Evaluation of a complex intervention for prisoners with common mental health problems, near to and after release: the Engager randomised controlled trial.

BACKGROUND: Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with homelessness and substance misuse. AIMS: This study aims to evaluate whether the Engager intervention improves mental health outcomes following release. METHOD: The design is a parallel randomised superiority trial that was conducted in the North West and South West of England (ISRCTN11707331). Men serving a prison sentence of 2 years or less were individually allocated 1:1 to either the intervention (Engager plus usual care) or usual care alone. Engager included psychological and practical support in prison, on release and for 3-5 months in the community. The primary outcome was the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), 6 months after release. Primary analysis compared groups based on intention-to-treat (ITT). RESULTS: In total, 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1.1, 95% CI -1.1 to 3.2, P = 0.325) or secondary analyses. There were no consistent clinically significant between-group differences for secondary outcomes. Full delivery was not achieved, with 77% (108/140) receiving community-based contact. CONCLUSIONS: Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not shown to be effective using standard outcome measures. Further testing of different support strategies for prison with mental health problems is needed.

Acceptability of, and barriers and facilitators to, a pilot physical health service for people who inject drugs: A qualitative study with service users and providers.

BACKGROUND: People who inject drugs may experience difficulty accessing or maintaining involvement with traditional healthcare services. This is associated with increased health inequalities and bio-psychosocial difficulties. Embedding physical healthcare services within community-based drug services may provide a practical and feasible approach to increase access and delivery of healthcare. This study explored the acceptability of, and barriers and facilitators to, embedding a pilot physical healthcare service within a community-based drug service in the United Kingdom (Bristol, England). METHODS: Semi-structured interviews were conducted with service users (people who inject drugs) (n = 13), and a focus group was conducted with service providers (n = 11: nine harm reduction workers, two nurses, one service manager). Topic guides included questions to explore barriers and facilitators to using and delivering the service (based on the COM-B Model), and acceptability of the service (using the Theoretical Framework of Acceptability). Transcripts were analysed using a combined deductive framework and inductive thematic analysis approach. RESULTS: The service was viewed as highly acceptable. Service users and providers were confident they could access and provide the service respectively, and perceived it to be effective. Barriers included competing priorities of service users (e.g. drug use) and the wider service (e.g. equipment), and the potential impact of the service being removed in future was viewed as a barrier to overall healthcare access. Both service users and providers viewed embedding the physical health service within an existing community-based drug service as facilitating accessible and holistic care which reduced stigma and discrimination. CONCLUSIONS: The current study demonstrated embedding a physical health service within an existing community-drug based and alcohol service was acceptable and beneficial. Future studies are required to demonstrate cost-effectiveness and ensure long-term sustainability, and to determine transferability of findings to other settings, organisations and countries.

The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel.

AIMS: Self-management programmes for type 1 diabetes, such as the UK's Dose Adjustment for Normal Eating (DAFNE), improve short-term clinical outcomes but difficulties maintaining behavioural changes attenuate long-term impact. This study used the Behaviour Change Wheel (BCW) framework to revise the DAFNE intervention to support sustained behaviour change. METHODS: A four-step method was based on the BCW intervention development approach: (1) Identifying self-management behaviours and barriers/enablers to maintain them via stakeholder consultation and evidence synthesis, and mapping barriers/enablers to the Capability, Opportunity, Motivation-Behaviour (COM-B) model. (2) Specifying behaviour change techniques (BCTs) in the existing DAFNE intervention using the Behaviour Change Techniques Taxonomy (BCTTv1). (3) Identifying additional BCTs to target the barriers/enablers using the BCW and BCTTv1. (4) Parallel stakeholder consultation to generate recommendations for intervention revision. Revised materials were co-designed by stakeholders (diabetologists, psychologists, specialist nurses and dieticians). RESULTS: In all, 34 barriers and 5 enablers to sustaining self-management post-DAFNE were identified. The existing DAFNE intervention contained 24 BCTs, which partially addressed the enablers. In all, 27 BCTs were added, including 'Habit formation', 'Credible source' and 'Conserving mental resources'. In total, 15 stakeholder-agreed recommendations for content and delivery were incorporated into the final DAFNEplus intervention, comprising three co-designed components: (1) face-to-face group learning course, (2) individual structured follow-up sessions and (3) technological support, including blood glucose data management. CONCLUSIONS: This method provided a systematic approach to specifying and revising a behaviour change intervention incorporating stakeholder input. The revised DAFNEplus intervention aims to support the maintenance of behavioural changes by targeting barriers and enablers to sustaining self-management behaviours.

Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial.

OBJECTIVE: The HOME BP (Home and Online Management and Evaluation of Blood Pressure) trial aimed to test a digital intervention for hypertension management in primary care by combining self-monitoring of blood pressure with guided self-management. DESIGN: Unmasked randomised controlled trial with automated ascertainment of primary endpoint. SETTING: 76 general practices in the United Kingdom. PARTICIPANTS: 622 people with treated but poorly controlled hypertension (>140/90 mm Hg) and access to the internet. INTERVENTIONS: Participants were randomised by using a minimisation algorithm to self-monitoring of blood pressure with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner; 317 participants). The digital intervention provided feedback of blood pressure results to patients and professionals with optional lifestyle advice and motivational support. Target blood pressure for hypertension, diabetes, and people aged 80 or older followed UK national guidelines. MAIN OUTCOME MEASURES: The primary outcome was the difference in systolic blood pressure (mean of second and third readings) after one year, adjusted for baseline blood pressure, blood pressure target, age, and practice, with multiple imputation for missing values. RESULTS: After one year, data were available from 552 participants (88.6%) with imputation for the remaining 70 participants (11.4%). Mean blood pressure dropped from 151.7/86.4 to 138.4/80.2 mm Hg in the intervention group and from 151.6/85.3 to 141.8/79.8 mm Hg in the usual care group, giving a mean difference in systolic blood pressure of -3.4 mm Hg (95% confidence interval -6.1 to -0.8 mm Hg) and a mean difference in diastolic blood pressure of -0.5 mm Hg (-1.9 to 0.9 mm Hg). Results were comparable in the complete case analysis and adverse effects were similar between groups. Within trial costs showed an incremental cost effectiveness ratio of £11 ($15, €12; 95% confidence interval £6 to £29) per mm Hg reduction. CONCLUSIONS: The HOME BP digital intervention for the management of hypertension by using self-monitored blood pressure led to better control of systolic blood pressure after one year than usual care, with low incremental costs. Implementation in primary care will require integration into clinical workflows and consideration of people who are digitally excluded. TRIAL REGISTRATION: ISRCTN13790648.

Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: a lifelong approach to promote effective self-management in adults with type 1 diabetes.

INTRODUCTION: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment For Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short term (manifest by falls in glycated haemoglobin, HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behavioural change techniques, technology and longer-term structured support from healthcare professionals (HCPs). METHODS AND ANALYSIS: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in National Health Service secondary care hospitals in the UK. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation. ETHICS AND DISSEMINATION: Ethics approval was granted by South West-Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14 May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals. TRIAL REGISTRATION NUMBER: ISRCTN42908016.

Effectiveness of training stop-smoking advisers to deliver cessation support to the UK national proposed standard versus usual care in Malaysia: a two-arm cluster-randomized controlled trial.

AIMS: To assess the effectiveness of training stop smoking services providers in Malaysia to deliver support for smoking cessation based on the UK National Centre for Smoking Cessation and Training (NCSCT) standard treatment programme compared with usual care. DESIGN: Two-arm cluster-randomized controlled effectiveness trial across 19 sites with follow-up at 4-week, 3-month, and 6-month. SETTING: Stop smoking services operating in public hospitals in Malaysia. PARTICIPANTS: Five hundred and two smokers [mean ± standard deviation (SD), age 45.6 (13.4) years; 97.4% male] attending stop smoking services in hospital settings in Malaysia: 330 in 10 hospitals in the intervention condition and 172 in nine hospitals in the control condition. INTERVENTION AND COMPARATOR: The intervention consisted of training stop-smoking practitioners to deliver support and follow-up according to the NCSCT Standard Treatment Programme. The comparator was usual care (brief support and follow-up). MEASUREMENTS: The primary outcome was continuous tobacco smoking abstinence up to 6 months in smokers who received smoking cessation treatment, verified by expired-air carbon monoxide (CO) concentration. Secondary outcomes were continuous CO-verified tobacco smoking abstinence up to 4 weeks and 3 months. RESULTS: Follow-up rates at 4 weeks, 3 months and 6 months were 80.0, 70.6 and 53.3%, respectively, in the intervention group and 48.8, 30.8 and 23.3%, respectively, in the control group. At 6-month follow-up, 93 participants in the intervention group and 19 participants in the control group were abstinent from smoking, representing 28.2 versus 11.0% in an intention-to-treat (ITT) analysis assuming that participants with missing data had resumed smoking, and 52.8 versus 47.5% in a follow-up-only (FUO) analysis. Unadjusted odds ratios (accounting for clustering) were 5.04, (95% confidence interval (CI) = 1.22-20.77, P = 0.025) and 1.70, (95% CI = 0.25-11.53, P = 0.589) in the ITT and FUO analyses, respectively. Abstinence rates at 4 week and 3 month follow-ups were significantly higher in the intervention versus control group in the ITT but not the FUO analysis. CONCLUSIONS: On an intention-to-treat analysis with missing-equals-smoking imputation, training Malaysian stop smoking service providers in the UK National Centre for Smoking Cessation and Training standard treatment programme appeared to increase 6 month continuous abstinence rates in smokers seeking help with stopping compared with usual care. However, the effect may have been due to increasing follow-up rates.

The CUSSH programme: supporting cities' transformational change towards health and sustainability.

This paper describes a global research programme on the complex systemic connections between urban development and health. Through transdisciplinary methods the Complex Urban Systems for Sustainability and Health (CUSSH) project will develop critical evidence on how to achieve the far-reaching transformation of cities needed to address vital environmental imperatives for planetary health in the 21st Century. CUSSH's core components include: (i) a review of evidence on the effects of climate actions (both mitigation and adaptation) and factors influencing their implementation in urban settings; (ii) the development and application of methods for tracking the progress of cities towards sustainability and health goals; (iii) the development and application of models to assess the impact on population health, health inequalities, socio-economic development and environmental parameters of urban development strategies, in order to support policy decisions; (iv) iterative in-depth engagements with stakeholders in partner cities in low-, middle- and high-income settings, using systems-based participatory methods, to test and support the implementation of the transformative changes needed to meet local and global health and sustainability objectives; (v) a programme of public engagement and capacity building. Through these steps, the programme will provide transferable evidence on how to accelerate actions essential to achieving population-level health and global climate goals through, amongst others, changing cities' energy provision, transport infrastructure, green infrastructure, air quality, waste management and housing.

Evaluating the effectiveness of the smartphone app, Drink Less, compared with the NHS alcohol advice webpage, for the reduction of alcohol consumption among hazardous and harmful adult drinkers in the UK at 6-month follow-up: protocol for a randomised controlled trial.

BACKGROUND AND AIMS: Digital interventions are effective for reducing alcohol consumption but evidence is limited regarding smartphone apps. Drink Less is a theory- and evidence-informed app to help people reduce their alcohol consumption that has been refined in terms of its content and design for usability across the sociodemographic spectrum. We aim to evaluate the effectiveness and cost-effectiveness of recommending Drink Less at reducing alcohol consumption compared with usual digital care. DESIGN: Two-arm individually randomised controlled trial. SETTING: Online trial in the United Kingdom (UK). PARTICIPANTS: Hazardous or harmful drinkers (Alcohol Use Disorders Identification Test [AUDIT] score ≥8) aged 18+ who want to drink less alcohol (n = 5562). Participants will be recruited from July 2020 to May 2022 using multiple strategies with a focus on remote digital methods. INTERVENTION AND COMPARATOR: Participants will be randomised to receive either an email recommending that they use Drink Less (intervention) or view the National Health Service (NHS) webpage on alcohol advice (comparator). MEASUREMENTS: The primary outcome is change in self-reported weekly alcohol consumption, assessed using the extended AUDIT-Consumption, between baseline and 6-month follow-up. Secondary outcomes include change in self-reported weekly alcohol consumption assessed at 1- and 3-month follow-ups, and the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life; and use of health services assessed at 6-month follow-up. Effectiveness will be examined with adjusted regression models, adjusting for baseline alcohol consumption and using an intention-to-treat approach. A mixed-methods process evaluation will assess engagement, acceptability and mechanism of action. Economic evaluations will be conducted using both a short- and longer-term time horizon. COMMENTS: This study will establish the effectiveness and cost-effectiveness of the Drink Less app at reducing alcohol consumption among hazardous and harmful adult drinkers and will be the first randomised controlled trial of an alcohol reduction app for the general population in the United Kingdom. This study will inform the decision on whether it is worth investing resources in large-scale implementation.

Translating a walking intervention for health professional delivery within primary care: A mixed-methods treatment fidelity assessment.

OBJECTIVES: Existing fidelity studies of physical activity interventions are limited in methodological quality and rigour, particularly those delivered by health care providers in clinical settings. The present study aimed to enhance and assess the fidelity of a walking intervention delivered by health care providers within general practice in line with the NIH Behavior Change Consortium treatment fidelity framework. DESIGN: Two practice nurses and six health care assistants delivered a theory-based walking intervention to 63 patients in their own practices. A cross-sectional mixed-methods study assessed fidelity related to treatment delivery and treatment receipt, from the perspectives of health care providers and patients. METHODS: All providers received training and demonstrated delivery competence prior to the trial. Delivery of intervention content was coded from audio-recordings using a standardized checklist. Qualitative interviews with 12 patients were conducted to assess patient perspectives of treatment receipt and analysed using framework analysis. RESULTS: Overall, 78% of intervention components were delivered as per the protocol (range 36-91%), with greater fidelity for components requiring active engagement from patients (e.g., completion of worksheets). The qualitative data highlighted differences in patients' comprehension of specific intervention components. Understanding of, and engagement with, motivational components aimed at improving self-efficacy was poorer than for volitional planning components. CONCLUSIONS: High levels of fidelity of delivery were demonstrated. However, patient-, provider-, and component-level factors impacted on treatment delivery and receipt. We recommend that methods for the enhancement and assessment of treatment fidelity are consistently implemented to enhance the rigour of physical activity intervention research. Statement of contribution What is already known on this subject? Physical activity interventions delivered within primary care by health professionals have so far demonstrated limited impact on behaviour change initiation and maintenance. Treatment fidelity enhancement and assessment strategies can support the successful translation of behaviour change interventions into real-life settings. Few studies have examined treatment fidelity within the context of physical activity interventions, particularly within clinical settings, and existing fidelity studies are limited by methodological quality and rigour. What does this study add? High levels of fidelity were found for a physical activity intervention delivered in primary care. Patient-, provider-, and component-level factors may impact on treatment delivery and receipt. The implementation of best practice fidelity recommendations can support near-optimal fidelity.

Comparison of Trends in Self-reported Cigarette Consumption and Sales in England, 2011 to 2018.

Importance: Population cigarette consumption is declining in many countries. Accurate estimates of long- and short-term changes are vital for policy evaluation and planning. Survey data and sales data that are used to make these estimates each have important potential biases, so triangulation using different methods is required for robust estimation. Objectives: To compare monthly estimates of cigarette consumption in England from a nationally representative survey and recorded cigarette sales and to triangulate an accurate estimate of changes in cigarette consumption since 2011. Design, Setting, and Participants: This study used time series analyses based on survey data and recorded cigarette sales to estimate and compare trends in population cigarette consumption in England from 2011 to 2018. Survey participants were representative samples of 1700 people aged 16 years or older each month in England. Main Outcomes and Measures: Monthly cigarette retail sales data from August 2011 through February 2018 were obtained from a data agency. Monthly self-reports of cigarette consumption were collected over the same period using the Smoking Toolkit Study. Results: A total of 136 677 individuals (51.1% female; mean [SD] age, 46.7 [18.8] years) were surveyed. Over the study period, mean monthly cigarette consumption in England was 2.85 billion (95% CI, 2.78 billion to 2.93 billion) cigarettes based on survey data compared with 3.08 billion (95% CI, 3.03 billion to 3.13 billion) estimated from sales data. Over the whole period, cigarette consumption declined by 24.4% based on survey data and 24.1% based on sales data. This equated to 118.4 million and 117.4 million fewer cigarettes consumed per month (or approximately 1.4 billion per year) based on survey data and sales data, respectively. After adjusting for underlying trends, month-by-month changes in cigarette consumption were closely aligned: a 1% change in survey-estimated cigarette consumption was associated with a 0.98% (95% CI, 0.53%-1.44%) change in sales estimates. Conclusions and Relevance: Survey data and sales data were closely aligned in showing that overall cigarette sales in England have declined by almost a quarter since 2011, amounting to more than 1 billion fewer cigarettes smoked each year. The alignment between the 2 methods provides increased confidence in the accuracy of parameters provided by the Smoking Toolkit Study and sales data. It indicates that estimated changes in cigarette consumption are robust and provide a meaningful basis for policy evaluation and planning.

Socioeconomic inequalities in the delivery of brief interventions for smoking and excessive drinking: findings from a cross-sectional household survey in England.

OBJECTIVES: Brief interventions (BI) for smoking and risky drinking are effective and cost-effective policy approaches to reducing alcohol harm currently used in primary care in England; however, little is known about their contribution to health inequalities. This paper aims to investigate whether self-reported receipt of BI is associated with socioeconomic position (SEP) and whether this differs for smoking or alcohol. DESIGN: Population survey of 8978 smokers or risky drinkers in England aged 16+ taking part in the Alcohol and Smoking Toolkit Studies. MEASURES: Survey participants answered questions regarding whether they had received advice and support to cut down their drinking or smoking from a primary healthcare professional in the past 12 months as well as their SEP, demographic details, whether they smoke and their motivation to cut down their smoking and/or drinking. Respondents also completed the Alcohol Use Disorders Identification Test (AUDIT). Smokers were defined as those reporting any smoking in the past year. Risky drinkers were defined as those scoring eight or more on the AUDIT. RESULTS: After adjusting for demographic factors and patterns in smoking and drinking, BI delivery was highest in lower socioeconomic groups. Smokers in the lowest social grade had 30% (95% CI 5% to 61%) greater odds of reporting receipt of a BI than those in the highest grade. The relationship for risky drinking appeared stronger, with those in the lowest social grade having 111% (95% CI 27% to 252%) greater odds of reporting BI receipt than the highest grade. Rates of BI delivery were eight times greater among smokers than risky drinkers (48.3% vs 6.1%). CONCLUSIONS: Current delivery of BI for smoking and drinking in primary care in England may be contributing to a reduction in socioeconomic inequalities in health. This effect could be increased if intervention rates, particularly for drinking, were raised.

Correction: Associations between socio-economic factors and alcohol consumption: A population survey of adults in England.

[This corrects the article DOI: 10.1371/journal.pone.0209442.].

What do cost-effective health behaviour-change interventions contain? A comparison of six domains.

OBJECTIVES: To help implement behaviour change interventions (BCIs) in practice it is important to be able to characterize their key components. This study compared broad features of cost-effective BCIs that addressed smoking, diet, physical activity, alcohol and sexual health. It also assessed the association of these with the magnitude of the cost-effectiveness estimates. METHODS: A content analysis of 79 interventions based on 338 intervention descriptions was conducted, using the Behaviour Change Wheel (BCW) to classify intervention content in terms of intervention functions, and the BCT taxonomy to identify and categorise component Behaviour Change Techniques (BCT). Regression analysis identified the association of these with upper (pessimistic) and lower (optimistic) cost-effectiveness estimates. RESULTS: The most and least common functions and BCT clusters were education (82.3%) and shaping knowledge (79.7%), and coercion (3.8%) and covert learning (2.5%). Smoking interventions contained the largest ([Formula: see text] = 12) number of BCTs and were most cost-effective. Several other factors were associated with worse (coercionfunction ßupper = 36551.24; shaping knowledgeBCT ßlower = 2427.78; comparison of outcomesBCT ßupper = 9067.32; repetition and substitutionBCT ßupper = 7172.47) and better (modellingfunction ßlower = -2905.3; environmental restructuringfunction ßupper = -8646.28; reward and threatBCT ßupper = -5577.59) cost-effectiveness (p<0.05). DISCUSSION: Cost-effective BCIs rely heavily on education with smoking interventions exhibiting the most comprehensive range of BCTs. Providing an example to aspire to, restructuring the environment and rewarding positive behaviour may be associated with greater cost-effectiveness.

Associations between socio-economic factors and alcohol consumption: A population survey of adults in England.

AIM: To gain a better understanding of the complex relationships of different measures of social position, educational level and income with alcohol consumption in England. METHOD: Between March 2014 and April 2018 data were collected on n = 57,807 alcohol drinkers in England taking part in the Alcohol Toolkit Study (ATS). Respondents completed the AUDIT-C measure of frequency of alcohol consumption, amount consumed on a typical day and binge drinking frequency. The first two questions were used to derive a secondary measure of quantity: average weekly unit consumption. Socio-economic factors measured were: social-grade (based on occupation), employment status, educational qualifications, home and car ownership and income. Models were constructed using ridge regression to assess the contribution of each predictor taking account of high collinearity. Models were adjusted for age, gender and ethnicity. RESULTS: The strongest predictor of frequency of alcohol consumption was social-grade. Those in the two lowest occupational categories of social grade (e.g. semi-skilled and unskilled manual workers, and unemployed, pensioners, casual workers) has fewer drinking occasions than those in professional-managerial occupations (ß = -0.29, 95%CI -0.34 to -0.25; ß = -0.31, 95%CI -0.33 to -0.29). The strongest predictor of consumed volume and binge drinking frequency was lower educational attainment: those whose highest qualification was an A-level (i.e. college/high school qualification) drank substantially more on a typical day (ß = 0.28, 95%CI 0.25 to 0.31) and had a higher weekly unit intake (ß = 3.55, 95%CI 3.04 to 4.05) than those with a university qualification. They also reported a higher frequency of binge drinking (ß = 0.11, 95%CI 0.09 to 0.14). Housing tenure was a strong predictor of all drinking outcomes, while employment status and car ownership were the weakest predictors of most outcomes. CONCLUSION: Social-grade and educational attainment appear to be the strongest socioeconomic predictors of alcohol consumption indices in England, followed closely by housing tenure. Employment status and car ownership have the lowest predictive power.

Developing an implementation strategy for a digital health intervention: an example in routine healthcare.

BACKGROUND: Evidence on how to implement new interventions into complex healthcare environments is often poorly reported and indexed, reducing its potential to inform initiatives to improve healthcare services. Using the implementation of a digital intervention within routine National Health Service (NHS) practice, we provide an example of how to develop a theoretically based implementation plan and how to report it transparently. In doing so we also highlight some of the challenges to implementation in routine healthcare. METHODS: The implemented intervention was HeLP-Diabetes, a digital self-management programme for people with Type 2 Diabetes, which was effective in improving diabetes control. The target setting for the implementation was an inner city London Clinical Commissioning Group in the NHS comprised of 34 general practices. HeLP-Diabetes was designed to be offered to patients as part of routine diabetes care across England. Evidence synthesis, engagement of local stakeholders, a theory of implementation (Normalization Process Theory), feedback, qualitative interviews and usage data were used to develop an implementation plan. RESULTS: A new implementation plan was developed to implement HeLP-Diabetes within routine practice. Individual component strategies were selected and developed informed by Normalization Process Theory. These strategies included: engagement of local opinion leaders, provision of educational materials, educational visits, educational meetings, audit and feedback and reminders. Additional strategies were introduced iteratively to address barriers that arose during the implementation. Barriers largely related to difficulties in allocating resources to implement the intervention within routine care. CONCLUSION: This paper provides a worked example of implementing a digital health intervention. The learning from this work can inform others undertaking the work of planning and executing implementation activities in routine healthcare. Of particular importance is: the selection of appropriate theory to guide the implementation process and selection of strategies; ensuring that enough attention is paid to planning implementation; and a flexible approach that allows response to emerging barriers.

Effectiveness-implementation of COPD case finding and self-management action plans in low- and middle-income countries: global excellence in COPD outcomes (GECo) study protocol.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is the end result of a susceptible individual being exposed to sufficiently deleterious environmental stimuli. More than 90% of COPD-related deaths occur in low- and middle-income countries (LMICs). LMICs face unique challenges in managing COPD; for example, deficient primary care systems present challenges for proper diagnosis and management. Formal diagnosis of COPD requires quality-assured spirometry, which is often limited to urban health centres. Similarly, standard treatment options for COPD remain limited where few providers are trained to manage COPD. The Global Excellence in COPD Outcomes (GECo) studies aim to assess the performance of a COPD case-finding questionnaire with and without peak expiratory flow (PEF) to diagnose COPD, and inform the effectiveness and implementation of COPD self-management Action Plans in LMIC settings. The ultimate goal is to develop simple, low-cost models of care that can be implemented in LMICs. This study will be carried out in Nepal, Peru and Uganda, three distinct LMIC settings. METHODS/DESIGN: We aim to assess the diagnostic accuracy of a simple questionnaire with and without PEF to case-find COPD (GECo1), and examine the effectiveness, cost-effectiveness and implementation of a community-health-worker-supported self-management Action Plan strategy for managing exacerbations of COPD (GECo2). To achieve the first aim, we will enrol a randomly selected sample of up to 10,500 adults aged ≥ 40 years across our three sites, with the goal to enrol 240 participants with moderate-to-severe COPD in to GECo2. We will apply two case-finding questionnaires (Lung Function Questionnaire and CAPTURE) with and without PEF and compare performance against spirometry. We will report ROC areas, sensitivity and specificity. Individuals who are identified as having COPD grades B-D will be invited to enrol in an effectiveness-implementation hybrid randomised trial of a multi-faceted COPD self-management Action Plan intervention delivered by CHWs. The intervention group will receive (1) COPD education, (2) facilitated-self management Action Plans for COPD exacerbations and (3) monthly visits by community health workers. The control group will receive COPD education and standard of care treatment provided by local health providers. Beginning at baseline, we will measure quality of life with the EuroQol-5D (EQ-5D) and St. George's Respiratory Questionnaire (SGRQ) every 3 months over a period of 1 year. The primary endpoint is SGRQ at 12 months. Quality-adjusted life years (QALYs) using the Short-Form 36 version 2 will also be calculated. We will additionally assess the acceptability and feasibility of implementing COPD Action Plans in each setting among providers and individuals with COPD. DISCUSSION: This study should provide evidence to inform the use of pragmatic models of COPD diagnosis and management in LMIC settings. TRIAL REGISTRATION: NCT03359915 (GECo1). Registered on 2 December 2017 and NCT03365713 (GECo2). Registered on 7 December 2017. Trial acronym: Global Excellence in COPD Outcomes (GECo1; GECo2).

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

INTRODUCTION: The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention. METHODS AND ANALYSIS: The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders' mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. ETHICS AND DISSEMINATION: This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015-283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations. TRIAL REGISTRATION NUMBER: ISRCTN11707331; Pre-results.

Clinical and cost-effectiveness of an intervention for reducing cholesterol and cardiovascular risk for people with severe mental illness in English primary care: a cluster randomised controlled trial.

BACKGROUND: People with severe mental illnesses, including psychosis, have an increased risk of cardiovascular disease. We aimed to evaluate the effects of a primary care intervention on decreasing total cholesterol concentrations and cardiovascular disease risk in people with severe mental illnesses. METHODS: We did this cluster randomised trial in general practices across England, with general practices as the cluster unit. We randomly assigned general practices (1:1) with 40 or more patients with severe mental illnesses using a computer-generated random sequence with a block size of four. Researchers were masked to allocation, but patients and general practice staff were not. We included participants aged 30-75 years with severe mental illnesses (schizophrenia, bipolar disorder, or psychosis), who had raised cholesterol concentrations (5·0 mmol/L) or a total:HDL cholesterol ratio of 4·0 mmol/L or more and one or more modifiable cardiovascular disease risk factors. Eligible participants were recruited within each practice before randomisation. The Primrose intervention consisted of appointments (≤12) with a trained primary care professional involving manualised interventions for cardiovascular disease prevention (ie, adhering to statins, improving diet or physical activity levels, reducing alcohol, or quitting smoking). Treatment as usual involved feedback of screening results only. The primary outcome was total cholesterol at 12 months and the primary economic analysis outcome was health-care costs. We used intention-to-treat analysis. The trial is registered with Current Controlled Trials, number ISRCTN13762819. FINDINGS: Between Dec 10, 2013, and Sept 30, 2015, we recruited general practices and between May 9, 2014, and Feb 10, 2016, we recruited participants and randomly assigned 76 general practices with 327 participants to the Primrose intervention (n=38 with 155 patients) or treatment as usual (n=38 with 172 patients). Total cholesterol concentration data were available at 12 months for 137 (88%) participants in the Primrose intervention group and 152 (88%) participants in the treatment-as-usual group. The mean total cholesterol concentration did not differ at 12 months between the two groups (5·4 mmol/L [SD 1·1] for Primrose vs 5·5 mmol/L [1·1] for treatment as usual; mean difference estimate 0·03, 95% CI -0·22 to 0·29; p=0·788). This result was unchanged by pre-agreed supportive analyses. Mean cholesterol decreased over 12 months (-0·22 mmol/L [1·1] for Primrose vs -0·36 mmol/L [1·1] for treatment as usual). Total health-care costs (£1286 [SE 178] in the Primrose intervention group vs £2182 [328] in the treatment-as-usual group; mean difference -£895, 95% CI -1631 to -160; p=0·012) and psychiatric inpatient costs (£157 [135] vs £956 [313]; -£799, -1480 to -117; p=0·018) were lower in the Primrose intervention group than the treatment-as-usual group. Six serious adverse events of hospital admission and one death occurred in the Primrose group (n=7) and 23, including three deaths, occurred in the treatment-as-usual group (n=18). INTERPRETATION: Total cholesterol concentration at 12 months did not differ between the Primrose and treatment-as-usual groups, possibly because of the cluster design, good care in the treatment-as-usual group, short duration of the intervention, or suboptimal focus on statin prescribing. The association between the Primrose intervention and fewer psychiatric admissions, with potential cost-effectiveness, might be important. FUNDING: National Institute of Health Research Programme Grants for Applied Research.

Personalised digital interventions for reducing hazardous and harmful alcohol consumption in community-dwelling populations.

BACKGROUND: Excessive alcohol use contributes significantly to physical and psychological illness, injury and death, and a wide array of social harm in all age groups. A proven strategy for reducing excessive alcohol consumption levels is to offer a brief conversation-based intervention in primary care settings, but more recent technological innovations have enabled people to interact directly via computer, mobile device or smartphone with digital interventions designed to address problem alcohol consumption. OBJECTIVES: To assess the effectiveness and cost-effectiveness of digital interventions for reducing hazardous and harmful alcohol consumption, alcohol-related problems, or both, in people living in the community, specifically: (i) Are digital interventions more effective and cost-effective than no intervention (or minimal input) controls? (ii) Are digital interventions at least equally effective as face-to-face brief alcohol interventions? (iii) What are the effective component behaviour change techniques (BCTs) of such interventions and their mechanisms of action? (iv) What theories or models have been used in the development and/or evaluation of the intervention? Secondary objectives were (i) to assess whether outcomes differ between trials where the digital intervention targets participants attending health, social care, education or other community-based settings and those where it is offered remotely via the internet or mobile phone platforms; (ii) to specify interventions according to their mode of delivery (e.g. functionality features) and assess the impact of mode of delivery on outcomes. SEARCH METHODS: We searched CENTRAL, MEDLINE, PsycINFO, CINAHL, ERIC, HTA and Web of Knowledge databases; ClinicalTrials.com and WHO ICTRP trials registers and relevant websites to April 2017. We also checked the reference lists of included trials and relevant systematic reviews. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that evaluated the effectiveness of digital interventions compared with no intervention or with face-to-face interventions for reducing hazardous or harmful alcohol consumption in people living in the community and reported a measure of alcohol consumption. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by The Cochrane Collaboration. MAIN RESULTS: We included 57 studies which randomised a total of 34,390 participants. The main sources of bias were from attrition and participant blinding (36% and 21% of studies respectively, high risk of bias). Forty one studies (42 comparisons, 19,241 participants) provided data for the primary meta-analysis, which demonstrated that participants using a digital intervention drank approximately 23 g alcohol weekly (95% CI 15 to 30) (about 3 UK units) less than participants who received no or minimal interventions at end of follow up (moderate-quality evidence).Fifteen studies (16 comparisons, 10,862 participants) demonstrated that participants who engaged with digital interventions had less than one drinking day per month fewer than no intervention controls (moderate-quality evidence), 15 studies (3587 participants) showed about one binge drinking session less per month in the intervention group compared to no intervention controls (moderate-quality evidence), and in 15 studies (9791 participants) intervention participants drank one unit per occasion less than no intervention control participants (moderate-quality evidence).Only five small studies (390 participants) compared digital and face-to-face interventions. There was no difference in alcohol consumption at end of follow up (MD 0.52 g/week, 95% CI -24.59 to 25.63; low-quality evidence). Thus, digital alcohol interventions produced broadly similar outcomes in these studies. No studies reported whether any adverse effects resulted from the interventions.A median of nine BCTs were used in experimental arms (range = 1 to 22). 'B' is an estimate of effect (MD in quantity of drinking, expressed in g/week) per unit increase in the BCT, and is a way to report whether individual BCTs are linked to the effect of the intervention. The BCTs of goal setting (B -43.94, 95% CI -78.59 to -9.30), problem solving (B -48.03, 95% CI -77.79 to -18.27), information about antecedents (B -74.20, 95% CI -117.72 to -30.68), behaviour substitution (B -123.71, 95% CI -184.63 to -62.80) and credible source (B -39.89, 95% CI -72.66 to -7.11) were significantly associated with reduced alcohol consumption in unadjusted models. In a multivariable model that included BCTs with B > 23 in the unadjusted model, the BCTs of behaviour substitution (B -95.12, 95% CI -162.90 to -27.34), problem solving (B -45.92, 95% CI -90.97 to -0.87), and credible source (B -32.09, 95% CI -60.64 to -3.55) were associated with reduced alcohol consumption.The most frequently mentioned theories or models in the included studies were Motivational Interviewing Theory (7/20), Transtheoretical Model (6/20) and Social Norms Theory (6/20). Over half of the interventions (n = 21, 51%) made no mention of theory. Only two studies used theory to select participants or tailor the intervention. There was no evidence of an association between reporting theory use and intervention effectiveness. AUTHORS' CONCLUSIONS: There is moderate-quality evidence that digital interventions may lower alcohol consumption, with an average reduction of up to three (UK) standard drinks per week compared to control participants. Substantial heterogeneity and risk of performance and publication bias may mean the reduction was lower. Low-quality evidence from fewer studies suggested there may be little or no difference in impact on alcohol consumption between digital and face-to-face interventions.The BCTs of behaviour substitution, problem solving and credible source were associated with the effectiveness of digital interventions to reduce alcohol consumption and warrant further investigation in an experimental context.Reporting of theory use was very limited and often unclear when present. Over half of the interventions made no reference to any theories. Limited reporting of theory use was unrelated to heterogeneity in intervention effectiveness.