Jonathan Graffy

Randomised controlled trial of support from volunteer counsellors for mothers considering breast feeding

Abstract Objective To investigate whether offering volunteer support from counsellors in breast feeding would result in more women breast feeding. Design Randomised controlled trial. Setting 32 general practices in London and south Essex. Participants 720 women considering breast feeding. Main outcome measures Primary outcome was prevalence of any breast feeding at six weeks. Secondary outcomes were the proportion of women giving any breast feeds, or bottle feeds at four months, duration of any breast feeding, time to introduction of bottle feeds, and satisfaction with breast feeding. Results Offering support in breast feeding did not significantly increase the prevalence of any breast feeding to six weeks (65% (218/336) in the intervention group and 63% (213/336) in the control group; relative risk 1.02, 95% confidence interval 0.84 to 1.24). Survival analysis up to four months confirmed that neither duration of breast feeding nor time to introduction of formula feeds differed significantly between control and intervention groups. Not all women in the intervention group contacted counsellors postnatally, but 73% (123/179) of those who did rated them as very helpful. More women in the intervention group than in the control group said that their most helpful advice came from counsellors rather than from other sources. Conclusions Women valued the support of a counsellor in breast feeding, but the intervention did not significantly increase breastfeeding rates, perhaps because some women did not ask for help.

An explanatory randomised controlled trial of a nurse-led, consultation-based intervention to support patients with adherence to taking glucose lowering medication for type 2 diabetes

BackgroundFailure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention to support objectively-assessed adherence to oral glucose lowering medication (OGLM) compared to usual care among people with type 2 diabetes.MethodsThis was a parallel group randomised trial in adult patients with type 2 diabetes and HbA1c≥7.5% (58 mmol/mol), prescribed at least one OGLM. Participants were allocated to a clinic nurse delivered, innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans, or to usual care. The primary outcome was the percentage of days on which the prescribed dose of medication was taken, measured objectively over 12 weeks with an electronic medication-monitoring device (TrackCap, Aardex, Switzerland). The primary analysis was intention-to-treat.Results211 patients were randomised between July 1, 2006 and November 30, 2008 in 13 British general practices (primary care clinics). Primary outcome data were available for 194 participants (91.9%). Mean (sd) percentage of adherent days was 77.4% (26.3) in the intervention group and 69.0% (30.8) in standard care (mean difference between groups 8.4%, 95% confidence interval 0.2% to 16.7%, p = 0.044). There was no significant adverse impact on functional status or treatment satisfaction.ConclusionsThis well-specified, theory based intervention delivered in a single session of 30 min in primary care increased objectively measured medication adherence, with no adverse effect on treatment satisfaction. These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time, with clinical and cost-effectiveness outcomes to inform clinical practice.Trial registrationCurrent Controlled Trials ISRCTN30522359

Impact of Community Based Peer Support in Type 2 Diabetes: A Cluster Randomised Controlled Trial of Individual and/or Group Approaches

Background Diabetes peer support, where one person with diabetes helps guide and support others, has been proposed as a way to improve diabetes management. We have tested whether different diabetes peer support strategies can improve metabolic and/or psychological outcomes. Methods People with type 2 diabetes (n = 1,299) were invited to participate as either ‘peer’ or ‘peer support facilitator’ (PSF) in a 2x2 factorial randomised cluster controlled trial across rural communities (130 clusters) in England. Peer support was delivered over 8–12 months by trained PSFs, supported by monthly meetings with a diabetes educator. Primary end point was HbA1c. Secondary outcomes included quality of life, diabetes distress, blood pressure, waist, total cholesterol and weight. Outcome assessors and investigators were masked to arm allocation. Main factors were 1:1 or group intervention. Analysis was by intention-to-treat adjusting for baseline. Results The 4 arms were well matched (Group n = 330, 1:1(individual) n = 325, combined n = 322, control n = 322); 1035 (79•7%) completed the mid-point postal questionnaire and 1064 (81•9%) had a final HbA1c. A limitation was that although 92.6% PSFs and peers were in telephone contact, only 61.4% of intervention participants attended a face to face session. Mean baseline HbA1c was 57 mmol/mol (7•4%), with no significant change across arms. Follow up systolic blood pressure was 2•3mm Hg (0.6 to 4.0) lower among those allocated group peer-support and 3•0mm Hg (1.1 to 5.0) lower if the group support was attended at least once. There was no impact on other outcomes by intention to treat or significant differences between arms in self-reported adherence or medication. Conclusions Group diabetes peer support over 8–12 months was associated with a small improvement in blood pressure but no other significant outcomes. Long term benefits should be investigated. Trial Registration ISRCTN.com ISRCTN6696362166963621

Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials.

BackgroundRandomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts.Methods/DesignThe Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies.DiscussionSuccessful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention.Trial registrationThe START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.

How Primary Care Networks Can Help Integrate Academic and Service Initiatives in Primary Care

PURPOSE Theory of effective network operation in primary care is underdeveloped. This study aimed to identify how primary care networks can best integrate academic and service initiatives. METHODS We performed a comparative case study of 4 primary care research networks in North London, England, for the years 1998–2002. Indicators were selected to assess changes in (1) research capacity, (2) multidisciplinary collaboration, and (3) research productivity. We compared the profiles of network outcome with descriptions of their contexts and organizational types from a previous evaluation. RESULTS Together, the networks supported 133 viable projects and 30 others; 399 practitioners, managers, and academics participated in the research teams. How the networks organized themselves was influenced by the circumstances in which they were formed. Different ways of organizing were associated with different outcome profiles. Shared projects and learning spaces helped participants to develop trusted relationships. A top-down, hierarchical approach based on institutional alliances and academic expertise attracted more funding and appeared to be stable. The bottom-up, individualistic network with research practices was good at reflecting on practical primary care concerns. Whole-system methods brought together stakeholder contributions from all parts of the system. CONCLUSIONS Networks can help integrate academic research and service development initiatives by facilitating interorganizational interactions and in shared leadership of projects. Researchers and practitioners stand to gain considerably from an integrated approach in both the short and the long term. Success requires agreement about a set of pathways, learning spaces, and feedback mechanisms to harness the insights and efforts of stakeholders throughout the whole system.

Testing a peer support intervention for people with type 2 diabetes: a pilot for a randomised controlled trial

BackgroundPeople with Type 2 diabetes face various psycho-social, self-management and clinical care issues and evidence is mixed whether support from others with diabetes, ‘peer support’, can help. We now describe a 2 month pilot study of different peer support interventions.MethodsThe intervention was informed by formative evaluation using semi-structured interviews with health professionals, community support groups and observation of diabetes education and support groups. Invitations to participate were mailed from 4 general practices and included a survey of barriers to care. Participants were randomized by practice to receive individual, group, combined (both individual and group) or no peer support. Evaluation included ethnographic observation, semi-structured interviews and questionnaires at baseline and post-intervention.ResultsOf 1,101 invited, 15% expressed an interest in participating in the pilot. Sufficient numbers volunteered to become peer supporters, although 50% of these (8/16) withdrew. Those in the pilot were similar to other patients, but were less likely to feel they knew enough about diabetes (60.8% vs 44.6% p = 0.035) and less likely to be happy with the diabetes education/care to date (75.4% vs 55.4% p = 0.013). Key issues identified were the need to recruit peer supporters directly rather than through clinicians, to address participant diabetes educational needs early and the potential for group sessions to have lower participation rates than 1:1 sessions.ConclusionsRecruitment to a full trial of peer support within the existing study design is feasible with some amendments. Attendance emerged as a key issue needing close monitoring and additional intervention during the trial.

Clinical effectiveness and cost-effectiveness of tailored intensive liaison between primary and secondary care to identify individuals at risk of a first psychotic illness (the LEGs study): a cluster-randomised controlled trial

Summary Background General practitioners are usually the first health professionals to be contacted by people with early signs of psychosis. We aimed to assess whether increased liaison between primary and secondary care improves the clinical effectiveness and cost-effectiveness of detection of people with, or at high risk of developing, a first psychotic illness. Methods Our Liaison and Education in General Practices (LEGs) study was a cluster-randomised controlled trial of primary care practices (clusters) in Cambridgeshire and Peterborough, UK. Consenting practices were randomly allocated (1:1) to a 2 year low-intensity intervention (a postal campaign, consisting of biannual guidelines to help identify and refer individuals with early signs of psychosis) or a high-intensity intervention, which additionally included a specialist mental health professional who liaised with every practice and a theory-based educational package. Practices were not masked to group allocation. Practices that did not consent to be randomly assigned comprised a practice-as-usual (PAU) group. The primary outcome was number of referrals of patients at high risk of developing psychosis to the early intervention service per practice site. New referrals were assessed clinically and stratified into those who met criteria for high risk or first-episode psychotic illness (FEP; together: psychosis true positives), and those who did not fulfil such criteria for psychosis (false positives). Referrals from PAU practices were also analysed. We assessed cost-effectiveness with decision analytic modelling in terms of the incremental cost per additional true positive identified. The trial is registered at the ISRCTN registry, number ISRCTN70185866. Findings Between Dec 22, 2009, and Sept 7, 2010, 54 of 104 eligible practices provided consent and between Feb 16, 2010, and Feb 11, 2011, these practices were randomly allocated to interventions (28 to low intensity and 26 to high intensity); the remaining 50 practices comprised the PAU group. Two high-intensity practices were excluded from the analysis. In the 2 year intervention period, high-intensity practices referred more FEP cases than did low-intensity practices (mean 1·25 [SD 1·2] for high intensity vs 0·7 [0·9] for low intensity; incidence rate ratio [IRR] 1·9, 95% CI 1·05–3·4, p=0·04), although the difference was not statistically significant for individuals at high risk of psychosis (0·9 [1·0] vs 0·5 [1·0]; 2·2, 0·9–5·1, p=0·08). For high risk and FEP combined, high-intensity practices referred both more true-positive (2·2 [1·7] vs 1·1 [1·7]; 2·0, 1·1–3·6, p=0·02) and false-positive (2·3 [2·4] vs 0·9 [1·2]; 2·6, 1·3–5·0, p=0·005) cases. Referral patterns did not differ between low-intensity and PAU practices. Total cost per true-positive referral in the 2 year follow-up was £26 785 in high-intensity practices, £27 840 in low-intensity practices, and £30 007 in PAU practices. Interpretation This intensive intervention to improve liaison between primary and secondary care for people with early signs of psychosis was clinically and cost effective. Funding UK National Institute for Health Research.

Personalized care planning for diabetes : policy lessons from systematic reviews of consultation and self-management interventions

Aim To determine whether a process of care planning for people with diabetes, combining a patient-centred approach by practitioners with measures to promote self-management by patients, improve health outcomes. Background Health policy, in many countries, seeks to engage people with long-term conditions in protecting their health. This review was conducted by members of a working group established by the Department of Health and Diabetes, UK to consider the potential for personalized care planning in UK diabetes services. Methods Review of systematic reviews. The Cochrane Library and Database of Reviews of Effectiveness were searched to identify reviews concerned with components of care planning. Reviews conducted before 1990, and those involving education outside the consultation were excluded. Abstracts were reviewed and data extraction undertaken by reviewers working independently in pairs. Results In all, 86 reviews were identified as potentially relevant and 22 included. Patient-focused interventions, such as pre-consultation prompts, enhanced the role patients played in consultations. Personalized approaches using tailored information influenced health behaviour more than uniform approaches. Decision aids and computerized knowledge management improved the process of decision-making. Although effective communication was important, focusing solely on changing practitioner behaviour appeared inadequate. Taken together, there was good evidence that the processes involved in personalized care planning would engage patients more effectively in managing their care, but little robust research on the impact on health outcomes of doing so. Conclusions The present review identifies effective interventions that are available for clinicians to use in diabetes consultations, but engaging patients requires more than this. Mechanisms to share information and decision-making need further development and evaluation to assess their impact on health outcomes. Narrowly targeted interventions focused on practitioner behaviour appear less effective than whole-system approaches. Personalized care planning offers a mechanism to integrate patient-centred medicine and support for self-management to improve diabetes care.

Emotional Support for Diabetes Management: An International Cross-Cultural Study

Purpose The purpose of this study was to explore how emotional support emerged in interactions between peer supporters (PSs) and adults living with type 2 diabetes. Methods Qualitative data were analyzed from 22 semistructured interviews with PSs in 3 settings: low-income Latinos in Chicago, middle-class Caucasians in the United Kingdom, and low-income African American women in North Carolina. Emotional support was defined as expressions of empathy, trust, and caring. Results Across all sites, emotional support gradually emerged over time, was often combined with informational support, and was conveyed both implicitly (through nonverbal actions connoting emotional acceptance; eg, a walk together without discussion of problems) and explicitly (eg, by reassurance or discussion of stressors). Cross-site differences did appear regarding the strategies to address barriers to diabetes management (eg, PSs in North Carolina and Chicago reported providing support for social stressors) and the role of PSs (eg, PSs in Chicago reported providing directive support). Conclusions Across different settings and populations, emotional support for diabetes management evolved over time, was often integrated with informational support, and emerged through both implicit and explicit strategies that addressed varied context-specific stressors.

Barriers to medication adherence for the secondary prevention of stroke: a qualitative interview study in primary care

Background Medications are highly effective at reducing risk of recurrent stroke, but success is influenced by adherence to treatment. Among survivors of stroke and transient ischaemic attack (TIA), adherence to medication is known to be suboptimal. Aim To identify and report barriers to medication adherence for the secondary prevention of stroke/TIA. Design and setting A qualitative interview study was conducted within general practice surgeries in the East of England, UK. Method Patients were approached by letter and invited to take part in a qualitative research study. Semi-structured interviews were undertaken with survivors of stroke, caregivers, and GPs to explore their perspectives and views around secondary prevention and perceived barriers to medication adherence. Key themes were identified using a grounded theory approach. Verbatim quotes describing the themes are presented here. Results In total, 28 survivors of stroke, including 14 accompanying caregivers and five GPs, were interviewed. Two key themes were identified. Patient level barriers included ability to self-care, the importance people attach to a stroke event, and knowledge of stroke and medication. Medication level barriers included beliefs about medication and beliefs about how pills work, medication routines, changing medications, and regimen complexity and burden of treatment. Conclusion Patients who have had a stroke are faced with multiple barriers to taking secondary prevention medications in UK general practice. This research suggests that a collaborative approach between caregivers, survivors, and healthcare professionals is needed to address these barriers and facilitate medication-taking behaviour.