2% of whom (44/125) consented to research contact; 90.9% of these patients (40/44) participated, of whom 97.5% (39/40) completed the study. After 12 weeks, stroke risk factors [cardiovascular risk factors, including blood pressure and measures of physical activity] improved in both intervention groups. The research methods and the programme were acceptable to patients and health professionals, who commented that the programme 'filled a gap' in current post-TIA management. CONCLUSION: Findings indicate that implementation of this novel cardiac rehabilitation programme, and of a trial to evaluate its effectiveness, is feasible, with potential for clinically important benefits and improved secondary prevention after TIA or 'minor' stroke.

Promoting physical activity among community groups of older women in socio-economically disadvantaged areas: randomised feasibility study.

BACKGROUND: Insufficient physical activity (PA) is a major public health issue. Whilst PA is an important contributor to disease prevention, engagement in PA decreases with age, particularly among women in socio-economically disadvantaged areas. Research using existing support networks to engage 'hard to reach' populations in PA interventions is sparse. We developed and tested the feasibility of a PA-promoting intervention for older women within existing community groups in socio-economically disadvantaged areas. METHODS: The Medical Research Council guidelines for complex interventions were used to guide the intervention's development. We recruited participants (n = 40) from older (aged ≥50 years) women's groups from four different community centres. A 12-week programme was delivered during existing sessions, informed by Social Practice Theory. The sessions provided education about PA, social support in the form of a PA 'buddy', group discussion and follow-up telephone calls, as well as printed information about local opportunities to participate in PA. The main uncertainties tested were rates of participant recruitment, retention, and completion of assessments of PA by accelerometry and of mental health using the Hospital Anxiety and Depression Scale (HADS). Intervention acceptability was assessed by questionnaire, and focus group interviews elicited participants' views about the intervention. Qualitative data were subjected to framework analysis. RESULTS: The recruitment rate was high; 87% (n = 40/46) of women consented to participate, and 78% (n = 31) attended all education sessions. Uptake of follow-up telephone calls and PA 'buddies' was low. Few participants provided valid accelerometer data, but 63% (n=25) completed the HADS questionnaire at all time points. The printed materials and education sessions were viewed positively; telephone calls and 'buddy' support were not valued. Participants believed that organised group activities would lead to increased PA engagement, and whilst participants disliked wearing a waist accelerometer, they thought that regular PA feedback would facilitate necessary goal-setting. CONCLUSIONS: High recruitment and retention rates suggest that use of existing social support groups is an acceptable and attractive method of delivering a PA intervention to this population. A randomised controlled trial of the intervention appears feasible, but its design requires refinement of the social support component, facilitation of goal-setting and reconsideration of the assessment of PA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02880449 . Registered on 26 August 2016.

Safety in primary care (SAP-C): a randomised, controlled feasibility study in two different healthcare systems.

BACKGROUND: Patient safety research is conducted predominantly in hospital settings, with a dearth of insight from primary care, despite suggestions that 2.2% of primary care consultations result in a patient safety incident. This study aimed to assess the feasibility of an intervention intended to improve patient safety in general practice. METHODS: A randomised controlled feasibility study was conducted with general practices in the Republic of Ireland (N = 9) and Northern Ireland (N = 2), randomly assigned to the intervention (N = 5) or control (N = 6) group. The nine-month intervention consisted of: 1) repeated safety climate (SC) measurement (using GP-SafeQuest questionnaire) and feedback (comparative anonymised practice-level SC data), and 2) patient record reviews using a specialised trigger tool to identify instances of undetected patient harm. For control practices, SC was measured at baseline and study end only. The intervention's perceived usefulness and feasibility were explored via an end-of-study questionnaire and semi-structured interviews. RESULTS: Thirteen practices were invited; 11 participated; 10 completed the study. At baseline, 84.8% of intervention practice staff (39/46) and 77.8% (42/54) of control practice staff completed the SC questionnaire; at the study terminus, 78.3% (36/46) of intervention practice staff and 68.5% (37/54) of control practice staff did so. Changes in SC scores, indicating improvement, were observed among the intervention practices but not in the control group. The trigger tool was applied to 188 patient records; patient safety incidents of varying severity were detected in 19.1% (36/188). Overall, 59% of intervention practice team members completed the end-of-study questionnaire, with the majority in both healthcare systems responding positively about the intervention. Interviews (N = 9) identified the intervention's usefulness in informing practice management and patient safety issues, time as a barrier to its use, and the value of group discussion of feedback. CONCLUSION: This feasibility study suggests that a definitive randomised controlled trial of the intervention is warranted. Our findings suggest that the intervention is feasible, useful, and sustainable. Practices were willing to be recruited into the study, response and retention rates were acceptable, and there is possible evidence of a positive effect of the intervention. TRIAL REGISTRATION: The trial registration number is: ISRCTN11426121 (retrospectively registered 12th June 2018).

Shared decision-making (SHARE-D) for healthy behaviour change: a feasibility study in general practice.

BACKGROUND: Effective interventions are needed to support health behaviour change for cardiovascular disease (CVD) prevention. Decision tools encourage behaviour change but their effectiveness when used in shared decision-making with health professionals (HPs) is unknown. AIM: To test the feasibility of using a novel, paper-based tool for shared decision-making in initiating behaviour change. DESIGN & SETTING: A feasibility study in five general practices in Northern Ireland. METHOD: Adults with, or at high risk of, CVD were invited to discuss their diet and physical activity (PA) with an HP. Using a paper-based decision aid in shared decision-making about behaviour change, their capabilities, opportunities, and motivation were considered. Diet and PA were assessed at baseline, 1, and 3 months using the Dietary Instrument for Nutritional Education (DINE) and the Recent Physical Activity Questionnaire (RPAQ); accelerometers measured PA at baseline and 3 months. Semi-structured interviews, analysed thematically, explored participants' and HPs' views of the process. RESULTS: The positive response rate to study invitation was 28% (45/162); 23 were recruited (aged 43-74 years; 50% male; <40% met diet or PA recommendations); and 87% (20/23) completed the study. All interviewees valued the tool's structure, succinct content, and facilitation of discussion. HPs' sharing of relevant personal experience encouraged behaviour change; social responsibilities, health conditions, and beliefs restricted change. HPs' workloads prohibited the tool's routine use. CONCLUSION: Recruitment and completion rates suggest that using a novel, paper-based tool in shared decision-making for behaviour change is feasible. HPs' workloads constrain its use in practice, but qualitative findings indicate its potential value. Cross-sector collaborative exploration of sustainable models to promote behaviour change is needed.

Development of a peer support intervention to encourage dietary behaviour change towards a Mediterranean diet in adults at high cardiovascular risk.

BACKGROUND: Mediterranean diet (MD) interventions are demonstrated to significantly reduce cardiovascular disease (CVD) risk but are typically resource intensive and delivered by health professionals. There is considerable interest to develop interventions that target sustained dietary behaviour change and that are feasible to scale-up for wider public health benefit. The aim of this paper is to describe the process used to develop a peer support intervention to encourage dietary behaviour change towards a MD in non-Mediterranean adults at high CVD risk. METHODS: The Medical Research Council (MRC) and Behaviour Change Wheel (BCW) frameworks and the COM-B (Capability, Opportunity, Motivation, Behaviour) theoretical model were used to guide the intervention development process. We used a combination of evidence synthesis and qualitative research with the target population, health professionals, and community health personnel to develop the intervention over three main stages: (1) we identified the evidence base and selected dietary behaviours that needed to change, (2) we developed a theoretical basis for how the intervention might encourage behaviour change towards a MD and selected intervention functions that could drive the desired MD behaviour change, and (3) we defined the intervention content and modelled outcomes. RESULTS: A theory-based, culturally tailored, peer support intervention was developed to specifically target behaviour change towards a MD in the target population. The intervention was a group-based program delivered by trained peer volunteers over 12-months, and incorporated strategies to enhance social support, self-efficacy, problem-solving, knowledge, and attitudes to address identified barriers to adopting a MD from the COM-B analysis. CONCLUSIONS: The MRC and BCW frameworks provided a systematic and complementary process for development of a theory-based peer support intervention to encourage dietary behaviour change towards a MD in non-Mediterranean adults at high CVD risk. The next step is to evaluate feasibility, acceptability, and diet behaviour change outcomes in response to the peer support intervention (change towards a MD and nutrient biomarkers) using a randomized controlled trial design.