Implementation of the Family Nurse Partnership programme in England: experiences of key health professionals explored through trial parallel process evaluation.

BACKGROUND: The Family Nurse Partnership (FNP) programme was introduced to support young first-time mothers. A randomised trial found FNP added little short-term benefit compared to usual care. The study included a comprehensive parallel process evaluation, including focus groups, conducted to aid understanding of the introduction of the programme into a new service and social context. The aim of the focus groups was to investigate views of key health professionals towards the integration and delivery of FNP programme in England. METHODS: Focus groups were conducted separately with Family Nurses, Health Visitors and Midwives at trial sites during 2011-2012. Transcripts from audio-recordings were analysed thematically. RESULTS: A total of 122 professionals participated in one of 19 focus groups. Family Nurses were confident in the effectiveness of FNP, although they experienced practical difficulties meeting programme fidelity targets and considered that programme goals did not sufficiently reflect client or community priorities. Health Visitors and Midwives regarded FNP as well-resourced and beneficial to clients, describing their own services as undervalued and struggling. They wished to work closely with Family Nurses, but felt excluded from doing so by practical barriers and programme protection. CONCLUSION: FNP was described as well-resourced and delivered by highly motivated and well supported Family Nurses. FNP eligibility, content and outcomes conflicted with individual client and community priorities. These factors may have restricted the potential effectiveness of a programme developed and previously tested in a different social milieu. Building Blocks ISRCTN23019866 Registered 20/04/2009.

Motivational interviewing competencies among UK family nurse partnership nurses: a process evaluation component of the building blocks trial.

BACKGROUND: Motivational Interviewing (MI) is a person-centred counselling approach to behaviour change which is increasingly being used in public health settings, either as a stand-alone approach or in combination with other structured programmes of health promotion. One example of this is the Family Nurse Partnership (FNP) a licensed, preventative programme for first time mothers under the age of 20, delivered by specialist family nurses who are additionally trained in MI. The Building Blocks trial was an individually randomised controlled trial comparing effectiveness of Family Nurse Partnership when added to usual care compared to usual care alone within 18 sites in England. The aim of this process evaluation component of the trial is to determine the extent to which Motivational Interviewing skills taught to Family Nurse Partnership nurses were used in their home visits with clients. METHODS: Between July 2010 and November 2011, 92 audio-recordings of nurse-client consultations were collected during the 'pregnancy' and 'infancy' phases of the FNP programme. They were analysed using The Motivational Interviewing Treatment Integrity (MITI) coding system. RESULTS: A competent level of overall MI adherent practice according to the MITI criteria for 'global clinician ratings' was apparent in over 70 % of the consultations. However, on specific behaviours and the MITI-derived practitioner competency variables, there was a large variation in the percentage of recordings in which "beginner proficiency" levels in MI (as defined by the MITI criteria) was achieved, ranging from 73.9 % for the 'MI adherent behaviour' variable in the pregnancy phase to 6.7 % for 'percentage of questions coded as open' in the infancy phase. CONCLUSIONS: The results suggest that it is possible to deliver a structured programme in an MI-consistent way. However, some of the behaviours regarded as key to MI practice such as the percentage of questions coded as open can be more difficult to achieve in such a context. This is an important consideration for those involved in designing effective structured interventions with an MI-informed approach and wanting to maintain fidelity to both MI and the structured programme. TRIAL REGISTRATION: Current Controlled Trials ISRCTN23019866 Registered 20/4/2009.

Feasibility and impact of a computerised clinical decision support system on investigation and initial management of new onset chest pain: a mixed methods study.

BACKGROUND: Clinical decision support systems (CDSS) can modify clinician behaviour, yet the factors influencing their effect remain poorly understood. This study assesses the feasibility and acceptability of a CDSS supporting diagnostic and treatment decisions for patients with suspected stable angina. METHODS: Intervention The Optimising Management of Angina (OMA) programme includes a CDSS guiding investigation and medication decisions for clinicians managing patients with new onset stable angina, based on English national guidelines, introduced through an educational intervention. Design and participants A mixed methods study i. A study of outcomes among patients presenting with suspected angina in three chest pain clinics in England before and after introduction of the OMA programme. ii. Observations of clinic processes, interviews and a focus group with health professionals at two chest pain clinics after delivery of the OMA programme. OUTCOMES: Medication and cardiovascular imaging investigations undertaken within six months of presentation, and concordance of these with the recommendations of the CDSS. Thematic analysis of qualitative data to understand how the CDSS was used. RESULTS: Data were analysed for 285 patients attending chest pain clinics: 106 before and 179 after delivery of the OMA programme. 40 consultations were observed, 5 clinicians interviewed, and a focus group held after the intervention. The proportion of patients appropriate for diagnostic investigation who received one was 50 % (95 CI 34-66 %) of those before OMA and 59 % (95 CI 48-70 %) of those after OMA. Despite high use of the CDSS (84 % of consultations), observations and interviews revealed difficulty with data entry into the CDSS, and structural and practical barriers to its use. In the majority of cases the CDSS was not used to guide real-time decision making, only being consulted after the patient had left the room. CONCLUSIONS: The OMA CDSS for the management of chest pain is not feasible in its current form. The CDSS was not used to support decisions about the care of individual patients. A range of barriers to the use of the CDSS were identified, some are easily removed, such as insufficient capture of cardiovascular risk, while others are more deeply embedded in current practice, such as unavailability of some investigations or no prescribing privileges for nurses.

Paranoia and Data-Gathering Biases in Autism.

Previous research has identified contradictory patterns in autism upon probabilistic reasoning tasks, and high levels of self-report paranoia symptoms have also been reported. To explore this relationship, the present study assessed 64 non-autistic and 39 autistic adults on two variants of a probabilistic reasoning task which examined the amount of evidence required before making a decision and 'jumping to conclusions' (a neutral beads task and an emotionally-salient words variant). The autism group was found to require significantly more evidence before making a decision and to have significantly less jumping to conclusions than the non-autistic group. For those with relatively low levels of paranoia, the emotionally-salient variant impacted on the non-autistic group, but not the autism group.

A pilot randomised controlled trial of cognitive behavioural therapy for antenatal depression.

BACKGROUND: Few trials have evaluated the effectiveness of psychological treatment in improving depression by the end of pregnancy. This is the first pilot randomised controlled trial (RCT) of individual cognitive behavioural therapy (CBT) looking at treating depression by the end of pregnancy. Our aim was to assess the feasibility of delivering a CBT intervention modified for antenatal depression during pregnancy. METHODS: Women in North Bristol, UK between 8-18 weeks pregnant were recruited through routine contact with midwives and randomised to receive up to 12 sessions of individual CBT in addition to usual care or to continue with usual care only. Women were eligible for randomisation if they screened positive on a 3-question depression screen used routinely by midwives and met ICD-10 criteria for depression assessed using the clinical interview schedule - revised version (CIS-R). Two CBT therapists delivered the intervention. Follow-up was at 15 and 33 weeks post-randomisation when assessments of mental health were made using measures which included the CIS-R. RESULTS: Of the 50 women assessed for the trial, 36 met ICD-10 depression criteria and were randomised: 18 to the intervention and 18 to usual care. Thirteen of the 18 (72%) women who were allocated to receive the intervention completed 9 or more sessions of CBT before the end of pregnancy. Follow-up rates at 15 and 33 weeks post-randomisation were higher in the group who received the intervention (89% vs. 72% at 15 weeks and 89% vs. 61% at 33 weeks post-randomisation). At 15 weeks post-randomisation (the end of pregnancy), there were more women in the intervention group (11/16; 68.7%) who recovered (i.e. no longer met ICD-10 criteria for depression), than those receiving only usual care (5/13; 38.5%). CONCLUSIONS: This pilot trial shows the feasibility of conducting a large RCT to assess the effectiveness of CBT for treating antenatal depression before the end of pregnancy. The intervention could be delivered during the antenatal period and there was some evidence to suggest that it could be effective. TRIAL REGISTRATION: ISRCTN44902048.

Involving lay and professional stakeholders in the development of a research intervention for the DEPICTED study.

AIM This paper focuses on stakeholders' active involvement at key stages of the research as members of a Stakeholder Action Group (SAG), particularly in the context of lay stakeholder involvement. Some challenges that can arise and wider issues (e.g. empowerment, the impact of user involvement) are identified and explored within the literature on service user involvement in health care research, reflecting on the implications for researchers. BACKGROUND In the DEPICTED study, lay and professional stakeholders were actively involved in developing a complex research intervention. Lay stakeholders comprised teenage and adult patients with diabetes, parents and patient organization representatives. Professional stakeholders were from a range of disciplines. METHODS Three 1-day research meetings were attended by 13-17 lay stakeholders and 10-11 professional stakeholders (plus researchers). The SAG was responsible for reviewing evidence, advising on developing ideas for the research intervention and guiding plans for evaluation of the intervention in a subsequent trial. Formal evaluations were completed by stakeholders following each SAG meeting. RESULTS Throughout the first (developmental) stage of this two-stage study, lay and professional stakeholders participated or were actively involved in activities that provided data to inform the research intervention. Lay stakeholders identified the need for and contributed to the design of a patient-held tool, strongly influenced the detailed design and content of the research intervention and outcome questionnaire, thus making a major contribution to the trial design. CONCLUSION Stakeholders, including teenagers, can be actively involved in designing a research intervention and impact significantly on study outcomes.

Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED): a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes.

BACKGROUND: Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team. METHODS/DESIGN: Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period. DISCUSSION: The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61568050.

Understanding tensions and identifying clinician agreement on improvements to early-stage chronic kidney disease monitoring in primary care: a qualitative study.

OBJECTIVES: Since 2006, general practitioners (GPs) in England, UK, have been incentivised to keep a register and monitor patients with chronic kidney disease (CKD) stages 3-5. Despite tensions and debate around the merit of this activity, there has been little qualitative research exploring clinician perspectives on monitoring early-stage CKD in primary care. This study aimed to examine and understand a range of different healthcare professional views and experiences of identification and monitoring in primary care of early-stage CKD, in particular stage 3. DESIGN: Qualitative design using semistructured interviews. SETTING: National Health Service (NHS) settings across primary and secondary care in South West England, UK. PARTICIPANTS: 25 clinicians: 16 GPs, 3 practice nurses, 4 renal consultants and 2 public health physicians. RESULTS: We identified two related overarching themes of dissonance and consonance in clinician perspectives on early-stage CKD monitoring in primary care. Clinician dissonance around clinical guidelines for CKD monitoring emanated from different interpretations of CKD and different philosophies of healthcare and moral decision-making. Clinician consonance centred on the need for greater understanding of renal decline and increasing proteinuria testing to reduce overdiagnosis and identify those patients who were at risk of progression and further morbidity and who would benefit from early intervention. Clinicians recommended adopting a holistic approach for patients with CKD representing a barometer of overall health. CONCLUSIONS: The introduction of new National Institute for Health and Care Excellence (NICE) CKD guidelines in 2014, which focus the meaning and purpose of CKD monitoring by increased proteinuria testing and assessment of risk, may help to resolve some of the ethical and moral tensions clinicians expressed regarding the overmedicalisation of patients with a CKD diagnosis.

The effect of the Talking Diabetes consulting skills intervention on glycaemic control and quality of life in children with type 1 diabetes: cluster randomised controlled trial (DEPICTED study).

OBJECTIVE: To evaluate the effectiveness on glycaemic control of a training programme in consultation skills for paediatric diabetes teams. DESIGN: Pragmatic cluster randomised controlled trial. SETTING: 26 UK secondary and tertiary care paediatric diabetes services. PARTICIPANTS: 79 healthcare practitioners (13 teams) trained in the intervention (359 young people with type 1 diabetes aged 4-15 years and their main carers) and 13 teams allocated to the control group (334 children and their main carers). INTERVENTION: Talking Diabetes programme, which promotes shared agenda setting and guiding communication style, through flexible menu of consultation strategies to support patient led behaviour change. MAIN OUTCOME MEASURES: The primary outcome was glycated haemoglobin (HbA(1c)) level one year after training. Secondary outcomes were clinical measures (hypoglycaemic episodes, body mass index, insulin regimen), general and diabetes specific quality of life, self reported and proxy reported self care and enablement, perceptions of the diabetes team, self reported and carer reported importance of, and confidence in, undertaking diabetes self management measured over one year. Analysis was by intention to treat. An integrated process evaluation included audio recording a sample of 86 routine consultations to assess skills shortly after training (intervention group) and at one year follow-up (intervention and control group). Two key domains of skill assessment were use of the guiding communication style and shared agenda setting. RESULTS: 660/693 patients (95.2%) provided blood samples at follow-up. Training diabetes care teams had no effect on HbA(1c) levels (intervention effect 0.01, 95% confidence interval -0.02 to 0.04, P=0.5), even after adjusting for age and sex of the participants. At follow-up, trained staff (n=29) were more capable than controls (n=29) in guiding (difference in means 1.14, P<0.001) and agenda setting (difference in proportions 0.45, 95% confidence interval 0.22 to 0.62). Although skills waned over time for the trained practitioners, the reduction was not significant for either guiding (difference in means -0.33, P=0.128) or use of agenda setting (difference in proportions -0.20, -0.42 to 0.05). 390 patients (56%) and 441 carers (64%) completed follow-up questionnaires. Some aspects of diabetes specific quality of life improved in controls: reduced problems with treatment barriers (mean difference -4.6, 95% confidence interval -8.5 to -0.6, P=0.03) and with treatment adherence (-3.1, -6.3 to -0.01, P=0.05). Short term ability to cope with diabetes increased in patients in intervention clinics (10.4, 0.5 to 20.4, P=0.04). Carers in the intervention arm reported greater excitement about clinic visits (1.9, 1.05 to 3.43, P=0.03) and improved continuity of care (0.2, 0.1 to 0.3, P=0.01). CONCLUSIONS: Improving glycaemic control in children attending specialist diabetes clinics may not be possible through brief, team-wide training in consultation skills. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61568050.

(Mis)alignments in counseling for Huntington's Disease predictive testing: clients' responses to reflective frames.

As a sequel to an earlier paper (Sarangi et al., 2004. J Genet Couns, 13(2), 135-155) examining genetic counselors' initiation of reflective frames, in this paper we analyze the variable ways in which clients respond to such reflective frames in the clinical setting. Of the six types of reflective questions identified, we focus on two types, which recur throughout the counseling protocol: (i) questions about clients' decisions to have genetic testing and (ii) questions exploring the potential impact of a positive or negative test result. The analytic focus here is on the mismatches surrounding clients' apparent readiness to discuss coping with the onset of disease (risk of disease) when they have been asked to discuss coping with genetic test results (risk of knowing). Our theoretical discussion is centered around the notion of alignment as a framework for locating the convergence and divergence of counselors' and clients' agendas in interaction. Drawing on detailed transcripts of 24 Huntington's Disease counseling consultations in South Wales, we analyze 119 counselor-client question-response sequences using the methodology of discourse analysis. Preliminary coding of clients' responses led us to identify three recurrent themes: (a) gaining knowledge as a basis for future action; (b) needing to know as a subjective necessity; and (c) downplaying what can be known. In a further analysis of extended data extracts, we draw attention to how clients display varying degrees of engagement with regard to the testing process and outcomes along the temporal and social axes. At one extreme, clients may take up the opportunity to engage in self-reflection, and thus endorse the legitimacy of the reflective frame. At the other extreme, clients may implicitly or explicitly challenge the relevance of self-reflection, and hence the usefulness of this counselor-initiated routine. We suggest that clients' varied response behaviors result from the perceived need of some clients to display their 'readiness' for predictive testing-an overarching 'meta-question' posed by the very existence of the counseling protocol.

Initiation of reflective frames in counseling for Huntingtons Disease predictive testing.

Genetic professionals and clients are likely to assign different meanings to the extended format of the counseling protocols for predictive testing. In order to facilitate informed, client-centered decisions about the possibility of predictive testing, counselors routinely use the question format to initiate what we call "reflective frames" that invite clients to discuss their feelings and encourage them to adopt introspective and self-reflective stances toward their own experience--spanning the past, the present, and the hypothetical future. We suggest that such initiations of reflective frames constitute a key element of counselors' nondirective stance, although the exact nature of their formulations can be complex and varied. Examining 24 Huntington's Disease (HD) clinic sessions involving 12 families in South Wales with the tools of discourse analysis, our focus in this paper is twofold: (i) to propose a classification of six types of reflective questions (e.g. nonspecific invites, awareness and anxiety, decision about testing, impact of result, dissemination, and other) and to examine their distribution across the various clinic appointments, and (ii) to investigate the scope of these questions in terms of temporal and social axes. We link our analysis to the current debate within the genetic counseling profession about the merits of reflection- versus information-focused counseling styles and the need to abide by professionally warranted and institutionally embedded counseling protocols.