Educational interventions aiming at improving adherence to treatment recommendations in type 2 diabetes: A sub-analysis of a systematic review of randomised controlled trials.

OBJECTIVE: In the management of type 2 diabetes, a complex interaction takes place between medical professionals' treatment goals and patients' health beliefs about the disease and its treatment options. The contribution of self-management education to adherence in general or even more specifically to medicine taking is not known. We assessed educational interventions aimed at improving adherence to medical treatment recommendations, other than lifestyle advice. STUDY DESIGN: Systematic literature review. SETTING: This paper represents an analysis of eight articles describing an educational intervention as a subgroup of a Cochrane Review [E. Vermeire, J. Wens, P. Van Royen, Y. Biot, H. Hearnshaw, A. Lindenmeyer, Interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus, Cochrane Database of Systematic Reviews 2005, Issue 2, Art. No.: CD003638, doi:10.1002/14651858.CD003638.pub2] on interventions to improve adherence to treatment recommendations in people with type 2 diabetes. RESULTS: Four studies reported interventions using face-to-face education, two reported on the effects of group education and two on distance education by telemedicine. Due to poor quality of study designs, a variety of heterogeneous outcome measures in different time intervals, unclear definitions of adherence, and difficulties in evaluating different aspects of education performed, general conclusions could not be drawn. CONCLUSION: Consistent conclusions about the effectiveness of educational interventions on adherence to treatment recommendations were hard to be drawn. There is an urgent need for well-designed intervention studies on the effect of different aspects of education on adherence to treatment recommendations.

Stakeholder perspectives on the development of a virtual clinic for diabetes care: qualitative study.

BACKGROUND: The development of the Internet has created new opportunities for health care provision, including its use as a tool to aid the self-management of chronic conditions. We studied stakeholder reactions to an Internet-based "virtual clinic," which would allow people with diabetes to communicate with their health care providers, find information about their condition, and share information and support with other users. OBJECTIVE: The aim of the study was to present the results of a detailed consultation with a variety of stakeholder groups in order to identify what they regard as the desirable, important, and feasible characteristics of an Internet-based intervention to aid diabetes self-management. METHODS: Three focus groups were conducted with 12 people with type 1 diabetes who used insulin pumps. Participants were recruited through a local diabetes clinic. One-on-one interviews were conducted with 5 health care professionals from the same clinic (2 doctors, 2 nurses, 1 dietitian) and with 1 representative of an insulin pump company. We gathered patient consensus via email on the important and useful features of Internet-based systems used for other chronic conditions (asthma, epilepsy, myalgic encephalopathy, mental health problems). A workshop to gather expert consensus on the use of information technology to improve the care of young people with diabetes was organized. RESULTS: Stakeholder groups identified the following important characteristics of an Internet-based virtual clinic: being grounded on personal needs rather than only providing general information; having the facility to communicate with, and learn from, peers; providing information on the latest developments and news in diabetes; being quick and easy to use. This paper discusses these characteristics in light of a review of the relevant literature. The development of a virtual clinic for diabetes that embodies these principles, and that is based on self-efficacy theory, is described. CONCLUSIONS: Involvement of stakeholders is vital early in the development of a complex intervention. Stakeholders have clear and relevant views on what a virtual clinic system should provide, and these views can be captured and synthesized with relative ease. This work has led to the design of a system that is able to meet user needs and is currently being evaluated in a pilot study.

Assessment of the benefits of user involvement in health research from the Warwick Diabetes Care Research User Group: a qualitative case study.

OBJECTIVE: To assess the benefits of involving health-care users in diabetes research. DESIGN AND PARTICIPANTS: For this qualitative case study, semi-structured interviews were conducted with researchers who had worked extensively with the group. During regular meetings of the Research User Group, members discussed their views of the group's effectiveness as part of the meeting's agenda. Interviews and discussions were transcribed, coded using N-Vivo software and analysed using constant comparative methods. RESULTS: Involvement of users in research was generally seen as contributing to effective and meaningful research. However, the group should not be considered to be representative of the patient population or participants of future trials. An important contributor to the group's success was its longstanding nature, enabling users to gain more insight into research and form constructive working relationships with researchers. The user-led nature of the group asserted itself, especially, in the language used during group meetings. A partial shift of power from researchers to users was generally acknowledged. Users' main contribution was their practical expertise in living with diabetes, but their involvement also helped researchers to remain connected to the 'real world' in which research would be applied. While the group's work fulfilled established principles of consumer involvement in research, important contributions relying on personal interaction between users and researchers were hard to evaluate by process measures alone. CONCLUSIONS: We demonstrated the feasibility, acceptability and effectiveness of this longstanding, experienced, lay-led research advisory group. Its impact on research stems from the continuing interaction between researchers and users, and the general ethos of learning from each other in an on-going process. Both process measures and qualitative interviews with stakeholders are needed to evaluate the contributions of service users to health research.

Telecare motivational interviewing for diabetes patient education and support: a randomised controlled trial based in primary care comparing nurse and peer supporter delivery.

BACKGROUND: There is increasing interest in developing peer-led and 'expert patient'-type interventions, particularly to meet the support and informational needs of those with long term conditions, leading to improved clinical outcomes, and pressure relief on mainstream health services. There is also increasing interest in telephone support, due to its greater accessibility and potential availability than face to face provided support. The evidence base for peer telephone interventions is relatively weak, although such services are widely available as support lines provided by user groups and other charitable services. METHODS/DESIGN: In a 3-arm RCT, participants are allocated to either an intervention group with Telecare service provided by a Diabetes Specialist Nurse (DSN), an intervention group with service provided by a peer supporter (also living with diabetes), or a control group receiving routine care only. All supporters underwent a 2-day training in motivational interviewing, empowerment and active listening skills to provide telephone support over a period of up to 6 months to adults with poorly controlled type 2 diabetes who had been recommended a change in diabetes management (i.e. medication and/or lifestyle changes) by their general practitioner (GP). The primary outcome is self-efficacy; secondary outcomes include HbA1c, total and HDL cholesterol, blood pressure, body mass index, and adherence to treatment. 375 participants (125 in each arm) were sought from GP practices across West Midlands, to detect a difference in self-efficacy scores with an effect size of 0.35, 80% power, and 5% significance level. Adults living with type 2 diabetes, with an HbA1c > 8% and not taking insulin were initially eligible. A protocol change 10 months into the recruitment resulted in a change of eligibility by reducing HbA1c to > 7.4%. Several qualitative studies are being conducted alongside the main RCT to describe patient, telecare supporter and practice nurse experience of the trial. DISCUSSION AND IMPLICATIONS OF THE RESEARCH: With its focus on self-management and telephone peer support, the intervention being trialled has the potential to support improved self-efficacy and patient experience, improved clinical outcomes and a reduction in diabetes-related complications. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN63151946.

Obstacles to adherence in living with type-2 diabetes: an international qualitative study using meta-ethnography (EUROBSTACLE).

Quantitative studies failed to determine variables which consistently explain adherence or non-adherence to treatment recommendations. Qualitative studies identified issues such as the quality of the health provider-health receiver relationship and the patient's health beliefs. According to these findings, 39 focus groups of 246 people living with type-2 diabetes were conducted in seven European countries, assessing health beliefs, communication with caregivers and problems encountered in adhering to treatment regimens. Meta-ethnography was later applied to make a qualitative meta-analysis. Obstacles to adherence are common across countries, and seem to be related less to issues of the health-care system and more to patient's knowledge about diabetes, beliefs and attitudes and the relationship with health-care professionals. The resulting key themes are course of diabetes, information, person and context, body awareness and relationship with the health care provider. Meta-ethnography is a feasible tool for the meta-analysis of multilingual qualitative data and leads to a richer account.

The Diabetes Manual trial protocol - a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411].

BACKGROUND: The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. METHODS/DESIGN: In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months) and following an agreed protocol change over 7% (months 13 to 18). Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. DISCUSSION: This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.

Complex intervention development for diabetes self-management.

AIM: The aim of this paper is to present the development and evaluation of the Self-Efficacy Goal Achievement nursing intervention for type 2 diabetes. BACKGROUND: Systematic reviews support the clinical effectiveness of diabetes self-management programmes that are collaborative, involve biomedical feedback and are goal focussed. METHOD: The self-efficacy goal achievement intervention comprises patient goal-setting consultations with practice nurses using the Diabetes Management Self-Efficacy Scale. The United Kingdom Medical Research Council framework for the evaluation of complex interventions by randomized controlled trial was used to develop and evaluate the intervention. The 'preclinical' study included literature analysis and findings from parallel studies. The 'phase I' study, carried out in spring 2003, was a small trial of the intervention, evaluation of its feasibility, identification of appropriate outcome measures for future trials and improvement of the components, with two nurses and eight patients. FINDINGS: The 'preclinical' study supported continued intervention development. The 'phase I' intervention resulted in a mean reduction in participants' glycosylated haemoglobin of 0.93% between baseline and 3-months postintervention. It showed an increase in patient self-efficacy and some decline in patient diabetes treatment satisfaction. Qualitative data recorded therapeutically desirable behavioural changes in all participants. Follow-up consultations and goal evaluation were found to be important to patients. Nurses reported (i) reservations about the repeated use of components of the intervention, which were felt to be repetitive and restrictive; and (ii) the time commitment required to deliver the educational sessions. CONCLUSIONS: Most phase I components were effective in delivering a feasible nursing intervention. The intervention has been adjusted to remove the less effective components and enhance the more effective. The outcome measures were appropriate for the intervention. A phase II trial is being developed to further test both the intervention and research protocol for comparing the intervention to an alternative.

Can a facilitated programme promote effective multidisciplinary audit in secondary care teams? An exploratory trial.

This 24-month exploratory study evaluated whether a 6-month programme supported by a trained external facilitator was feasible, acceptable and led to the adoption of a multidisciplinary approach to audit by secondary care staff. Undertaken in five acute hospital sites in the East Midlands UK, 22 multidisciplinary teams were randomised to either an intervention or control arm. Employing mixed methods, a range of outcomes, including collaborative behaviour, was measured. The intervention was feasible and acceptable to staff. Involvement in the facilitated programme had a positive impact on self-reported knowledge (P=0.000 post-intervention and at 4-months follow-up), skills (P=0.000 post-intervention and P=0.02 at 4-months follow-up) and attitudes (P<0.01 post-intervention), appeared to have some influence on improving self-reported (P<0.05 post-intervention) and observed collaborative behaviour (P=0.01) and led to better quality audit resulting in measurable improvements to care. Improved collaborative behaviour may have resulted from an increase in assertive behaviour by nurses. Research to test approaches to support teams to work effectively together is currently hampered by a lack of suitable research instruments and needs addressing before main (phase 111) trials are undertaken.

Attitudes of young people with diabetes to an Internet-based virtual clinic.

We assessed the feasibility of developing a virtual diabetes clinic for young people, using the Internet. The proposed content of the site would be based on self-efficacy theory, aiming to develop confidence in self-management of diabetes. A questionnaire about the proposed Website was delivered to 72 patients who attended a young person's outpatient clinic in a district hospital. Thirty-nine replies were received, a response rate of 54%. The mean age of the respondents was 13 years. A positive attitude to the potential clinic was reported by 95% of respondents. The items rated as most useful were: quick and easy access to up-to-date information about diabetes; the opportunity to ask an expert; good graphics; easy navigation; interactivity. Responses to open questions indicated that 24-hour access and anonymity in asking questions were also valued. A virtual clinic appears to be a possible method of health-care delivery to young people with diabetes.

Heart failure in primary care: qualitative study of current management and perceived obstacles to evidence-based diagnosis and management by general practitioners.

BACKGROUND: Chronic heart failure is a common clinical condition with high morbidity and mortality. Despite the evidence that appropriate treatment with angiotensin-converting enzyme inhibitors can improve morbidity, primary care studies show that patients with heart failure are incorrectly diagnosed and inadequately treated. AIM: To explore general practitioners' accounts of their management of patients with heart failure and identify the perceived obstacles to diagnosis and management. METHODS: We conducted this qualitative study using semi-structured interviews in 18 general practices. The practices were stratified on the basis of size, location, and the level of practice development. The interviews were based on a schedule of open questions based on the literature on diagnosis and management of patients with heart failure. Transcriptions of the audiotaped interviews were independently analysed by two researchers and analysis was based on open coding using a constant comparative approach. Categories were reduced to major themes. RESULTS: General practitioners suspect heart failure when patients present with breathlessness or ankle oedema. Many general practitioners reported that they would diagnose heart failure after respiratory examination and a positive finding of basal crepitations. Many general practitioners arrange a chest X-ray to establish the diagnosis and some arrange an electrocardiogram. A few general practitioners mentioned that they diagnosed heart failure with a trial of diuretics. Obstacles to diagnosis were mentioned by most general practitioners and included lack of facilities for appropriate investigations (especially echocardiography) and lack of time and expertise. Obstacles to management included lack of time, high cost of drugs, difficulty with diagnosis, selection bias towards younger patients and not having the confidence to initiate angiotensin-converting enzyme inhibitors. Many general practitioners were unaware of the impact angiotensin-converting enzyme inhibitors can have on morbidity and mortality. CONCLUSIONS: Although symptoms of heart failure are not sufficiently specific for diagnosing patients with heart failure, many general practitioners in European countries treat people with suspected heart failure on the basis of symptoms and signs alone. This study has identified many obstacles to the diagnosis and management of heart failure that may explain why patients are inadequately managed in primary care. Specific implementation strategies need to be tailored to overcome these obstacles.

Patient satisfaction with availability of general practice: an international comparison.

OBJECTIVE: To identify associations between the characteristics of general practitioners and practices, and patients' evaluations of the availability of general practice. DESIGN: Written surveys completed by patients. SETTING: General practice care in nine European countries: Denmark, Germany, The Netherlands, Norway, UK, Belgium (Flanders and Wallonia), Switzerland, Slovenia and Spain. STUDY PARTICIPANTS: 15996 adult patients consecutively visiting the general practitioner (response rates per country varied between 47 and 89%). MAIN MEASURES: The Europep instrument to assess patients' evaluations of five aspects of the availability of general practice care: (1) getting an appointment, (2) getting through on the phone, (3) being able to speak to the practitioner on the telephone, (4) waiting time in the waiting room, and (5) providing quick services for urgent health problems. Each general practitioner recorded age, sex, number of years in the practice, number of practitioners and other care providers in the practice, and urbanization level of the practice. RESULTS: Patients' more positive evaluations were associated with fewer general practitioners in the practice, except for quick services for urgent health problems (range of conditional overall odds ratios, 1.69-2.02). In addition, a number of significant unconditional overall odds ratios were found, particularly those related to the number of general practitioners' working hours and the number of care providers in the practice. None of the associations was found consistently in all countries. CONCLUSION: Patients favour small practices and full-time general practitioners, which contradicts developments in general practice in many countries. Policy makers should consider how the tensions between patients' views and organizational developments can be solved.