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One-to-one structured education using the Diabetes Manual: Evidence of effectiveness

Jackie Sturt

The Diabetes Manual is a one-to-one structured education programme for people with type 2 diabetes. It aims to help them develop skills and confidence in the management of their condition quickly and progressively. It includes a 2-day facilitator training course to develop health professionals’ confidence in supporting people through the programme. The Diabetes Manual meets the national criteria for structured education. This article describes the development of the Manual and a randomised controlled trial that provides evidence of its effectiveness and acceptability. Data from patient records offer some information about how people with type 2 diabetes use the Diabetes Manual. Practice-nurse focus groups found the programme acceptable and feasible for use in clinical settings.

The provision of structured education for people with type 1 or type 2 diabetes is becoming mainstream for PCTs as a result of the publication of the NICE (2003) guidance and the joint Department of Health [DH]/Diabetes UK Patient Education Working Group report (DH, 2005). The national criteria for assessing structured education programmes (DH et al, 2006) are that they should:

  • Have a structured, written curriculum. 
  • Have trained educators. 
  • Be quality assured. 
  • Be audited. 

These criteria are fundamental to the work of the Diabetes Education Network (2008) in promoting good clinical practice. 

Despite national vigour in implementing structured education in primary care, the Healthcare Commission (2007) reported that only 11% of people with diabetes have accessed diabetes education. There have also been anecdotal reports from PCTs and clinicians that, despite sending invitations to individuals with a new diagnosis to attend group-based programmes as preferred by NICE, around 50% of those invited are not taking up the invitation. Furthermore, an updated systematic review (Loveman et al, 2008) indicates that there is a lot of work still to do in identifying the components of the most effective programmes, particularly in relation to training and quality assurance of diabetes education facilitators. 

This paper contributes to this body of evidence by describing the development and evaluation of a one-to-one structured education programme that offers an alternative tool for use by diabetes specialist nurses, diabetes lead practice nurses and other diabetes healthcare professionals in delivering education to a diverse population in primary care. 

The Diabetes Manual
The Diabetes Manual is a one-to-one structured education programme for people with type 2 diabetes, which aims to help them develop skills and confidence in the management of their condition quickly and progressively. The Diabetes Manual has five components, which can be summarised as follows:

  • A 2-day facilitator training course for health professionals.
  • A 12-week patient manual.
  • A relaxation CD.
  • A CD with frequently asked questions (FAQs) for people with diabetes and carers.
  • Telephone support from facilitators in weeks 1, 5 and 11. 

Details of these components are presented in Table 1

The Diabetes Manual is a 12-week structured education programme, with participants being guided towards using the programme for 1 hour each day. One hour is a realistic assessment of the time it takes to undertake some of the new behaviours and skills, for example learning to do blood glucose monitoring or building up the confidence to do it at work, or climbing the stairs in public buildings rather than taking the lift. People might also choose to spend some of this time reading the Manual or practising their relaxation skills using the CD. 

The Diabetes Manual meets the national criteria for structured education outlined earlier. Table 2 shows how the Manual meets these criteria. 

Development of the Manual
The Diabetes Manual components took more than 18 months to develop, in consultation with two expert panels. The first panel was formed of people with diabetes, and the second comprised health professionals who routinely provide diabetes care, psychologists, educators, exercise-on-prescription trainers and researchers. Both panels met four times with the writer of the workbook over the course of 12 months to develop and refine the text, making sure it was accurate, was evidence based, used the appropriate language and had content that was important to both panels. The scripts for the CDs and the training curriculum were also scrutinised by the expert panels. 

Following the complete drafting, the programme was given to 12 people with diabetes who used it for 2 weeks and then joined a focus group to assess its face validity (including design and language), the validity of content, and its feasibility (Sturt et al, 2006a).

Effects of the Manual
The effects of the Diabetes Manual were evaluated in a randomised controlled trial (RCT) undertaken between 2004 and 2007 in 48 GP practices in the West Midlands (Sturt et al, 2006b; 2008). 

Aim of the trial
The aim of the trial was to assess the effectiveness of the Diabetes Manual against a deferred intervention control group, for improving glycaemic control, cardiovascular risk factors, self-efficacy and diabetes distress levels at 6 months and maintenance of effect at 12 months in the intervention group. A nested qualitative study aimed to assess its feasibility for delivery in primary care and to understand the ways in which people with diabetes engaged with it. 

Methods
General practices, drawn from 24 PCTs across the West Midlands, in which the practice nurse had undertaken post-registration diabetes care training were invited to participate. Adults with type 2 diabetes, not taking insulin, able to read and write English and a most recent HbA1c >7% were eligible to participate. Practices were computer randomised by a remote statistician to either the Diabetes Manual intervention group or a deferred intervention control group, whereby the latter would receive the intervention once the 6-month data collection was complete: baseline data are shown in Table 3. The primary outcome was between-group difference in HbA1c, and secondary outcomes were blood pressure, cholesterol level, BMI, diabetes distress (measured by the Problem Areas in Diabetes Scale [PAID]; Welch et al, 2003) and self-efficacy measured by the Diabetes Management Self-Efficacy Scale (DMSES; Sturt and Hearnshaw, 2003). The intervention participants were followed-up at 12 months to assess maintenance of effects. Further detailed description of the methods, outcomes measured, analysis methods and results can be found in the full RCT paper (Sturt et al, 2008).  

Results
Forty-eight GP practices participated and recruited 249 individuals, and 202 of these provided HbA1c data at the 6-month follow-up. Intervention group participants (n=88) were followed beyond 6 months, and 67 provided 12-month data.  

The between-group difference in HbA1c at 6 months was a reduction 0.08% in the intervention group, which was not significant (P=0.39). No statistically significant effects were detected between the groups in changes in blood pressure, cholesterol or BMI. On the psychological outcomes, the mean PAID score for all participants completing the study was lower by 4.5 points, indicating lowered diabetes-related distress in the intervention group compared with the delayed intervention group (P=0.012). The mean DMSES score was 11.2 points higher, indicating increased confidence to self-care in the intervention group compared with the delayed intervention group (P=0.0014). When intention-to-treat analysis was performed, the statistically significant difference remained between the groups (Sturt et al, 2008).

Results of the intervention group who were followed up to 12 months (Table 4), show a reduction of median HbA1c in this group at 6 months compared with baseline, and this remained lower at 12 months, however, the sample is too small to generalise from. 

Telephone support
The telephone support offered to participants in weeks 1, 5 and 11 of the programme was provided by their Diabetes Manual facilitator;  throughout the trial, this was the participant’s practice nurse.

The facilitators were asked to complete a telephone proforma after each of the three telephone support calls. On the proforma they recorded what self-care activity the individual was concentrating on, issues requiring support, intended goals for the following 4–6 week period and call length. 

Use of the Diabetes Manual
Twenty practice nurses completed 249 proformas following calls with 87 people with diabetes. The mean call duration was 9 minutes. Four researchers worked with 10 sets of proformas (that is, 10 individuals) to identify different types of Diabetes Manual user. Once the research team had reached agreement on the different types of user, the remaining sets of proformas were analysed independently by two researchers. A good level of agreement (80%) was reached between the two researchers in assessing the type of Diabetes Manual user that each set of proformas represented. 

Types of Diabetes Manual user
Three types of Diabetes Manual user were identified:

  • Embracers (n=24, 30%).
  • Dippers (n=34, 42%).
  • Non-embracers (n=23, 28%).

Table 5 shows examples of each type of user. 

Embracers were defined as reporting good adherence to the programme, and describing behavioural and attitudinal changes. 

Dippers reported dipping into components of the programme such as the relaxation tape or the physical activity aspects. Alternatively, Dippers adhered to the programme until distracting life events occurred, such as a spouse became ill, they went on holiday or they became busy at work. They used the programme as an information resource and attempted some behavioural change, which was not always sustained during the trial period. 

Non-embracers were defined as reporting little or no change in attitude or behaviour, although they may report gaining new information. Since they often reported finding nothing they did not already know, they cannot be regarded as not embracing self-management, only as not embracing the Diabetes Manual. 

The Diabetes Manual website features a podcast of an individual who “embraced” the Diabetes Manual in the trial, and especially found the emotional support provided in the programme very positive (available at: www2.warwick.ac.uk/fac/med/study/cpd/subject_index/diabetes/manual/). She reported the following benefits: 

“Since I’ve had the Manual, you can look through that, you can think should I be feeling like this, is it wrong to feel like this, has someone else felt like this and how did they cope with it? … You’re not on the end of the phone bugging the nurse or down at the doctor … It gives them [people with diabetes] a sense of independence.”

Is the Diabetes Manual programme a feasible programme for one-to-one structured education in primary care?
Once the trial was completed, all the intervention nurses were invited to take part in a focus group with the aim of understanding their experience of facilitating the Diabetes Manual in primary care. A discussion schedule was developed to enquire about the feasibility and appropriateness of practice nurses delivering the Diabetes Manual, and the extent to which the facilitator training had prepared them for their role. Following a single letter of invitation, 11 of the 23 facilitators (48%) who had been using the manual with people with diabetes agreed to participate. The focus group was facilitated by a senior teaching fellow in diabetes experienced in this method and a medical student undertaking an undergraduate research scholarship. Once informed consent was obtained from participants, the focus group was audio-recorded, transcribed and thematic analysis undertaken by the focus group facilitator and the author, with three strong themes emerging from this single focus group around (i) job satisfaction, (ii) an indication that the nurses had an instinct about who would benefit from it and (iii) preparedness for the role.

Job satisfaction
Using the Diabetes Manual had a positive impact on the nurses’ job satisfaction. They felt more confident and skilled, it extended their own learning and practice experience, and confirmed for them that they were already delivering the correct information. 

“[I feel] good, simply good because … what we are doing is having an impact on their life and they can see the impact it’s having on their life.” (nurse 6)

“That’s the benefit of it … That frustration has gone – that sort of pressure that you’re not achieving anything and actually now they can do it for themselves.” (nurse 4)

This indicates that the nurses felt they were now able to structure the education components of their consultations, but also warns that there is a danger of passing the whole responsibility to the person with diabetes along with the Diabetes Manual resources, and there may be some need to assess a person’s readiness for this.

Who should it be offered to? 
During the trial, the facilitators had been restricted by the inclusion and exclusion criteria, which meant that they were not able to offer it to the people they particularly had felt would find it useful. They felt that HbA1c was not always the most appropriate indicator of whether someone would benefit from a structured education programme, and that there were other criteria, such as time since diagnosis, that may be more useful.

“[The manual might be useful] 6 or 12 months in, when they get stuck, but when they’ve sort of tried living with diabetes …”
(nurse 5)

The practice nurse facilitators were clear about which individuals they would have liked to have offered the Diabetes Manual to, and who would have engaged with it:

“You think: ‘If only I could just give you this manual’…” (nurse 3)

“Yes, because they’re looking for something but you haven’t got the time to give them [it] in surgery.” (nurse 6)

“Well, actually, I did, I actually gave one [non-trial] person the manual.” (nurse 7)

This dialogue between three of the facilitators draws out many of the challenges facing practice nurses in the delivery of diabetes care: identifying patient need, and being constrained in meeting that need because of both internal (time and workload) and external (PCT policy) factors. 

Group-based programmes are effective and efficient learning environments, but it is increasingly recognised that they do not suit everyone. In their study of self-management education in coronary heart disease, Dalal and Evans (2004) found that older people, the self-employed and the rurally located preferred a home-based one-to-one programme to a centrally based (for example, hospital or PCT) group programme. Many people have caring and work-related responsibilities that demand a flexible approach to learning. There are also people for whom a group programme is impossible, such as those with severe mental health problems or in custody. Feedback from the RCT and, subsequently, from the trained facilitators, has shown that the Diabetes Manual is a feasible progr amme for one-to-one delivery of structured education.

How prepared were the nurses to become Diabetes Manual facilitators?
The trial facilitators reported that the facilitator training met their needs, and they felt confident on completion. They acknowledged  that they had difficulty in recalling theory surrounding unfamiliar elements of care delivery, such as telephone support calls or consultation techniques, once they were back in the practice situation:

“And then I ended up asking yes and no questions as opposed to open questions … and then you sort of go back and try and think why do they keep saying yes or no when that’s not what I’m asking them
(nurse 7)

Several nurses reported using the techniques outside diabetes care with people with other long-term conditions: 

“I found it was sort of beneficial with all chronic disease … it’s meeting the [nGMS] contract quite well.” (nurse 3)

Since the trial, two Diabetes Manual facilitator courses have been undertaken by a broader range of health professionals, several of whom have also been trained to deliver group-based structured education. As a consequence of course evaluations from these facilitators regarding overlapping aspects of the one-to-one and group-based curriculums, such as philosophy, theory and empowering communication skill development, a 1-day Diabetes Manual facilitator training course has been developed for health professionals who are already delivering group-based structured education. This training will run alongside the 2-day courses designed for those unfamiliar with diabetes structured education.

Conclusion
The Diabetes Manual is a feasible and appropriate form of structured education for one-to-one use with people with type 2 diabetes. Trial participants demonstrated improved confidence in self-managing their diabetes and a reduction in their diabetes anxiety levels. 

The research has shown that the Diabetes Manual benefits the majority of individuals on the course and results in considerable improvements in diabetes management for some. Further research is being undertaken to establish who might benefit most from the Manual, and how to make it more effective in improving both psychosocial and clinical outcomes for a broader range of individuals.

REFERENCES:

Dalal HM, Evans PH (2004) British Medical Journal 326(7387): 481–4
Department of Health (2005) Structured Patient Education in Diabetes: Report from the Patient Education Working Group.Department of Health, London
Department of Health, National Diabetes Support Team and Diabetes UK (2006) How to Assess Structured Diabetes Education: An improvement toolkit for commissioners and local diabetes communities.www.diabetes.org.uk/Professionals/Shared_Practice/Care_Topics/Patient_education/Structured_Education_Self_Assessment_Toolkit/(accessed 28.11.08)
Diabetes Education Network (2008) Available at: www.diabetes-education.net (accessed 28.11.08)
Healthcare Commission (2007) Managing Diabetes: Improving Services for People with Diabetes. Service Review.Commission for Healthcare Audit and Inspection, London
Loveman E, Frampton GK, Clegg AJ (2008) Health Technology Assessment 12(9): 1–116, iii
NICE (2003) Guidance on the Use of Patient-education Models for Diabetes. Technology Appraisal 60. NICE, London
Sturt J, Hearnshaw H (2003) Diabetic Medicine 20(Suppl 2): 78
Sturt J, Taylor H, Docherty A, Dale J, Louise T (2006a) BMC Family Practice 7: 70
Sturt J, Hearnshaw H, Farmer A, Dale J, Eldridge S (2006b) BMC Family Practice 7: 45
Sturt JA, Whitlock S, Fox C et al (2008) Diabetic Medicine 25(6): 722–31
Welch G, Weinger K, Anderson B, Polonsky W (2003) Diabetic Medicine 20: 69–72

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