Uptake of self-management education programmes for people with type 2 diabetes in primary care through the embedding package: a cluster randomised control trial and ethnographic study.

BACKGROUND: Self-management education programmes are cost-effective in helping people with type 2 diabetes manage their diabetes, but referral and attendance rates are low. This study reports on the effectiveness of the Embedding Package, a programme designed to increase type 2 diabetes self-management programme attendance in primary care. METHODS: Using a cluster randomised design, 66 practices were randomised to: (1) a wait-list group that provided usual care for nine months before receiving the Embedding Package for nine months, or (2) an immediate group that received the Embedding Package for 18 months. 'Embedders' supported practices and self-management programme providers to embed programme referral into routine practice, and an online 'toolkit' contained embedding support resources. Patient-level HbA1c (primary outcome), programme referral and attendance data, and clinical data from 92,977 patients with type 2 diabetes were collected at baseline (months - 3-0), step one (months 1-9), step 2 (months 10-18), and 12 months post-intervention. An integrated ethnographic study including observations, interviews, and document analysis was conducted using interpretive thematic analysis and Normalisation Process Theory. RESULTS: No significant difference was found in HbA1c between intervention and control conditions (adjusted mean difference [95% confidence interval]: -0.10 [-0.38, 0.18] mmol/mol; -0.01 [-0.03, 0.02] %). Statistically but not clinically significantly lower levels of HbA1c were found in people of ethnic minority groups compared with non-ethnic minority groups during the intervention condition (-0.64 [-1.08, -0.20] mmol/mol; -0.06% [-0.10, -0.02], p = 0.004), but not greater self-management programme attendance. Twelve months post-intervention data showed statistically but not clinically significantly lower HbA1c (-0.56 [95% confidence interval: -0.71, -0.42] mmol/mol; -0.05 [-0.06, -0.04] %; p < 0.001), and higher self-management programme attendance (adjusted odds ratio: 1.13; 95% confidence interval: 1.02, 1.25; p = 0.017) during intervention conditions. Themes identified through the ethnographic study included challenges for Embedders in making and sustaining contact with practices and providers, and around practices' interactions with the toolkit. CONCLUSIONS: Barriers to implementing the Embedding Package may have compromised its effectiveness. Statistically but not clinically significantly improved HbA1c among ethnic minority groups and in longer-term follow-up suggest that future research exploring methods of embedding diabetes self-management programmes into routine care is warranted. TRIAL REGISTRATION: ISRCTN23474120, registered 05/04/2018.

Promoting and Maintaining Changes in Smoking Behavior for Patients Following Discharge from a Smoke-free Mental Health Inpatient Stay: Development of a Complex Intervention Using the Behavior Change Wheel.

INTRODUCTION: Evidence suggests that smokers can successfully quit, remain abstinent or reduce smoking during a smoke-free mental health inpatient stay, provided behavioral/pharmacological support are offered. However, few evidence-based strategies to prevent the return to prehospital smoking behaviors post-discharge exist. AIMS AND METHODS: We report the development of an intervention designed to support smoking-related behavior change following discharge from a smoke-free mental health stay. We followed the Behavior Change Wheel (BCW) intervention development process. The target behavior was supporting patients to change their smoking behaviors following discharge from a smoke-free mental health stay. Using systematic reviews, we identified the barriers and enablers, classified according to the Theoretical Domains Framework (TDF). Potential intervention functions to address key influences were identified by consulting the BCW and Behavior Change Technique (BCT) taxonomy. Another systematic review identified effectiveness of BCTs in this context. Stakeholder consultations were conducted to prioritize and refine intervention content. RESULTS: Barriers and enablers to supporting smoking cessation were identified within the domains of environmental context and resources (lack of staff time); knowledge (ill-informed interactions about smoking); social influences, and intentions (lack of intention to deliver support). Potential strategies to address these influences included goal setting, problem-solving, feedback, social support, and information on health consequences. A strategy for operationalizing these techniques into intervention components was agreed upon: Pre-discharge evaluation sessions, a personalized resource folder, tailored behavioral and text message support post-discharge, and a peer interaction group, delivered by a trained mental health worker. CONCLUSIONS: The intervention includes targeted resources to support smoking-related behavior change in patients following discharge from a smoke-free mental health setting. IMPLICATIONS: Using the BCW and TDF supported a theoretically and empirically informed process to define and develop a tailored intervention that acknowledges barriers and enablers to supporting smoking cessation in mental health settings. The result is a novel complex theory- and evidence-based intervention that will be formally tested in a randomized controlled feasibility study.

Using Normalisation Process Theory (NPT) to develop an intervention to improve referral and uptake rates for self-management education for patients with type 2 diabetes in UK primary care.

BACKGROUND: Referral and uptake rates of structured self-management education (SSME) for Type 2 diabetes (T2DM) in the UK are variable and relatively low. Research has documented contributing factors at patient, practitioner and organisational levels. We report a project to develop an intervention to improve referral to and uptake of SSME, involving an integrative synthesis of existing datasets and stakeholder consultation and using Normalisation Process Theory (NPT) as a flexible framework to inform the development process. METHODS: A three-phase mixed-methods development process involved: (1) synthesis of existing evidence; (2) stakeholder consultation; and (3) intervention design. The first phase included a secondary analysis of data from existing studies of T2DM SSME programmes and a systematic review of the literature on application of NPT in primary care. Influences on referral and uptake of diabetes SSME were identified, along with insights into implementation processes, using NPT constructs to inform analysis. This gave rise to desirable attributes for an intervention to improve uptake of SSME. The second phase involved engaging with stakeholders to prioritise and then rank these attributes, and develop a list of associated resources needed for delivery. The third phase addressed intervention design. It involved translating the ranked attributes into essential components of a complex intervention, and then further refinement of components and associated resources. RESULTS: In phase 1, synthesised analysis of 64 transcripts and 23 articles generated a longlist of 46 attributes of an embedded SSME, mapped into four overarching domains: valued, integrated, permeable and effectively delivered. Stakeholder engagement in phase 2 progressed this to a priority ranked list of 11. In phase 3, four essential components attending to the prioritised attributes and forming the basis of the intervention were identified: 1) a clear marketing strategy for SSME; 2) a user friendly and effective referral pathway; 3) new/amended professional roles; and 4) a toolkit of resources. CONCLUSIONS: NPT provides a flexible framework for synthesising evidence for the purpose of developing a complex intervention designed to increase and reduce variation in uptake to SSME programmes in primary care settings.

A Systematic Review of Mental Health Professionals, Patients, and Carers' Perceived Barriers and Enablers to Supporting Smoking Cessation in Mental Health Settings.

INTRODUCTION: Evidence-based smoking cessation and temporary abstinence interventions to address smoking in mental health settings are available, but the impact of these interventions is limited. AIMS AND METHODS: We aimed to identify and synthesize the perceived barriers and enablers to supporting smoking cessation in mental health settings. Six databases were searched for articles reporting the investigation of perceived barriers and enablers to supporting smoking cessation in mental health settings. Data were extracted and coded using a mixed inductive/deductive method to the theoretical domains framework, key barriers and enablers were identified through the combining of coding frequency, elaboration, and expressed importance. RESULTS: Of 31 included articles, 56 barriers/enablers were reported from the perspectives of mental healthcare professionals (MHPs), 48 from patient perspectives, 21 from mixed perspectives, and 0 from relatives/carers. Barriers to supporting smoking cessation or temporary abstinence in mental health settings mainly fell within the domains: environmental context and resources (eg, MHPs lack of time); knowledge (eg, interactions around smoking that did occur were ill informed); social influences (eg, smoking norms within social network); and intentions (eg, MHPs lack positive intentions to deliver support). Enablers mainly fell within the domains: environmental context and resources (eg, use of appropriate support materials) and social influences (eg, pro-quitting social norms). CONCLUSIONS: The importance of overcoming competing demands on staff time and resources, the inclusion of tailored, personalized support, the exploitation of patients wider social support networks, and enhancing knowledge and awareness around the benefits smoking cessation is highlighted. IMPLICATIONS: Identified barriers and enablers represent targets for future interventions to improve the support of smoking cessation in mental health settings. Future research needs to examine the perceptions of the carers and family/friends of patients in relation to the smoking behavior change support delivered to patients.

Supporting smoking cessation and preventing relapse following a stay in a smoke-free setting: a meta-analysis and investigation of effective behaviour change techniques.

BACKGROUND AND AIMS: Admission to a smoke-free setting presents a unique opportunity to encourage smokers to quit. However, risk of relapse post-discharge is high, and little is known about effective strategies to support smoking cessation following discharge. We aimed to identify interventions that maintain abstinence following a smoke-free stay and determine their effectiveness, as well as the probable effectiveness of behaviour change techniques (BCTs) used in these interventions. METHODS: Systematic review and meta-analyses of studies of adult smokers aged ≥ 18 years who were temporarily or fully abstinent from smoking to comply with institutional smoke-free policies. Institutions included prison, inpatient mental health, substance misuse or acute hospital settings. A Mantel-Haenszel random-effects meta-analysis of randomized controlled trials (RCTs) was conducted using biochemically verified abstinence (7-day point prevalence or continuous abstinence). BCTs were defined as 'promising' in terms of probable effectiveness (if BCT was present in two or more long-term effective interventions) and feasibility (if BCT was also delivered in ≥ 25% of all interventions). RESULTS: Thirty-seven studies (intervention n = 9041, control n = 6195) were included: 23 RCTs (intervention n = 6593, control n = 5801); three non-randomized trials (intervention n = 845, control n = 394) and 11 cohort studies (n = 1603). Meta-analysis of biochemically verified abstinence at longest follow-up (4 weeks-18 months) found an overall effect in favour of intervention [risk ratio (RR) = 1.27, 95% confidence interval (CI) = 1.08-1.49, I2  = 42%]. Nine BCTs (including 'pharmacological support', 'goal-setting (behaviour)' and 'social support') were characterized as 'promising' in terms of probable effectiveness and feasibility. CONCLUSIONS: A systematic review and meta-analyses indicate that behavioural and pharmacological support is effective in maintaining smoking abstinence following a stay in a smoke-free institution. Several behaviour change techniques may help to maintain smoking abstinence up to 18 months post-discharge.

Increasing uptake of structured self-management education programmes for type 2 diabetes in a primary care setting: a feasibility study.

BACKGROUND: Structured self-management education (SSME) for people with type 2 diabetes mellitus (T2DM) improves biomedical and psychological outcomes, whilst being cost-effective. Yet uptake in the UK remains low. An 'Embedding Package' addressing barriers and enablers to uptake at patient, health care professional and organisational levels has been developed. The aim of this study was to test the feasibility of conducting a subsequent randomised controlled trial (RCT) to evaluate the Embedding Package in primary care, using a mixed methods approach. METHODS: A concurrent mixed methods approach was adopted. Six general practices in the UK were recruited and received the intervention (the Embedding Package). Pseudonymised demographic, biomedical and SSME data were extracted from primary care medical records for patients recorded as having a diagnosis of T2DM. Descriptive statistics assessed quantitative data completeness and accuracy. Quantitative data were supplemented and validated by a patient questionnaire, for which two recruitment methods were trialled. Where consent was given, the questionnaire and primary care data were linked and compared. The cost of the intervention was estimated. An integrated qualitative study comprising ethnography and stakeholder and patient interviews explored the process of implementation, sustainability of change and 'fit' of the intervention. Qualitative data were analysed using a thematic framework guided by the Normalisation Process Theory (NPT). RESULTS: Primary care data were extracted for 2877 patients. The primary outcome for the RCT, HbA1c, was over 90% complete. Questionnaires were received from 423 (14.7%) participants, with postal invitations yielding more participants than general practitioner (GP) prompts. Ninety-one percent of questionnaire participants consented to data linkage. The mean cost per patient for the Embedding Package was £8.94, over a median follow-up of 162.5 days. Removing the development cost, this reduces to £5.47 per patient. Adoption of ethnographic and interview methods in the collection of data was appropriate, and the use of NPT, whilst challenging, enhanced the understanding of the implementation process. The need to delay the collection of patient interview data to enable the intervention to inform patient care was highlighted. CONCLUSIONS: It is feasible to collect data with reasonable completeness and accuracy for the subsequent RCT, although refinement to improve the quality of the data collected will be undertaken. Based on resource use data collected, it was feasible to produce cost estimates for each individual component of the Embedding Package. The methods chosen to generate, collect and analyse qualitative data were satisfactory, keeping participant burden low and providing insight into potential refinements of the Embedding Package and customisation of the methods for the RCT. TRIAL REGISTRATION: ISRCTN, ISRCTN21321635, Registered 07/07/2017-retrospectively registered.

Application of normalisation process theory in understanding implementation processes in primary care settings in the UK: a systematic review.

BACKGROUND: Normalisation Process Theory (NPT) provides a framework to understand how interventions are implemented, embedded, and integrated in healthcare settings. Previous reviews of published literature have examined the application of NPT across international healthcare and reports its benefits. However, given the distinctive clinical function, organisational arrangements and the increasing management of people with a wide variety of conditions in primary care settings in the United Kingdom, it is important to understand how and why authors utilise and reflect on NPT in such settings to inform and evaluate implementation processes. METHODS: A systematic review of peer-reviewed literature using NPT in primary care settings in the United Kingdom (UK) was conducted. Eight electronic databases were searched using replicable methods to identify articles published between January 2012 and April 2018. Data were analysed using a framework approach. RESULTS: Thirty-one articles met the inclusion criteria. Researchers utilised NPT to explore the implementation of interventions, targeting a wide range of health services and conditions, within primary care settings in the UK. NPT was mostly applied qualitatively; however, a small number of researchers have moved towards mixed and quantitative methods. Some variation was observed in the use of NPT constructs and sub-constructs, and whether and how researchers undertook modification to make them more relevant to the implementation process and multiple stakeholder perspectives. CONCLUSION: NPT provides a flexible framework for the development and evaluation of complex healthcare interventions in UK primary care settings. This review updates the literature on NPT use and indicates that its application is well suited to these environments, particularly in supporting patients with long-term conditions and co-morbidities. We recommend future research explores the receipt of interventions by multiple stakeholders and suggest that authors reflect on justifications for using NPT in their reporting.

The impact of an intervention to increase uptake to structured self-management education for people with type 2 diabetes mellitus in primary care (the embedding package), compared to usual care, on glycaemic control: study protocol for a mixed methods study incorporating a wait-list cluster randomised controlled trial.

BACKGROUND: Approximately 425 million people globally have diabetes, with ~ 90% of these having Type 2 Diabetes Mellitus (T2DM). This is a condition that leads to a poor quality of life and increased risk of serious health complications. Structured self-management education (SSME) has been shown to be effective in improving glycaemic control and patient related outcome measures and to be cost-effective. However, despite the demonstrated benefits, attendance at SSME remains low. An intervention has been developed to embed SSME called the 'Embedding Package'. The intervention aims to address barriers and enhance enablers to uptake of SSME at patient, healthcare professional and organisational levels. It comprises a marketing strategy, user friendly and effective referral pathways, new roles to champion SSME and a toolkit of resources. METHODS: A mixed methods study incorporating a wait-list cluster randomised trial and ethnographic study, including 66 UK general practices, will be conducted with two intervention start times (at 0 and 9 months), each followed by an active delivery phase. At 18 months, the intervention will cease to be actively delivered and a 12 month observational follow-up phase will begin. The intervention, the Embedding Package, aims to increase SSME uptake and subsequent improvements in health outcomes, through a clear marketing strategy, user friendly and effective referral pathways, a local clinical champion and an 'Embedder' and a toolkit of resources for patients, healthcare professionals and other key stakeholders. The primary aim is, through increasing uptake to and attendance at SSME, to reduce HbA1c in people with T2DM compared with usual care. Secondary objectives include: assessing whether there is an increase in referral to and uptake of SSME and improvements in biomedical and psychosocial outcomes; an assessment of the sustainability of the Embedding Package; contextualising the process of implementation, sustainability of change and the 'fit' of the Embedding Package; and an assessment of the cost-effectiveness of the Embedding Package. DISCUSSION: This study will assess the effectiveness, cost-effectiveness and sustainability of the Embedding Package, an intervention which aims to improve biomedical and psychosocial outcomes of people with T2DM, through increased referral to and uptake of SSME. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number ISRCTN23474120. Assigned 05/04/2018. The study was prospectively registered. On submission of this manuscript practice recruitment is complete, participant recruitment is ongoing and expected to be completed by the end of 2019.

Complete smokefree policies in mental health inpatient settings: results from a mixed-methods evaluation before and after implementing national guidance.

BACKGROUND: Tobacco smoking is extremely prevalent in people with severe mental illness (SMI) and has been recognised as the main contributor to widening health inequalities in this population. Historically, smoking has been deeply entrenched in the culture of mental health settings in the UK, and until recently, smokefree policies tended to be only partially implemented. However, recent national guidance and the government's tobacco control plan now call for the implementation of complete smokefree policies. Many mental health Trusts across the UK are currently in the process of implementing the new guidance, but little is known about the impact of and experience with policy implementation. METHODS: This paper reports findings from a mixed-methods evaluation of policy implementation across 12 wards in a large mental health Trust in England. Quantitative data were collected and compared before and after implementation of NICE guidance PH48 and referred to 1) identification and treatment of tobacco dependence, 2) smoking-related incident reporting, and 3) prescribing of psychotropic medication. A qualitative exploration of the experience of inpatients was also carried out. Descriptive statistical analyses were performed, and the feasibility of collecting relevant and complete data for each quantitative component was assessed. Qualitative data were analysed using thematic framework analysis. RESULTS: Following implementation of the complete smokefree policy, increases in the numbers of patients offered smoking cessation advice (72% compared to 38%) were identified. While incident reports demonstrated a decrease in challenging behaviour during the post-PH48 period (6% compared to 23%), incidents relating to the concealment of smoking materials increased (10% compared to 2%). Patients reported encouraging changes in smoking behaviour and motivation to maintain change after discharge. However, implementation issues challenging full policy implementation, including covert facilitation of smoking by staff, were reported, and difficulties in collecting relevant and complete data for comprehensive evaluation purposes identified. CONCLUSIONS: Overall, the implementation of complete smokefree policies in mental health settings may currently be undermined by partial support. Strategies to enhance support and the establishment of suitable data collection pathways to monitor progress are required.

Smoking and Looked-After Children: A Mixed-Methods Study of Policy, Practice, and Perceptions Relating to Tobacco Use in Residential Units.

Despite the implementation of smoke-free policies by local authorities and a statutory requirement to promote the health and well-being of looked-after children and young people in England, rates of tobacco use by this population are substantially higher than in the general youth population. A mixed-methods study, comprising a survey of residential care officers in 15 local authority-operated residential units and semi-structured, face-to-face interviews with residential carers in three local authority-operated residential units, was conducted in the East Midlands. Survey data were descriptively analysed; and interview data were transcribed and analysed using thematic framework analysis. Forty-two care officers (18% response rate) completed the survey, and 14 participated in the interviews. Despite reporting substantial awareness of smoke-free policies, a lack of adherence and enforcement became apparent, and levels of reported training in relation to smoking and smoking cessation were low (21%). Potential problems relating to wider tobacco-related harms, such as exploitative relationships; a reliance on tacit knowledge; and pessimistic attitudes towards LAC quitting smoking, were indicated. The findings highlight the need for the development of comprehensive strategies to promote adherence to and enforcement of local smoke-free policy within residential units for looked-after children and young people, and to ensure appropriate support pathways are in place for this population.

Preparing for Completely Smoke-Free Mental Health Settings: Findings on Patient Smoking, Resources Spent Facilitating Smoking Breaks, and the Role of Smoking in Reported Incidents from a Large Mental Health Trust in England.

INTRODUCTION: Despite high smoking prevalence and excessive smoking-related morbidity and mortality among people with mental disorder compared to the general population, smoking treatment is often neglected in mental health settings. The UK National Institute of Health and Clinical Excellence (NICE) recently issued public health guidance stipulating completely smoke-free mental health settings. This project evaluated existing smoking-related practices in preparation for guidance implementation. The objectives were to: audit the recording of smoking-related information and treatment provision; explore current arrangements relating to the facilitation of patient smoking; measure staff time spent and identify costs of facilitating smoking; and explore the role of smoking in smoking-related incidents. METHODS: A mixed-methods study was conducted across four acute adult mental health wards, accommodating 16 patients each, over six months. It included a case-note audit, on-site observations, and a qualitative content analysis of incident reports. RESULTS: Smoking status was recorded for less than half of the 290 patients admitted (138, 48%). Of those, 98 (71%) were recorded as current smokers, of whom 72 (74%) had received brief smoking cessation advice. Staff spent 6028 h facilitating smoking, representing an annual cost of £ 131,040 across four wards. Incident reports demonstrated that smoking facilitation was often central to the cause of incidences, triggered frustration in patients, and strained staff resources. CONCLUSION: The findings highlight the importance and potential of implementing completely smoke-free policies using comprehensive pathways.

Treating tobacco dependence in older adults: a survey of primary care clinicians' knowledge, attitudes, and practice.

BACKGROUND: The benefits of smoking cessation among older people are well documented. Despite this, evidence suggests that older smokers are rarely engaged in smoking cessation efforts, and that existing tobacco dependence treatments require further tailoring to the specific needs of older smokers. This study assesses the knowledge, attitudes, and clinical practice of primary care clinicians in relation to addressing tobacco dependence among older people. METHODS: A cross-sectional survey of 427 NHS primary care clinicians in a large English city was conducted using modified version of a previously validated questionnaire. RESULTS: One hundred and seventy one clinicians (40 % response rate) completed the survey. While the majority (90.0 %) of respondents reported enquiring regularly about older patients' smoking status, just over half (59.1 %) reported providing older patients with smoking cessation support. A lack of awareness in relation to the prevalence and impact of smoking in later life were apparent: e.g. only 47 % of respondents were aware of that approximately 10 life years are lost due to smoking related disease, and only 59 % knew that smoking can reduce the effectiveness of medication prescribed for conditions common in later life. Self-reported attendance at smoking-related training was significantly associated with proactive clinical practice. CONCLUSIONS: There is a need to improve clinicians' knowledge, in relation to smoking and smoking cessation in older patients and to build clinician confidence in seizing teachable moments.

A cross-sectional survey of mental health clinicians' knowledge, attitudes, and practice relating to tobacco dependence among young people with mental disorders.

BACKGROUND: Mental health services in England are smoke-free by law and expected to provide comprehensive support to patients who smoke. Although clinicians' knowledge in this area is reported to be limited, research exploring the issue in Child and Adolescent Mental Health Services (CAMHS) is lacking. This study aimed to investigate the knowledge, attitudes, and practice of clinicians working within specialist and highly specialist Child and Adolescent Mental Health Services (CAMHS) relating to tobacco dependence, its treatment and its relation to mental disorder. METHODS: A cross-sectional survey of clinicians working across all CAMHS teams of a large UK National Health Service mental health Trust. RESULTS: Sixty clinicians (50% response rate) completed the survey. Less than half (48.3%) believed that addressing smoking was part of their responsibility, and half (50%) asserted confidence in supporting patients in a cessation attempt. Misconceptions relating to smoking were present across all staff groups: e.g. only 40% of respondents were aware of potential interactions between smoking and antipsychotic medications, although psychiatrists were more knowledgeable than non-medical clinicians (91.6% vs 27.1%; OR 3.4, p < .001). Self-reported attendance at smoking-related training was significantly associated with more proactive clinical practice. CONCLUSIONS: There is a need to improve clinicians' knowledge, capacity and confidence in effectively identifying, motivating, supporting and treating young smokers in the context of treatment for mental disorders.